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Most expensive breast cancer treatments not always most effective

Researchers say oncologists should consider cost when prescribing

Drug costs have increased significantly in recent years, at times even`becoming a political issue. The drugs that seem to increase the most are specialty drugs, like those used to treat chronic diseases, such as cancer.

Researchers at the University of Texas MD Anderson Cancer Center have found the cost of different breast cancer chemotherapy treatments can vary widely, with little or no correlation to effectiveness.

Dr. Sharon Giordana, chair of Health Services Research, says an understanding of costs should play a role in helping doctors and patients decide on a course of treatment.

"The costs of cancer care have been increasing dramatically, both for the health care system and for patients. As physicians, we increasingly are recognizing the financial burden on our patients," said Giordano. "Both physicians and patients need greater access to information about the treatment costs, so this critical issue can be discussed during a patient's decision making process."

Cut costs by $1 billion a year

Giordana cites estimates from the American Cancer Society that there are more than 246,000 new cases of invasive breast cancer each year in the U.S. Since more than a third of these patients will be treated with chemotherapy, Giordana says choosing a therapy that is just as effective, but less costly, could shave $1 billion a year off the nation's health care bill.

A recent study by researchers at the University of North Carolina concluded that cancer drug inflation is a very real thing. Specifically, the researchers found that when a new cancer drug comes on the market, its initial cost is much higher than the initial costs of drugs introduced a decade or more ago.

Six times more expensive

Their study determined that a month's worth of treatment with the newest cancer drugs, on the market since 2014, were, on average, six times more expensive than the launch prices of similar drugs introduced in 2000, even after adjusting for inflation.

In the Texas study, researchers focused on younger patients who had private health insurance. Giordano says patients without private health insurance likely face even higher out-of-pocket expense for chemotherapy.

For that reason, she says oncologists need to prescribe the most effective treatments, while being aware of the substantial financial burden associated with chemotherapy.

Drug costs have increased significantly in recent years, at times even`becoming a political issue. The drugs that seem to increase the most are specialty d...

Fruits and vegetables early in life linked to lower risk of breast cancer later

Findings indicate that high consumption rates can reduce the risk by 25%

You may have heard of the old adage that “An apple a day keeps the doctor away,” but it may be more true than many of us realized. A new study has linked higher consumption of fruits and vegetables in adolescence with lowered risk of breast cancer later in life.

Up until this point, some experts had posited that eating fruits and vegetables affected breast cancer risk, but many established studies had only analyzed these eating habits for middle-aged or older individuals.

In order to rectify this, a team of researchers followed a group of 90,000 nurses in early adulthood over the course of 20 years, asking the participants to report on their diets and recall how they ate when they were younger. They found that those who consumed a high amount of fruits and vegetables (2.9 servings per day versus .5 servings per day) had a 25% lower risk of breast cancer when they reached middle-age.

The researchers also found that certain fruits and vegetables had particularly strong ties to lower risks of breast cancer. They included foods like apples, bananas, grapes, oranges, and kale.

Interestingly, consumption of fruit juices in adolescence did not have any tangible effect on breast cancer risk, suggesting that eating the whole versions of these products was more beneficial.

The full study has been published in The BMJ.

You may have heard of the old adage that “An apple a day keeps the doctor away,” but it may be more true than many of us realized. A new study has linked h...

Breast cancer researchers raise warning about too much sugar

Sugar industry responds that results are being "sensationalized"

Cancer researchers in Texas have a word of advice for women at risk of breast cancer – go easy on the sugar.

In a report, the University of Texas MD Anderson Cancer Center said high amounts of sugar, prevalent in the typical Western diet, may increase the risk of breast cancer and metastasis to the lungs.

The findings zeroed in on dietary sugar's effect on an enzymatic signaling pathway known as 12-LOX.

"We found that sucrose intake in mice comparable to levels of Western diets led to increased tumor growth and metastasis, when compared to a non-sugar starch diet," said Peiying Yang, assistant professor of Palliative, Rehabilitation, and Integrative Medicine. "This was due, in part, to increased expression of 12-LOX and a related fatty acid called 12-HETE."

There have been a few previous studies that looked for links between sugar and breast cancer. Some of these studies have suggested high levels of sugar can affect inflammation, which can be associated with cancer development.

"The current study investigated the impact of dietary sugar on mammary gland tumor development in multiple mouse models, along with mechanisms that may be involved," said co-author Lorenzo Cohen, professor of Palliative, Rehabilitation, and Integrative Medicine. "We determined that it was specifically fructose, in table sugar and high-fructose corn syrup, ubiquitous within our food system, which was responsible for facilitating lung metastasis and 12-HETE production in breast tumors."

Industry response

The sugar industry was quick to respond to the study. The Sugar Association, a trade group, points out the results were based only on animal studies and charged the results are being sensationalized.

“As with other studies on this subject, this study has serious limitations that should be disclosed, particularly when the headlines are as serious as these have been,” the group said in a statement. “Not only do the authors misstate and exaggerate current U.S. sugar consumption and trends in consumption, they also claim the mice in the study were fed sugar levels comparable to levels in a Western diet. Yet, the data provided shows the mice were fed massive amounts of fructose (as part of sucrose) with the lowest level of fructose fed more than double U.S. consumption.”

But the authors say identifying risk factors for breast cancer is a public health priority. They say moderate sugar consumption is critical, and disagree with the Sugar Association about the current level of per capita consumption, claiming it is over 100 pounds per year.

The industry, however, may be correct in its contention that it is an over-estimate. As the New York Times reported in 2012, the Department of Agriculture lowered its estimate of per capita sugar consumption to 76.7 pounds annually.

Cancer researchers in Texas have a word of advice for women at risk of breast cancer – go easy on the sugar.In a report, the University of Texas MD And...

Elevated breast cancer risk for African American women using hormone supplements

The overall increase in risk was as high as 50% in one study

African American women who use certain types of female hormone supplements face a sharply increased risk of breast cancer, a new study finds. Previous studies had found a higher risk for white women, but it wasn't known whether the same effects would be seen in black women.

The study, published in the Journal of the National Cancer Institute, found the overall increase in risk was 50%, with even higher increases for recent and long-term users.

The study looked specifically at postmenopausal African American women who used female hormone supplements containing estrogen and progestin ("combination" therapy).

"The present findings establish that combination therapy in black women is associated with increased risk of estrogen receptor positive breast cancer, similar to the pattern in white women," said corresponding author Lynn Rosenberg, ScD, associate director of the Slone Epidemiology Center and principal investigator of the Black Women's Health Study, one of the studies that contributed to this conclusion. "Our findings highlight the importance of black women limiting their use of combination therapy."

This is a report of research findings. It should not be used by patients to make unilateral decisions about their care or to start or stop prescribed medications. If you have concerns about female hormone supplements, you should discuss them with your doctor, mentioning this study. 

White women show similar results

Similar to findings in white women, use of combination therapy was associated with increased risk of estrogen receptor positive breast cancer, with risk increasing as the duration increased. The risk declined after cessation of use but was still somewhat elevated up to 10 years later.

There was no increase in risk associated with use of estrogen alone, nor was there any increase in risk of estrogen receptor negative breast cancer associated with use of either combination therapy or estrogen alone.

According to Rosenberg, the latter point is particularly important because recent national cancer statistics indicate that breast cancer incidence has been increasing among African American women and converging to the rate of white women, while the death rates continue to diverge between the groups.

Researchers from the Slone Epidemiology Center at Boston University led the investigation using data from the four large studies of black women included in the AMBER (African American Breast Cancer Epidemiology and Risk) Consortium.

African American women who use certain types of female hormone supplements face a sharply increased risk of breast cancer, a new study finds. Previous stud...

Mediterranean diet may reduce breast cancer risk

Spanish researchers think extra virgin olive oil could be the secret

Health experts have for some time recommended the Mediterranean diet as a healthy eating plan. It is heavy on fruits and vegetables, fish, and olive oil.

According to the Mayo Clinic, research shows that the traditional Mediterranean diet reduces the risk of heart disease.

“In fact, an analysis of more than 1.5 million healthy adults demonstrated that following a Mediterranean diet was associated with a reduced risk of death from heart disease and cancer, as well as a reduced incidence of Parkinson's and Alzheimer's diseases,” the Mayo Clinic staff notes.

Spanish researchers now add reducing the risk of breast cancer to the list of attributes. Scientists at the University of Navarra set out to determine the effects of the Mediterranean diet on the primary prevention of chronic diseases.

Cut risk by two-thirds

It found the diet cut the risk of developing breast cancer by two-thirds.

The participants, all from Spain, followed three types of diet; two were versions of the Mediterranean diet, which heavily relied on extra virgin olive oil and was supplemented by nuts.

Those diets confirm a lower incidence of breast cancer, which is almost a third of that in the control group. The researchers conclude it is the extra virgin olive oil that probably makes the difference.

"All this despite the fact that the control group or comparison group also followed a diet already healthy, which suggests that the results could have been even more significant had it been compared to a dietary pattern as the followed in non-Mediterranean Western countries,” said Dr. Miguel Angel Martinez-Gonzalez, a member of the research team.

Preventive strategy

Doctors generally agree that preventive strategies provide the most effective tool to combat breast cancer. The Spanish researchers say having the Mediterranean diet as one of these tools is all the better, since it can also be a tool to promote general health.

Previous research has suggested the Mediterranean diet is linked to lower risk of diabetes and even improves brain function in aging adults.

Key components of the Mediterranean diet

The Mediterranean diet emphasizes:

  • Consuming mostly plant-based foods, such as fruits and vegetables, whole grains, legumes, and nuts
  • Skipping the butter and instead going with healthy fats like olive oil
  • Flavoring food with herbs and spices instead of salt
  • Going easy on red meat – no more than a few times a month
  • Eating fish and poultry at least twice a week
  • Enjoying some red wine in moderation, though that's considered an option

The diet also recognizes the importance of being physically active, and enjoying meals with family and friends.

Health experts have for some time recommended the Mediterranean diet as a healthy eating plan. It is heavy on fruits and vegetables, fish, and olive oil....

New drug approved for treatment of nausea and vomiting from chemotherapy

The drug is available in tablet form

Varubi (rolapitant), a drug that prevents delayed phase chemotherapy-induced nausea and vomiting (emesis), has won approval from the Food and Drug Administration (FDA).

 

The drug is approved for use by adults in combination with other drugs (antiemetic agents) that prevent nausea and vomiting associated with initial and repeat courses of vomit-inducing (emetogenic and highly emetogenic) cancer chemotherapy.

 

Nausea and vomiting are common side effects experienced by cancer patients undergoing chemotherapy. Symptoms can persist for days after the chemotherapy drugs are administered. Nausea and vomiting that occurs from 24 hours to up to 120 hours after the start of chemotherapy is referred to as delayed phase nausea and vomiting. It can result in serious health complications such as weight loss, dehydration and malnutrition in cancer patients, leading to hospitalization.

 

“Chemotherapy-induced nausea and vomiting remains a major issue that can disrupt patients' lives and sometimes their therapy,” said Amy Egan, M.D., M.P.H., deputy director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research. The approval, she continued, “provides cancer patients with another treatment option for the prevention of the delayed phase of nausea and vomiting caused by chemotherapy.”

 

Safe and effective

 

Varubi is a substance P/neurokinin-1 (NK-1) receptor antagonist. Activation of NK-1 receptors plays a central role in nausea and vomiting induced by certain cancer chemotherapies, particularly in the delayed phase. Varubi is provided to patients in tablet form.

 

The safety and efficacy of Varubi were established in three randomized, double-blind, controlled clinical trials where Varubi in combination with granisetron and dexamethasone was compared with a control therapy (placebo, granisetron and dexamethasone) in 2,800 patients receiving a chemotherapy regimen that included highly emetogenic (such as cisplatin and the combination of anthracycline and cyclophosphamide) and moderately emetogenic chemotherapy drugs.

 

Those patients treated with Varubi had a greater reduction in vomiting and use of rescue medication for nausea and vomiting during the delayed phase compared to those receiving the control therapy.

 

The most common side effects in patients treated with Varubi include a low white blood cell count (neutropenia), hiccups, decreased appetite and dizziness.

 

Varubi is marketed by Tesaro Inc. , based in Waltham, Massachusetts.

 

 

 

Varubi (rolapitant), a drug that prevents delayed phase chemotherapy-induced nausea and vomiting (emesis), has won approval from the Food and Drug Administ...

Discovery of new marker for basal-like breast cancer could speed diagnosis, treatment

Researchers hope that their findings could benefit people with other forms of cancer as well

There may be new hope for people suffering with breast cancer. Researchers from the Boston University School of Medicine and University of Cyprus are currently looking into a way of detecting and treating one of the most fatal forms of the disease: basal-like breast cancer (BLBC).

BLBC is a particularly vicious form of breast cancer that professionals refer to as a “triple negative”. This means that it cannot be treated with medical therapies that are commonly used in other forms of cancer. BLBC also spreads through the body much more quickly, and those who develop it have a smaller chance of survival. African Americans and women under the age of 40 are most likely to develop the disease, and once it has spread through the body, doctors have a very limited ability to treat it.

Finding markers

Doctors have struggled with BLBC because, up to this point, there have been no clear indicators or markers for when the disease will flourish. If these were discovered, doctors would be able to react and respond much more quickly to the disease, and certain drugs and alternative treatments could be developed. Luckily, researchers are already well on their way to accomplishing this feat.

Scientists discovered an indicator for BLBC when they were examining markers on the surface of cancer cells. They compared these markers with genes from breast cancer tumors that were recorded in public databases. They found that a certain molecule, designated as IL13RA2, was plentiful in metastatic, or late-stage, BLBC. With this knowledge, they were able to predict the chances of progression-free survival based on how high the levels of these molecules were in cancer cells. In short, certain types of BLBC tended to spread quickly to the lungs if they had high levels of IL13RA2.

Extended benefits

Although this seems to be a positive marker for BLBC, the good news does not stop there. Scientists found that if they reduced the amount of IL13RA2 in cancer cells, then the growth of the tumors decreased dramatically. This caused the cancer cells to have a very low rate of spreading to the lungs, and suggests that IL13RA2 is a major factor in cancer growth.

“This discovery offers a glimmer of hope for patients stricken with BLBC. Personalized cancer therapies could be developed by targeting breast cancer cells that express copious levels of IL13RA2,” said Sam Thiagalingam, who co-authored the study.

The researchers are hopeful that their discovery may lead to breakthroughs with other forms of cancer as well. High levels of IL13RA2 are common in many forms of the disease, so investigating it further has the potential to provide tremendous results. The full study has been published in Breast Cancer Research

There may be new hope for people suffering with breast cancer. Researchers from the Boston University School of Medicine and University of Cyprus are curre...

Geography plays a role in early cancer diagnosis

A state's regulatory policies can be a matter of life and death, study finds

Whether or not someone survives cancer often depends on when the disease is diagnosed. If it is caught early then the odds are better, but a late-stage diagnosis is often a death sentence.

Now, a research team from Georgia State University and the University of North Carolina has determined where a patient lives can make a big difference in whether their cancer is caught early or late.

The team's study found that individual state regulations for health insurance and practitioners significantly influence when patients receive colorectal or breast cancer diagnoses, especially among people younger than the Medicare-eligible age of 65. This suggests that where a person lives is a strong predictor of whether they will receive potentially life-saving cancer screenings.

Dr. Lee Rivers Mobley, associate professor at Georgia State's School of Public Health, has spent years exploring similar issues. He was the principal author of "United States Health Policies and Late-Stage Breast and Colorectal Cancer Diagnosis: Why Such Disparities by Age?", which was recently published in Health Economics Review.

Disparities of geography

Now, he's focusing his attention on disparities that exist between different geographic regions.

"Progress has been made in the war against cancer, yet the high proportions of late-stage diagnoses remain a public health concern," the researchers wrote.

Their analysis discovered that 54% to 60% of colorectal cancer diagnoses are late-stage, meaning the disease has spread. The analysis found 24% to 36% of breast cancer cases are caught at the late stage.

The conclusion? A state's regulatory climate is "an important predictor" of late-stage colorectal and breast cancer diagnoses.

The study reached its conclusion after examining individual states' regulatory policies, matching them with their colorectal and breast cancer diagnoses. It used the United States Cancer Statistics (USCS) database and examined data that was reported between 2004 and 2009 in order to determine whether area cancer screening use or accessibility to health care providers affected odds of late-stage diagnosis.

States requiring health insurance providers to offer more screenings had fewer late stage diagnoses.

Common cancers

Colorectal cancer is the second leading cause of cancer deaths in the U.S. and the risk of developing it rises after age 40. Overall rates of the disease have been on the decline, largely because of endoscopic screenings and polyp removal.

However, rates have been rising since 1998 among those younger than age 50 "for whom screening is not routinely recommended," the authors said.

Breast cancer is the second leading cause of cancer deaths among women and its rates have remained steady since about 2003.

According to the Colon Cancer Alliance, 90% of those diagnosed when the cancer is found at a local stage – confined to colon or rectum – survive more than five years. Unfortunately, the association says only 40% of colon cancers are diagnosed at the early, local stage.

Whether or not someone survives cancer often depends on when the disease is diagnosed. If it is caught early then the odds are better, but a late-stage dia...

Study finds daily aspirin can block breast cancer growth

A similar effect was previously found in other types of cancer

Aspirin is good for a lot of things. But who would have thought a daily aspirin could block breast tumor growth? That's the finding of a lab study being published in the July 2015 issue of Laboratory Investigation.

Previous studies have shown a similar effect on colon, gastrointestinal, prostate, and other cancers.

The trick, says Dr. Sushanta Banerjee, research director of the Cancer Research Unit at the Kansas City, Mo. Veterans Affairs Medical Center, is to ensure conditions around cancer stem cells aren't conducive for reproduction, something aspirin seems able to do.

"In cancer, when you treat the patient, initially the tumor will hopefully shrink," says Banerjee. "The problem comes 5 or 10 years down the road when the disease relapses."

Cancer has stem cells, or residual cells. They can survive chemotherapy or other cancer treatment and go dormant until conditions in the body are more favorable for them to again reproduce. "When they reappear they can be very aggressive, nasty tumors," Banerjee says.

Study details

To test his theory that aspirin could alter the molecular signature in breast cancer cells enough that they wouldn't spread, Banerjee used both incubated cells and mouse models.

For the cell test, breast cancer cells were placed in 96 separate plates and then incubated. Just over half the cultures were exposed to differing doses of acetylsalicylic acid, commonly known as aspirin.

According to Banerjee, exposure to aspirin dramatically increased the rate of cell death in the test. For those cells that did not die off, many were left unable to grow.

The second part of his study involved studying 20 mice with aggressive tumors. For 15 days, half the mice were given the human equivalent of 75 milligrams of aspirin per day, which is considered a low dose. At the end of the study period, the tumors were weighed. Mice that received aspirin had tumors that were, on average, 47 percent smaller.

To show that aspirin could also prevent cancer, the researchers gave an additional group of mice aspirin for 10 days before exposing them to cancer cells.

After 15 days, those mice had significantly less cancerous growth than the control group.

"We found aspirin caused these residual cancer cells to lose their self-renewal properties," says Banerjee. "Basically, they couldn't grow or reproduce. So there are two parts here. We could give aspirin after chemotherapy to prevent relapse and keep the pressure on, which we saw was effective in both the laboratory and the mouse model, and we could use it preventatively."

Experts suggest patients consult with a doctor before starting a daily aspirin regimen. The drug is known to thin the blood and increase the risk of gastrointestinal bleeding.

"Of course there is a risk," says Banerjee, "but you have to weigh that against the risks of cancer. It's true this is relatively new and we don't know all the side effects yet, but this was a very low dose."

Aspirin is good for a lot of things. But who would have thought a daily aspirin could block breast tumor growth? That's the finding of a lab study being pu...

Researchers develop genetic breast cancer screening tool

Test combines many small risk factors into a single genetic risk score

In 2013, when actress Angelina Jolie revealed she underwent a double mastectomy because of a genetic risk of breast cancer, it heightened awareness that the mutation of the BRCA1 gene could lead to the deadly disease.

Suddenly, women the world over were getting tested for the mutation and many, like Jolie, opted for the preventive surgery.

Now, researchers led by doctors at the Mayo Clinic may have made it easier for women to assess any genetic anomalies they might have that could result in getting breast cancer. The scientists have found dozens of common genetic variants that are associated with the disease.

Common genetic variants

The researchers combined 77 of these common genetic variants into a single risk factor that can help identify women with an increased risk of breast cancer. This factor is known as a polygenic risk score and was compiled from the genetic data of more than 67,000 women.

“This genetic risk factor adds valuable information to what we already know can affect a woman’s chances of developing breast cancer,” said Celine Vachon, an epidemiologist at Mayo Clinic and the study’s co-author.

Based on the results, the researchers are now developing a test. Once it’s ready for clinical use, Vachon says it will allow improved personalized screening and prevention strategies for patients.

Scientists have known for decades that genetics can play a role in breast cancer. Like Jolie, women inheriting a mutation in BRCA1 and BRCA2 genes are at a significantly increased risk of developing the disease.

Jolie’s genetic mutation is rare

Jolie’s mother died from breast cancer and so did her aunt, at about the same time the actress announced her mastectomy.

Though Jolie’s public announcement prompted many women to seek genetic testing, the chances of most having the dangerous mutation were quite small. The Mayo scientists say the BRCA1 and BRCA2 mutations are rare and account for less than 5% of all breast cancers.

More common genetic variations known as single nucleotide polymorphisms, or SNPs, also contribute to cancer risk, but taken individually, they are too small to predict breast cancer risk.

The purpose of the Mayo Clinic-led research was to test whether the effects of these individual SNPs could be combined into a single risk factor for breast cancer, that could then be used as a screening tool. It appears that they can.

Polygenic risk score

The research team used the results of their study to compile a polygenic risk score that they say could successfully place women into different categories of risk. For example, compared to women with an average polygenic risk score, women in the top 1% are 3 times more likely to develop breast cancer.

At the same time, women in the bottom 1% of the polygenic score are at a 70% lower risk of developing breast cancer. The researchers believe the score can become a powerful tool, when used along with relevant information like family history, lifestyle risk factors, previous biopsies, and breast density.

“There have been a lot of common genetic variants associated with cancers, not just for breast cancer but also for ovarian cancer and prostate cancer, but so far we haven’t seen these being used in clinical practice,” Vachon said. “In the future, these factors are going to be helpful in defining who is at highest and lowest risk of cancer and help both patients and clinicians make better decisions about their care.”

In 2013, when actress Angelina Jolie revealed she underwent a double mastectomy because of a genetic risk of breast cancer, it heightened awareness that th...

Scientists think saccharin could be a cancer-fighting tool

It may destroy harmful protein, making other cancer drugs more effective

In the 1960s, when American consumers first began to worry about their waistlines, food manufacturers started using more of the artificial sweetener saccharin, as a sugar substitute.

It wasn't long before scientists were issuing warnings. Saccharin, they said, was linked to bladder cancer in rats.

It turns out it wasn't, but it took about 30 years for other scientists to reach that conclusion. Today, saccharin is still a widely used artificial sweetener and now, in something of an irony, might turn out to be an effective weapon against some types of cancer.

In information presented this week at the American Chemical Society (ACS) meeting in Denver, researchers shared tantalizing findings that suggest this popular sugar substitute could potentially play a role in the development of drugs capable of combating aggressive, difficult-to-treat cancers with fewer side effects.

Untapped uses

“It never ceases to amaze me how a simple molecule, such as saccharin — something many people put in their coffee everyday — may have untapped uses, including as a possible lead compound to target aggressive cancers,” said Robert McKenna, of the University of Florida. “This result opens up the potential to develop a novel anti-cancer drug that is derived from a common condiment that could have a lasting impact on treating several cancers.”

Without getting too technical, the scientists working with saccharin found it binds to and deactivates a protein found some some of the more aggressive forms of cancer, such as in the breast, lung, liver, kidney, pancreas and brain.

The researchers believe a saccharin-based drug could slow the growth of these cancers and maybe make them less resistant to chemo or radiation therapies.

The destructive protein attacked by saccharine is very similar to other substances that the body needs to keep cells healthy. Previous drug candidates have all damaged the healthy proteins as well as the cancer-causing one.

Building on previous work

But in previous research, scientists at the University of Florence, Italy, discovered that saccharin inhibits the actions of the harmful protein but not the 14 other carbonic anhydrase proteins that are vital to human survival.

In other words, saccharine only attacks the harmful protein while ignoring the healthy ones.

Building on this finding, a team of researchers at Griffith University, Australia, created a compound in which a molecule of glucose was chemically linked to saccharin.

This small change turned out to have big effects. Not only did it reduce the amount of saccharin needed to inhibit the harmful protein, the compound was 1,000 times more likely to bind to the enzyme than saccharin.

Using X-ray crystallography, McKenna and his students Jenna Driscoll and Brian Mahon are investigating how saccharin-based compounds might be tweaked to enhance their anti-cancer treatment potential.

McKenna’s team is currently testing the effects of saccharin and saccharin-based compounds on breast and liver cancer cells. If successful, these experiments could lead to animal studies.

In the 1960s, when American consumers first began to worry about their waistlines, food manufacturers started using more of the artificial sweetener saccha...

Osteoporosis drug may fight cancer

But first it must win approval for that new use

There have been a number of promising breakthroughs recently on new cancer drugs. But the testing and approval process for a major new drug can take years, and even then still not make it onto the market.

When a drug already approved for one application turns out to be effective in another, getting Food and Drug Administration (FDA) approval for the new use usually takes much less time.

When the drug in question appears to be effective in the fight against cancer, it's an even more hopeful development. So researchers are excited by their discovery that the most commonly used medications to treat osteoporosis, bisphosphonates, may also prevent certain kinds of lung, breast and colon cancers.

The findings are contained in not 1, but 2 studies led by researchers at New York's Icahn School of Medicine at Mount Sinai and published in the Proceedings of the National Academy of Sciences (PNAS).

Previous studies have noted that bisphosphonates had been associated with a slowdown in tumor growth in some patients but not others. The reason, however, remained a mystery.

Solving the mystery

The new studies claim to clear up much of the mystery. Bisphosphonates block the abnormal growth signals passed through the human EGF receptors (HER), including the forms of this protein family prevent many cancer treatments from being effective.

The connection turned up in a database study and then was confirmed in studies of human cancer cells and in mice. The team of international researchers concludes that the war on cancer may soon have a new weapon.

“Our study reveals a newfound mechanism that may enable the use of bisphosphonates in the future treatment and prevention of the many lung, breast and colon cancers driven by the HER family of receptors,” said lead study author Mone Zaidi. “Having already been approved by the FDA as effective at preventing bone loss, and having a long track record of safety, these drugs could be quickly applied to cancer if we can confirm in clinical trials that this drug class also reduces cancer growth in people. It would be much more efficient than starting drug design from scratch.”

The process

The process works like this: the FDA reviews a company's New Drug Application (NDA) for clinical trial data to see if the results support the drug for a specific use or indication, in this case treating or preventing specific cancers.

If the agency is satisfied that the drug is safe and effective, the drug's manufacturer and the FDA agree on specific language describing dosage and other information to be included on the drug's label. More detail is then provided in the drug's package insert.

The National Institutes of Health (NIH) calls finding new uses for existing drugs “a major step forward in drug discovery.” NIH researchers have spent the last 3 years testing over 100 other drugs that might have therapeutic effects on different diseases.

"This work is still in an early stage, but it is promising proofs of principle for a creative, fast and affordable approach to discovering new uses for drugs we already have in our therapeutic arsenal," said Dr. Rochelle M. Long, Director of the NIH Pharmacogenomics Research Network.

But there could be an obstacle to deploying bisphosphonates in the fight against cancer. Zaidi says at the moment, there is no business model for carrying out the costly clinical trials that would be needed to re-purpose bisphosphonates for cancer. He says drug companies probably won't pay for research to develop generic drugs where there is no chance of patent protection or profit.

He says it might require non-traditional sources of funding such as the federal government or private, non-profit organizations.

There have been a number of promising breakthroughs recently on new cancer drugs. But the testing and approval process for a major new drug can take years,...

Breast-conserving therapy better than mastectomy in some cases, study finds

The findings defy conventional beliefs, say MD Anderson researchers

A new study finds that breast-conserving therapy may offer a greater survival benefit than mastecomy to women with early stage, hormone-receptor positive disease. 

The study findings defy the conventional belief that the two treatment interventions offer equal survival, and show the need to revisit some standards of breast cancer practice in the modern era, say researchers at the University of Texas MD Anderson Cancer Center.

In the 1980s, studies concluded that breast conservation (BCT) and mastectomy offered women with early stage breast cancer equal survival benefit. However, those findings come from a period in time when very little was understood about breast cancer biology, said Isabelle Bedrosian, M.D., associate professor, surgical oncology at MD Anderson.

"Forty years ago, very little was known about breast cancer disease biology – such as subtypes, differences in radio-sensitivities, radio-resistances, local recurrence and in metastatic potential," said Bedrosian, the study's senior author. "Since then, there's been a whole body of biology that's been learned – none of which has been incorporated into patient survival outcomes for women undergoing BCT or a mastectomy.

"We thought it was important to visit the issue of BCT versus mastectomy by tumor biology," Bedrosian continues.

But Bedrosian cautioned that the findings, while provocative, should still be regarded as preliminary. She said that the use of radiation therapy in breast conservation therapy may be a factor in the overall survival numbers, 

Study details

For the retrospective, population-based study, the researchers used the National Cancer Database (NCDB), a nation-wide outcomes registry of the American College of Surgeons, the American Cancer Society and the Commission on Cancer that captures approximately 70% of newly-diagnosed cases of cancer in the country. They identified 16,646 women in 2004-2005 with Stage I disease that underwent mastectomy, breast conserving surgery followed by six weeks of radiation (BCT), or breast conserving surgery without radiation (BCS).

Of the 16,646 women: 1,845 (11%) received BCS; 11,214 (67%) received BCT and 3,857 (22%) underwent a mastectomy. Women that had BCT had superior survival to those that had a mastectomy or BCS – the five-year overall survival was 96%, 90% and 87%, respectively. After adjusting for other risk factors, the researchers again found an overall survival benefit for BCT compared to BCS and mastectomy. 

"While retrospective, I think our findings should give the breast cancer community pause. In the future, we may need to reconsider the paradigm that BCT and mastectomy are equivalent," she says. "When factoring in what we know about tumor biology, that paradigm may no longer hold true."

The research was presented at the 2014 Breast Cancer Symposium by Catherine Parker, MD, formerly a fellow at MD Anderson, now at the University of Alabama Birmingham.

 

A new study finds that breast-conserving therapy may offer a greater survival benefit than mastecomy to women with early stage, hormone-receptor positive d...

Aspirin may help protect obese breast cancer patients

Texas researchers find it reduces cancer recurrence by 52% in some patients

Doctors have known for some time that obesity is linked to a higher risk of a recurrence of breast cancer. The National Cancer Institute says studies have suggestedthat extra body fat can cause hormonal changes and inflammation that may cause breast cancer to spread, even if the patient is receiving treatment.

But new research suggests something as simple and inexpensive as taking aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) may cut this recurrence of hormone-related breast cancer in half.

"Our studies suggest that limiting inflammatory signaling may be an effective, less toxic approach to altering the cancer-promoting effects of obesity and improving patient response to hormone therapy," said Linda deGraffenried, associate professor of nutritional sciences at The University of Texas in Austin.

NSAIDs may improve treatment

DeGraffenried participated in a study, published in Cancer Research, that found women whose body mass index (BMI) was greater than 30 and had estrogen receptor alpha (ER?)-positive breast cancer were 52% less likely to have a recurrence and a 28-month delay in time to recurrence if they were taking aspirin or other NSAIDs.

The research team says this is important because it suggests NSAIDS may improve the response to hormone therapy. If so, it would allow more women to continue with hormone therapy instead of switching to a more aggressive approach, such as chemotherapy.

"However, these results are preliminary and patients should never undertake any treatment without consulting with their physician," deGraffenried said.

DeGraffenried and others at the University of Texas worked with researchers at the Cancer Therapy & Research Center at The University of Texas Health Science Center (CTRC) at San Antonio to develop the theory. They began by examining blood serum from CTRC breast cancer patients.

The first part of the experiment yielded few surprises. The researchers placed the serum in a culture of fat cells that make estrogen, and then placed the serum on breast cancer cells.

Cancer cell growth

The serum obtained from overweight and obese patients caused the cancer cells to grow much more aggressively than the serum from patients who were not overweight.

"It looks like the mechanism is prostaglandins, which have a role in inflammation, and there's more of it in the obese patient serum," said CTRC oncologist Andrew Brenner.

Next, the researchers studied patients from the CTRC and the START Center for Cancer Care. They were divided into 2 groups – those taking aspirin or ibuprofen and those who did not.

The researchers say it appeared as though aspirin and other NSAIDs provided some protection, even after controlling for statins and omega-3 fatty acid use, which also have anti-inflammatory effects.

Inflammation is the key

"These studies show that the greatest benefit from aspirin and other NSAIDs will be in those with a disease driven by inflammation, and not just obesity," deGraffenried said.

While the findings may be good news for overweight and obese breast cancer patients, they also underscore the severity of the disease, and the heightened risk these patients face. DeGraffemried says they face a worse prognosis than normal-weight women.

"We believe that obese women are facing a different disease,” she said. “There are changes at the molecular level. We want to reduce the disease-promoting effects of obesity."

With the study's results in hand, the CTRC has kicked off a pilot anti-inflammatory trial in a joint venture with UT Austin, in hopes of conducting a larger study.

According to the American Cancer Society (ACS), breast cancer is the second most deadly cancer for women, right behind lung cancer. ACS projected 232,340 new cases of invasive breast cancer in 2013, with an expected 40,000 deaths from the disease.

Doctors have known for some time that obesity is linked to a higher risk of a recurrence of breast cancer. The National Cancer Institute says studies have ...

More Americans are surviving cancer

Early diagnosis and an aging pupulation are major factors

There is significant progress in the war on cancer in the U.S.

The good news is that a new report from the American Cancer Society estimates there are 14.5 million cancer survivors in the United States.

The better news is that the number will grow to almost 19 million by 2024.

The second edition of Cancer Treatment & Survivorship Facts & Figures, 2014-2015 and an accompanying journal article published in CA: A Cancer Journal for Clinicians find that even though cancer incidence rates have been decreasing for ten years, the number of cancer survivors is growing.

This is the result of increases in cancer diagnoses driven by the aging and growth of the population, as well as the fact that people are living longer with cancer because of earlier cancer detection and more effective treatments.

Common cancers

The three most common cancers among males living with a history of cancer in 2014 are prostate (43%), colorectal (9%), and melanoma (8%). Among women in 2014, the three most common cancers are breast (41%), uterine (8%), and colorectal (8%).

While lung cancer is the leading cause of cancer death and the second most commonly diagnosed cancer in both men and women, a low survival rate makes it the number 8 cancer site represented among survivors. The distribution of prevalent cancers is expected to be largely unchanged in 2024.

"The growing number of cancer survivors in the U.S. makes it increasingly important to understand the unique medical and psychosocial needs of survivors," said Carol DeSantis, MPH, American Cancer Society epidemiologist and lead author of the reports. "Despite the fact that awareness of survivorship issues has increased, cancer survivors face numerous, important hurdles created by a fractured health care system, poor integration of survivorship care, and financial and other barriers to quality care, particularly among the medically underserved. An important first step in addressing these challenges is to identify 'best practices' for the delivery of quality post-treatment cancer care."

Other findings

The report also found:

  • The majority of cancer survivors (64%) were diagnosed 5 or more years previously, and 15% were diagnosed 20 or more years ago.
  • Nearly one-half of cancer survivors (46%) are aged 70 years or older, while one in 20 (5%) is under age 40.
  • The age distribution of cancer survivors varies substantially by cancer type. For example, the majority of prostate cancer survivors (62%) are aged 70 and older, whereas less than one-third (32%) of melanoma survivors are in this age group.
  • By January 1, 2024, it is estimated that the population of cancer survivors will increase to nearly 19 million people (9.3 million males and 9.6 million females).

In addition to prevalence estimates, the reports include data on cancer treatment patterns, survival, and information on common short- and long-term effects of cancer and its treatment for eleven selected cancers.

Cancer Treatment and Survivorship Facts & Figures also contains sections on the effects of cancer and its treatment, impairment-driven cancer rehabilitation, palliative care, long term survivorship, the benefits of healthy behaviors, and resources for cancer survivors from the American Cancer Society and other organizations.

There is significant progress in the war on cancer in the U.S. The good news is that a new report from the American Cancer Society estimates there are 14....

Calorie restriction may improve breast cancer outcomes

Tests in mice find restricted diet lessens chance certain types of breast cancer will spread

Severely restricting calories has been suggested as a way of lengthening lifespans, and now a study finds that a very-low-calorie diet may also improve outcomes for women with breast cancer.

According to a study published May 26th in Breast Cancer Research and Treatment, the triple negative subtype of breast cancer – one of the most aggressive forms – is less likely to spread, or metastasize, to new sites in the body when mice were fed a restricted diet.

"The diet turned on a epigenetic program that protected mice from metastatic disease," says senior author Nicole Simone, M.D., an associate professor in the department of Radiation Oncology at Thomas Jefferson University.

Breast cancer patients are often treated with hormonal therapy to block tumor growth, and steroids to counteract the side effects of chemotherapy. However, both treatments can cause a patient to have altered metabolism which can lead to weight gain. In fact, women gain an average of 10 pounds in their first year of treatment.

Recent studies have shown that too much weight makes standard treatments for breast cancer less effective, and those who gain weight during treatment have worse cancer outcomes.

"That's why it's important to look at metabolism when treating women with cancer," says Dr. Simone.

In earlier studies, Dr. Simone and colleagues had shown that calorie restriction boosted the tumor-killing effects of radiation therapy.

In order to test the effects of a restricted diet in humans, Dr. Simone is currently enrolling patients in the CaReFOR (Calorie Restriction for Oncology Research) trial. As the first trial like it in the country, women undergoing radiation therapy for breast cancer receive nutritional counseling and are guided through their weight loss plan as they undergo their treatment for breast cancer.

Severely restricting calories has been suggested as a way of lengthening lifespans, and now a study finds that a very-low-calorie diet may also improve out...

Cancer death rates continue to drop

Middle-aged African American men are the biggest beneficiaries

Cancer death rates have been on the decline for the past two decades, according to the annual cancer statistics report from the American Cancer Society, leading to a 20% drop in the overall risk of dying from the disease over that time period.

The report, Cancer Statistics 2014, finds progress has been most rapid for middle-aged black men, among whom death rates have declined by approximately 50%. Despite this substantial progress, black men continue to have the highest cancer incidence and death rates among all ethnicities in the U.S. -- about double those of Asian Americans, who have the lowest rates.

Each year, the American Cancer Society estimates the numbers of new cancer cases and deaths expected in the United States in the current year and compiles the most recent data on cancer incidence, mortality, and survival based on incidence data from the National Cancer Institute and the Centers for Disease Control and Prevention, and mortality data from the National Center for Health Statistics. The data are disseminated in two reports, Cancer Statistics, published in CA: A Cancer Journal for Clinicians, and its companion article, Cancer Facts & Figures.

The cancer forecast

This year's report estimates there will be 1,665,540 new cancer cases and 585,720 cancer deaths in the United States in 2014. Among men, prostate, lung, and colon cancer will account for about half of all newly diagnosed cancers, with prostate cancer alone accounting for about one in four cases.

Among women, the three most common cancers in 2014 will be breast, lung, and colon, which together will account for half of all cases. Breast cancer alone is expected to account for 29% of all new cancers among women.

The estimated 585,720 deaths from cancer in 2014 correspond to about 1,600 deaths per day. Lung, colon, prostate, and breast cancers continue to be the most common causes of cancer death, accounting for almost half of the total cancer deaths among men and women. Just over one in four cancer deaths is due to lung cancer.

Declining incidence and deaths

During the most recent five years for which there are data (2006-2010), cancer incidence rates declined slightly in men (by 0.6% per year) and were stable in women, while cancer death rates decreased by 1.8% per year in men and by 1.4% per year in women.

The combined cancer death rate has been continuously declining for two decades, from a peak of 215.1 per 100,000 in 1991 to 171.8 per 100,000 in 2010. This 20 percent decline translates to the avoidance of approximately 1,340,400 cancer deaths (952,700 among men and 387,700 among women) during this time period.

The magnitude of the decline in cancer death rates from 1991 to 2010 varies substantially by age, race, and sex, ranging from no decline among white women aged 80 years and older to a 55% decline among black men aged 40 years to 49 years. Notably, black men experienced the largest drop within every 10-year age group.

"The progress we are seeing is good, even remarkable, but we can and must do even better," said John R. Seffrin, PhD, chief executive officer of the American Cancer Society. "The halving of the risk of cancer death among middle aged black men in just two decades is extraordinary, but it is immediately tempered by the knowledge that death rates are still higher among black men than white men for nearly every major cancer and for all cancers combined."

Cancer death rates have been on the decline for the past two decades, according to the annual cancer statistics report from the American Cancer Society htt...

Cancer survival rates on the rise

Researchers credit innovative treatments and new drugs

People with cancer are living longer after being diagnosed with the disease, leading researchers to conclude the world could be cancer-free by the middle of this century.

Statistics collected through the Value of Medical Innovation initiative, led by the Center for Medicine in the Public Interest (CMPI), show U.S. life expectancy for people with cancer has hit another all-time high, rising over 50 million life-years after diagnosis. The estimate is based on the number of additional years of life that each person diagnosed with cancer since 1990 has experienced.

"The benefits of medical innovation to patients and their families can be counted in birthdays, anniversaries, weddings and other life events that would have been missed if it weren't for medical innovation," said Scott Gottlieb, M.D., resident fellow for the American Enterprise Institute.

The numbers tell the story. In 1990, there were about six million cancer survivors in U.S. Today there are about 14 million. In 1990 about 57 percent of cancer patients could expect to live five years or more. Today, that number is nearly 70 percent.

Celebrity cases

Gottlieb said innovative therapies and improvements in healthcare system efficiency has fueled the improvement. Recent cancer cases involving celebrities provide a case in point.

At the start of the 2012 NFL season Indianapolis Colts head coach Chuck Pagano was forced from the sidelines after he was diagnosed with leukemia. After aggressive treatment Pagano's cancer was remarkably declared to be in remission just two months later. By the end of the season he had rejoined the team.

Doctors say that up to 90% of people diagnosed with Pagano's type of leukemia are eventually cured, thanks in part to a new medication that helps neutralize cancer cells.

In September Howard Stern sidekick Robin Quivers revealed that she had been treated for cancer in the pelvic region. After being diagnosed in late May 2012, Quivers underwent 12 hours of surgery in Pittsburgh to remove a grapefruit-sized cancerous tumor. Her doctors told her they would “try to prolong her life as long as possible.”

But Quivers sought a second option from doctors in New York at Memorial Sloan Kettering, where she was placed on an aggressive treatment program. By June 2013, Quivers said she was pronounced cancer-free.

Turning point

"We're at a turning point in battling cancer," said CMPI co-founder Robert Goldberg.

But he adds that recent gains are in danger of being lost if there is any let up in efforts to defeat the disease. He says even greater gains in life-years, along with a decline in the cost of treating cancer, are possible through personalized medicine, which reduces the cost and time of treatment compared with the old one-size-fits-all model.

In addition to novel drugs, researchers have also done some outside-the-box thinking when it comes to treatment. In 2012 researchers at Immunocore designed a therapy using the body's 'T-cells to find cancer cells and destroy them, thus harnessing the body's own defenses to beat cancer.

T-cells are a type of lymphocytes – a type of white blood cell – that plays a key role in regulating the body's immune system. On their own T-cells don't do a very good job of distinguishing between healthy or cancerous cells. The Immunocore system basically arms the body's T-cells with a guidance system that helps them target the cancer cells.

Other cancer research is being done at Stanford Medical Center, again focusing on using the body's own tools to destroy cancer.

People with cancer are living longer after being diagnosed with the disease, leading researchers to conclude the world could be cancer-free by the middle o...

Lack of BRCA2 mutations doesn't always mean lower cancer risk

If a woman's family carries the mutation, she may still have a higher risk despite testing negative

Led by celebrities who have undergone so-called prophylactic mastectomies, many women from families with a history of breast cancer have been having genetic tests to determine whether they carry the BRCA2 mutation.

But a new study finds that women who are members of families with BRCA2 mutations but who test negative for the family-specific BRCA2 mutations are still at greater risk for developing breast cancer compared with women in the general population.

The study was published in Cancer Epidemiology, Biomarkers & Prevention, a journal of the American Association for Cancer Research.

Women with certain mutations in their BRCA1 or BRCA2 genes are at increased risk for breast cancer. However, if a woman who comes from a BRCA family tests negative for her family-specific BRCA mutation, her risk for breast cancer is considered to be the same as someone in the general population, according to the National Cancer Institute. This study, however, suggests that it may not always be true.

"We found that women who test negative for family-specific BRCA2 mutations have more than four times the risk for developing breast cancer than the general population," said Gareth R. Evans, honorary professor of medical genetics and cancer epidemiology at the Manchester Academic Health Science Center at the University of Manchester in the United Kingdom. "We also found that any increased risk for breast cancer is largely limited to BRCA2 families with strong family history and other genetic factors.

"It is likely that these women inherit genetic factors other than BRCA-related genes that increase their breast cancer risk," he explained. "About 77 single nucleotide polymorphisms [SNPs—genetic variations that can help track the inheritance of disease genes within families] are linked to breast cancer risk. Identification of additional SNPs is necessary to understand why some of the BRCA-negative women from BRCA families are at higher risk."

The authors note that specialists should use caution when stating that a woman's breast cancer risk is the same as that of the general population following a negative test, because it may not be true for some women who come from BRCA2 families with a strong family history.

Led by celebrities who have undergone so-called prophylactic mastectomies, many women from families with a history of breast cancer have been having geneti...

Assessing the genetic risk of breast cancer

Mutant genes can raise the risk but not as much as other factors

There are many risk factors associated with breast cancer, chief among them is being a woman. After that, age is a factor – as you get older your risk of developing the disease grows.

But since March, when actress Angelina Jolie announced she was undergoing a preventive double mastectomy, the genetic risk factor has gotten a lot of attention. According to the National Cancer Institute (NCI), about 5% to 10% of breast cancers are thought to be hereditary, caused by abnormal genes passed from parent to child.

In most cases of inherited breast cancer two abnormal genes, BRCA1 and BRCA2, are thought to be responsible. The genes themselves aren't abnormal, but can become dangerous when they mutate.

Genes helpful when normal

The function of normal BRCA genes is to repair cell damage and keep breast cells growing normally. But when these genes contain abnormalities or mutations that are passed from generation to generation, the genes don't function normally and breast cancer risk increases.

If testing determines you have an abnormal BRCA gene it doesn't mean you will be diagnosed with breast cancer, though Jolie selected her aggressive option because she was told, in her case, the odds were stacked against her. And just as there are risk factors for cancer itself, there are also risk factors for having a mutant gene. They are:

  • You have blood relatives who were diagnosed with breast cancer before age 50.
  • Someone in your family had both breast and ovarian cancer.
  • Someone in your family had a gland-related cancer, such as pancreatic or colon cancer.
  • There have been women in your family have had cancer in both breasts.
  • You are of Eastern European Jewish heritage.
  • A man in your family had been diagnosed with breast cancer.

Genetic testing

According to NCI, risk increases with the number of affected relatives, age at diagnosis, and the number of affected male relatives. Even if you are unsure of your family health history, there are tests that can reveal a genetic risk of breast cancer.

The test will reveal the presence of an abnormal BRCA1 or BRCA2 gene. Tests can also reveal the presence of other genes that can predispose you toward the illness. If you think you need these tests, you should discuss it with your health care provider.

Jolie chose to have both healthy breasts removed as a measure to prevent what she felt was an extremely high probability she would get breast cancer. That response is not exactly new but is highly effective.

A recent study found that a preemptive mastectomy may reduce breast cancer risk up to 100% if the patient has a strong genetic history of breast cancer or a BRCA mutation. But the level of risk reduction will vary, patient to patient.

Even removing both healthy breasts doesn't always eliminate the risk fully. It is not unheard of for a woman who has undergone a double mastectomy to still develop breast cancer, though it's very rare.

Other risk factors

While it is important to understand and be aware of genetic risks of breast cancer, some breast cancer specialists stress that other, more common risk factors should not be overlooked. According to the National Institutes of Health (NIH), being overweight is a common risk factor. Therefore, a proper diet and maintaining a healthy weight is a strong defense against breast cancer.

Other risk factors include alcohol use. According to the American Cancer Society (ACS), the risk increases with the amount of alcohol consumed. Women who have just one drink a day have a very small increase in risk. Those who have 2 to 5 drinks daily have about 1½ times the risk of women who don’t drink alcohol at all.

Hormone therapy (HT) after menopause has also been linked to an increased risk of breast cancer. ACS cites studies showing the use of combined hormone therapy after menopause increases the risk of getting breast cancer. It may also increase the chances of dying from breast cancer.

This increase in risk can be seen with as little as two years of use. Combined HT also increases the likelihood that the cancer may be found at a more advanced stage. The increased risk appears to apply only to current and recent users. A woman's breast cancer risk seems to return to that of the general population within five years of stopping combined treatment.

There are many risk factors associated with breast cancer, chief among them is being a woman. After that, age is a factor – as you get older your ris...

Women more receptive to preemptive cancer surgery than men

But genetic testing is increasingly important to both sexes

Actress Angelina Jolie's decision to undergo a double mastectomy and have her overies removed made headlines for one simple fact: she is perfectly healthy.

However, she decided to engage in what is called aggressive prevention because she tested positive for a high genetic risk for cancer. Jolie's mother died of breast cancer in her 50s.

This type of preemptive therapy is not exactly new. In 2010 Dr. Susan Domchek of the University of Pennsylvania School of Medicine conducted a large study of women whose genetic make-up -- the presence of what are called BRCA 1 and 2 mutations -- put them at very high risk of cancer.

Domchek found that removing ovaries and breasts not only significantly reduces cancer risks but also increases the odds women will live longer. But she notes this preemptive surgery is not the ideal solution, just a temporary one.

Not a fix

"We shouldn't think these surgical preventions have fixed the problem," she said.

BRCA1 and BRCA2 are human genes that belong to a class of genes known as tumor suppressors. Research has shown that the mutation of these genes is linked to hereditary breast and ovarian cancer. Inheriting the genes can significantly increase the risk of cancer.

A recent study found that a preemptive mastectomy may reduce breast cancer risk up to 100% if the patient has a strong genetic history of breast cancer or a BRCA mutation. But the level of risk reduction will vary, patient to patient.

Even removing both healthy breasts doesn't always eliminate the risk fully. It is not unheard of for a woman who has undergone a double mastectomy to still develop breast cancer, though it's very rare.

Prostate cancer

While men have been known to get breast cancer, a bigger threat to men is prostate cancer. With the headlines full of Jolie's decision, some men took to online health forums to discuss whether men should opt for preemptive prostate removal.

"Since so many men develop this disease at advanced ages why not just remove the prostate as a standard procedure at around the age of sixty?" asked a poster named Roland, at Straightdope.com.

Judging by the replies, that isn't going to happen. In fact, the latest prostate cancer research suggests men might need less treatment for prostate cancer unless they happen to harbor the gene for the most aggressive form of the disease.

Also, removing the prostate gland can have serious and permanent side effects, whereas breast removal seldom causes complications. 

Researchers at the University of California San Francisco are using a new genomic test for prostate cancer that can help predict a man's genetic risk of the most severe form of the disease. But instead of preemptive surgery, they say some men who have been diagnosed with prostate cancer may be able to avoid surgery, and most treatment altogether, if they have what is considered a manageable form of the disease.

Better risk assessment

The test, which improves risk assessment when patients are first diagnosed, can also help in identifying which men are right for active surveillance, which is a way of managing the disease without direct treatment.

An advantage men have is that prostate cancer often grows slowly. Even now, many of the quarter-million patients diagnosed each year in the U.S. never need treatment. Even so, most patients with low-risk prostate cancer immediately undergo treatment, including surgery.

“With the new test, we can more confidently recommend active surveillance when it is appropriate,’’ said the study’s lead author Matthew R. Cooperberg, MD, a UCSF assistant professor of urology and epidemiology & biostatistics. “And patients through active surveillance can avoid or delay surgery or radiation for their condition."

Actress Angelina Jolie's decision to undergo a double mastectomy and have her overies removed made headlines for one simple fact. She is perfectly healthy....

No change in routine mammogram rate despite new guidance

Insurance coverage for annual screenings could be a factor

It appears women in their 40s aren't paying a lot of attention to the latest recommendations for breast cancer screenings.

New research by Johns Hopkins shows they continue to to get mammograms routinely despite national guidelines recommending otherwise.

The U.S. Preventive Services Task Force (USPSTF) sifted through the evidence in 2009 and recommended that women ages 50-74 should continue to undergo mammograms every two years, but that those between 40 and 49 without a family history of breast cancer should discuss the risks and benefits of routine screening mammography with their physicians to make individual decisions.

No changes

Lauren D. Block, M.D., M.P.H., a clinical fellow in the Division of General Internal Medicine at the Johns Hopkins University School of Medicine, and her colleagues expected to find fewer women in their 40s getting routine mammograms. Instead, they found no impact.

"Patients -- and likely their providers -- appear hesitant to change their behavior, even in light of evidence that routine screening in younger women carries substantial risk of false positives and unnecessary further imaging and biopsies," says Block, leader of a study published online in the Journal of General Internal Medicine. "Women have been bombarded with the message 'mammograms save lives,' so they want them no matter what."

Necessary vs. unnecessary

That research has shown that mammography's impact on younger women is mixed at best: routine screening increases rates of detecting cancer in young women, but doesn't reduce mortality risk by all that much.

In fact, studies show it's more likely to result in over-diagnosis, and unnecessary treatment, including biopsies, lumpectomies and mastectomies, and weeks of radiation and potentially toxic drugs. In addition, false positives result in avoidable procedures and psychological trauma, and many of the cancers detected will probably never be dangerous, but are aggressively treated.

Among older women, screening mammograms are recommended because breast cancer -- like most cancer -- is a disease of aging, and a woman's risk of breast cancer increases as she grows older.

Divergence of opinion

The original USPSTF guideline change recommended more forcefully against routine screening for women in their 40s, but a political and advocacy group backlash resulted in compromise language that counseled individual decision-making by patients and physicians. The American Cancer Society still recommends yearly mammography for women starting at age 40.

Moreover, Block says, insurance companies continue to pay for routine mammograms for women in their 40s -- a likely reason for the persistently high rate of screening.

"Breast cancer gets so much attention in the media and in society in general, despite cardiovascular disease being by far the number one killer in women. Everyone wants to feel as though they are preventing breast cancer," Block says. "You hear one anecdotal story about someone in their 40s who found cancer during a mammogram and did really well with treatment and that's enough to fly in the face of any other facts that are out there. Women want the test."  

It appears women in their 40s aren't paying a lot of attention to the new recommendations for breast cancer screenings. New research by John Hopkins shows...

High-fat yogurt, milk, ice cream increase death rate in breast cancer patients

Study looked at the relationship between dairy products and long-term survival rates

Breast cancer patients who eat high-fat dairy products increase their chance of dying from the disease years later, a new study finds.

“Specifically, women consuming one or more servings per day of high-fat dairy had a 64 percent higher risk of dying from any cause and a 49 percent increased risk of dying from their breast cancer during the follow-up period,” said Candyce H. Kroenke, ScD, MPH, staff scientist with the Kaiser Permanente Division of Research.

The category of high-fat dairy products researchers tracked included cream, whole milk, condensed or evaporated milk, pudding, ice cream, custard, flan and also cheeses and yogurts that were not low-fat or non-fat.

The study, published in the Journal of the National Cancer Institute, is the first to examine the relationship between high-fat and low-fat dairy consumption following a diagnosis of breast cancer and long-term breast cancer survival.

Estrogen levels

Previous studies have shown that higher lifetime exposure to estrogen is a  pathway to breast cancer. Estrogen levels are believed to be elevated in dairy products consumed in the Western world, because most of its milk comes from pregnant cows. Estrogenic hormones reside primarily in fat, so levels are higher in high-fat than in low-fat dairy products.

The researchers studied a cohort of women who were diagnosed with early-stage, invasive breast cancer between 1997 and 2000, primarily Northern California and Utah.

Those consuming larger amounts of high-fat dairy (one serving or more per day) had “higher breast cancer mortality as well as higher all-cause mortality and higher non-breast cancer mortality,” Kroenke wrote.

In general, the women studied reported that they consumed low-fat milk and butter most often, and they consumed relatively limited amounts of low-fat dairy desserts, low-fat cheese and high-fat yogurt. Overall, low-fat dairy intake was greater than high-fat dairy.

Switch to low-fat 

The study found an association between high-fat dairy and breast cancer mortality, but no association with low-fat dairy products and breast cancer outcomes.

“High-fat dairy is generally not recommended as part of a healthy diet,” said senior author Bette J. Caan, DrPH, a Kaiser research scientist. “Switching to low-fat dairy is an easy thing to modify.”
Breast cancer patients who eat high-fat dairy products increase their chance of dying from the disease years later, a new study finds.“Specifical...

Advanced breast cancer cases increasing in younger women

Younger women have a poorer prognosis so the findings are cause for concern

In a potentially ominous report, researchers have found "a small but statistically significant" increase in the incidence of advanced breast cancer in younger women in the United States. 

“The trajectory of the incidence trend predicts that an increasing number of young women in the United States will present with metastatic breast cancer in an age group that already has the worst prognosis, no recommended routine screening practice, the least health insurance, and the most potential years of life,” the authors write a study appearing in the February 27 issue of JAMA.

"Young women with breast cancer tend to experience more aggressive disease than older women and have lower survival rates," the researchers noted. 

The study was conducted by Rebecca H. Johnson, M.D., of Seattle Children's Hospital and University of Washington, Seattle, and colleagues, using data from three U.S. National Cancer Institute Surveillance, Epidemiology, and End Results (SEER) registries. 

“In the United States, breast cancer is the most common malignant tumor in adolescent and young adult women 15 to 39 years of age, accounting for 14 percent of all cancer in men and women in the age group. The individual average risk of a woman developing breast cancer in the United States was 1 in 173 by the age of 40 years when assessed in 2008," the article noted. 

Younger not always better

The researchers also found that the rate of increasing incidence of distant disease -- meaning malignancies that had metastisized, or spread to other parts of the body -- was higher in younger women. The greatest increase occurred in 25- to 34-year-old women. Progressively smaller increases occurred in older women by five-year age intervals and no statistically significant incidence increase occurred in any group 55 years or older.

“For young women aged 25 to 39 years, the incidence of distant [metastisized]  disease increased in all races/ethnicities assessed since at least 1992, when race/ethnicity became available in the SEER database,” the authors write. These increases occurred in both metropolitan and nonmetropolitan areas, and were statistically significant in African American and non-Hispanic white populations.

The researchers said the causes for the increase are not known but said more study is needed.

"If verified, the increase is particularly concerning, because young age itself is an independent adverse prognostic factor for breast cancer, and the lowest five-year breast cancer survival rates as a function of age have been reported for 20- to 34-year-old women.

"The most recent national 5-year survival for distant disease for 25- to 39-year-old women is only 31 percent according to SEER data, compared with a 5-year survival rate of 87 percent for women with locoregional breast cancer,” the authors write.

In a potentially ominous report, researchers have found "a small but statistically significant" increase in the incidence of advanced breast cancer in youn...

New Bra Claims to Detect Breast Cancer

Some say it will be a great benefit for early cancer detection, others think not so much

October is Breast Cancer Awareness month, and each year many groups in the United States look to educate people not only about the disease itself, but also how to detect it early.

Lifeline Biotechnologies has licensed a new bra technology called First Warning System (FWS) that it says will assist women in detecting early signs of breast cancer, and the company says the bra will be more responsive and less costly than getting a mammogram.

Lifeline says the FWS can be used either by the OB/GYN or primary care physician, and if the bras test successfully during the trial phase, they could be available for retail purchase by 2014 in the U.S.

That's assuming, of course, that the Food and Drug Administration (FDA) doesn't declare the bra a medical device and require it to undergone rigorous testing, which could slow approval by months or even years. 

Accuracy results

The trial phase for FWS began with 650 women being tested, and the company claims it gave the correct diagnosis 92.1 percent of the time.

Lifeline Biotechnologies said mammograms usually have a 70 percent accuracy reading, and noted proper diagnosis heavily relies on the knowhow of the radiologist. Diagnosis following FWS test results would also rely on the examining physician's knowledge, presumably.

“The goal of the First Warning Breast System is to enhance clinical breast examination aiding in the reduction of superfluous mammograms, needless biopsies and other screening/diagnostic procedures, as well as to develop a physiological profile of the changing breast over time to identify breast tissue abnormalities at their earliest stages,” the company wrote on its website.

The company says the bra works by detecting temperature changes in the breast, which can be a sign of cancer. 

Physicians not sold

But, doctors aren't sold -- either on the idea of the bra or thermography in general. 

“A woman who chooses any breast cancer screening test based on thermography instead of mammography would be making a serious mistake that could have fatal consequences,” said Dr. Ted Gansler of the American Cancer Society in an interview with Fox News. “The main reason is that once these new products are rigorously tested in clinical trials, the result of the study is that they are less effective than current practices.”

However, other medical experts said they believe new methods should be added to breast cancer detection and having the FWS could potentially keep many women from being misdiagnosed. And although the FWS may not be a perfect breast cancer detector, it could be another useful test that backs up mammograms, some believe.

“Hypothetically, it’s conceivable that malignant processes would have a temperature gradient compared to non-malignant tissues,” said Dr. Therese Bevers of the University of Texas in a published interview. “But that gradient may not be very large.”

“We see some thermograms come back as abnormal, and we do all kinds of imaging with mammogram, ultrasound and MRI and we follow the women and nothing develops, and we have women with breast cancers that are not seen on the thermograms,” she said.

"Non-radiogenic"

Lifeline Biotechnologies also says because FWS is non-radiogenic it isn’t toxic, and physicians could immediately start using the bra for breast cancer detection because they wouldn’t require any special or additional training on how to use it. Mammograms are not toxic either, medical authorities note.

If it goes beyond the testing phase, the bra will sell for about $1,000. The company also says the FWS will be somewhat affordable for consumers if it’s ever is sold over the counter, and patients could quickly and easily use the bra for testing, without it taking a lot of time from their day.

October is Breast Cancer Awareness month, and each year many groups in the United States look to educate people not only about the disease itself, but also...

Corporations Issued Guidelines for Breast Cancer Promotions

New York Attorney General pushes for more disclosure to consumers

We're more than halfway through October and the month -- at times -- has been a sea of pink mixed in with fall colors. That's because it's Breast Cancer Awareness Month and everyone from NFL players to retail stores are wrapping themselves in the pink awareness ribbons.

In recent years some companies have been accused of cashing in on the cause, suggesting that a purchase of one product or another would support the cause of breast cancer research. In some cases it was shown little or no money went to a charitable cause.

New York Attorney General Eric Schneiderman has issued a set of “best practices” to promote transparency in charitable “cause marketing” campaigns, which he says is a growing billion-dollar-a-year industry in which companies advertise that the sale or use of a product will result in a charitable contribution.

What does showing a pink ribbon mean?

The standards follow a year-long review of “pink ribbon” and similar campaigns of nearly 150 companies. While these campaigns have resulted in substantial donations, the Attorney General's review found that consumers often do not have sufficient information to understand how their purchases will benefit charity.

“National Breast Cancer Awareness Month continues to increase our understanding of breast cancer and raise funds for the charities fighting it. Consumers who intend to support this worthy cause deserve to know that their purchases do the good promised by the pink ribbon campaigns,” Schneiderman said. “These best practices, agreed to by the nation’s largest breast cancer charities, will help ensure that cause marketing campaigns provide the benefit that’s expected, and that consumers, charities, and above all, the women and families affected by this devastating disease are protected.”

Key information

The best practices require companies clearly and prominently disclose key information about each campaign, including the specific amount that will be donated to charity from each purchase. Companies using ribbons and similar symbols on products must make clear to consumers if a purchase will trigger a donation, or if the symbols are used merely for awareness of a cause.

The best practices are also designed to ensure more transparency in social media campaigns, in which companies promise donations if consumers agree to “like” or “follow” them or their products. Schneiderman said the nation's two largest breast cancer charities, Susan G. Komen For The Cure and Breast Cancer Research Foundation, are showing their commitment to transparency by adopting the best practices.

“Our office commends Susan G. Komen For The Cure and Breast Cancer Research Foundation for signing onto these best practices, and leading the industry to greater transparency and accountability,” Schneiderman said. “These guidelines will bolster public confidence in cause marketing and hopefully will result in more money going to fighting this horrible disease.”

The five-point best practices are:

  • Clearly Describe the Promotion
  • Allow Consumers to Easily Determine Donation Amount
  • Be Transparent About What Is Not Apparent
  • Ensure Transparency in Social Media
  • Tell the Public How Much Was Raised
We're more than halfway through October and the month, at times, has been a sea of pink mixed in with fall colors. That's because it's Breast Cancer Awaren...

New Treatment Approved for Advanced Colorectal Cancer

The new med adds more than six months to life expectancy

Patients with colorectal cancer that has progressed after treatment and spread to other parts of the body (metastatic) have a new treatment option. 

The U.S. Food and Drug Administration (FDA) has approved Stivarga (regorafenib), a multi-kinase inhibitor that blocks several enzymes that promote cancer growth. The drug was reviewed under the FDA’s priority review program that provides an expedited six-month review for drugs that offer major advances in treatment or that provide treatment when no adequate therapy exists. 

Stivarga was approved one month ahead of the product’s prescription drug user fee goal date of Oct. 27, 2012, the date the agency was scheduled to complete review of the drug application. 

Life-extending properties 

“Stivarga is the latest colorectal cancer treatment to demonstrate an ability to extend patients’ lives and is the second drug approved for patients with colorectal cancer in the past two months,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research. 

The safety and effectiveness of Stivarga were evaluated in a single clinical study of 760 patients with previously treated metastatic colorectal cancer. Patients were randomly assigned to receive Stivarga or placebo in addition to best supportive care (BSC), which includes treatments to help manage side effects and symptoms of cancer. Patients received treatment until their cancers progressed or side effects became unacceptable. 

Study results showed patients treated with Stivarga plus BSC lived a median of 6.4 months compared to a median of five months in patients treated with placebo plus BSC. Results also showed patients treated with Stivarga plus BSC experienced a delay in tumor growth (progression-free survival) for a median of two months compared to a median of 1.7 months in patients receiving placebo plus BSC. 

Side effects outlined 

Stivarga is being approved with a Boxed Warning alerting patients and health care professionals that severe and fatal liver toxicity occurred in patients treated with Stivarga during clinical studies. The most common side effects reported in patients treated with Stivarga include weakness or fatigue, loss of appetite, hand-foot syndrome (also called palmar-plantar erythrodysesthesia), diarrhea, mouth sores (mucositis), weight loss, infection, high blood pressure, and changes in voice volume or quality (dysphonia). 

In August 2012, the FDA approved Zaltrap (ziv-aflibercept) for use in combination with a FOLFIRI (folinic acid, fluorouracil and irinotecan) chemotherapy regimen to treat adults with metastatic colorectal cancer. 

According to the Centers for Disease Control and Prevention, colorectal cancer is the third most common cancer in men and in women and the third leading cause of cancer death in men and in women in the United States. The National Institutes of Health estimates 143,460 people in the U.S will be diagnosed with colorectal cancer, and 51,690 will die from the disease this year. 

Stivarga is marketed by Bayer HealthCare Pharmaceuticals, based in Wayne, N.J. Zaltrap is marketed by Bridgewater, N.J.-based sanofi-aventis.

Patients with colorectal cancer that has progressed after treatment and spread to other parts of the body (metastatic) have a new treatment option....

Zaltrap Approved for Colorectal Cancer Treatment

The addition of the biological agent to chemotherapy increases survival time

The U.S. Food and Drug Administration (FDA) has approved Zaltrap (ziv-aflibercept) for use in combination with a FOLFIRI (folinic acid, fluorouracil and irinotecan) chemotherapy regimen to treat adults with colorectal cancer. 

Zaltrap is an angiogenesis inhibitor that inhibits the blood supply to tumors. It is intended for patients whose cancer has spread to other parts of the body (metastatic) and whose tumors are resistant to or progressed after a chemotherapy regimen that includes oxaliplatin. 

“This approval demonstrates the benefits of adding a biological agent, Zaltrap, to a commonly used chemotherapy drug regimen, FOLFIRI,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “An improvement in median survival time was noted with the addition of Zaltrap to FOLFIRI, accompanied by an improvement in response rate and a delay in tumor progression and growth.” 

Zaltrap’s safety and effectiveness was evaluated in a randomized clinical study of 1,226 patients with metastatic colorectal cancer whose cancer grew while receiving oxaliplatin-based combination chemotherapy, or whose cancer was removed by surgery but returned within six months after receiving oxaliplatin-based combination chemotherapy for post-surgery (adjuvant) treatment. Participants received treatment until their cancer progressed or side effects became unacceptable. 

Improved survival time 

The study was designed to measure overall survival, or the length of time a patient lived.  Patients who were assigned to receive the Zaltrap plus FOLFIRI combination lived an average of 13.5 months compared to an average of 12 months for those receiving FOLFIRI plus placebo. 

A reduction in tumor size occurred in 20 percent of patients receiving the Zaltrap plus FOLFIRI combination versus 11 percent for those receiving FOLFIRI plus placebo. 

In addition, the clinical trial demonstrated an improvement in progression-free survival, or the time a patient lived without the cancer progressing. The progression-free survival for patients receiving the Zaltrap plus FOLFIRI combination was 6.9 months compared with 4.7 months for those receiving FOLFIRI plus placebo. 

Boxed warning included 

Zaltrap is being approved with a Boxed Warning alerting patients and health care professionals that the drug can cause severe and sometimes fatal bleeding, including gastrointestinal bleeding, and the development of holes in the gastrointestinal tract. Zaltrap can also make it more difficult for wounds to heal. 

The most common side effects observed in patients receiving Zaltrap plus FOLFIRI were decreased white blood cell count, diarrhea, mouth ulcers, fatigue, high blood pressure, increased amount of protein in the urine, weight loss, decreased appetite, abdominal pain, and headache. 

Colorectal cancer is the fourth most commonly diagnosed cancer and the fourth leading cause of cancer death in the United States. According to the National Institutes for Health, an estimated 143,460 Americans will be diagnosed with colorectal cancer and 51,690 will die from the disease in 2012.

The U.S. Food and Drug Administration has approved Zaltrap (ziv-aflibercept) for use in combination with a FOLFIRI (folinic acid, fluorouracil and irinotec...

FDA Approves Afinitor for Advanced Breast Cancer Treatment

The treatment with a new drug combo delays progression of the disease

A new drug combination for treatment of breast cancer will soon be on the market. 

The U.S. Food and Drug Administration (FDA) has approved Afinitor (everolimus) for use in combination with Aromasin (exemestane) to treat certain postmenopausal women with advanced hormone-receptor positive, HER2-negative breast cancer. 

The drug combination is intended for use in women with recurrence or progression of their cancer after treatment with Femara (letrozole) or Arimidex (anastrozole). 

“This is the first approval from the class of drugs known as mTOR inhibitors for the treatment of postmenopausal women with advanced hormone-receptor positive breast cancer,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Afinitor is another example of the value of continuing to study drugs in additional types of cancer after their initial approval.” 

Breast cancer is the second leading cause of cancer-related death among women. An estimated 226,870 women will be diagnosed with breast cancer this year, and 39,510 will die from the disease. 

Rigorous testing 

The safety and effectiveness of Afinitor was evaluated in a clinical study of 724 patients with advanced breast cancer. All patients had experienced menopause, had estrogen receptor-positive, HER2-negative breast cancer that had spread, and had previously received treatment with Femara or Arimidex. 

Patients were selected to receive either Afinitor in combination with Aromasin or Aromasin with a placebo (sugar pill). Patients received treatment until their cancers progressed or side effects became unacceptable. 

The study was designed to measure the length of time a patient lived without the cancer progressing, or progression-free survival (PFS). Patients who were assigned to receive Afinitor plus Aromasin combination had a 4.6 month improvement in the median time to disease progression or death compared to patients receiving the placebo plus Aromasin. 

The most common side effects observed in patients receiving Afinitor for breast cancer were mouth ulcers, infections, rash, fatigue, diarrhea and decreased appetite. Patients aged 65 years and older should be monitored closely as these patients experience a higher rate of serious side effects than younger patients receiving the treatment. 

Other uses 

The FDA has previously approved Afinitor to treat patients with advanced renal cell carcinoma that has progressed after treatment with other cancer therapies, in adult patients with progressive advanced neuroendocrine tumors of pancreatic origin, for patients with renal angiomyolipoma and tuberous sclerosis complex (TSC) not requiring immediate surgery, and for adults and children with subependymal giant cell astrocytoma associated with TSC who require treatment but are not candidates for curative surgery. 

Afinitor is marketed by East Hanover, N.J.-based Novartis Pharmaceuticals Corporation.

The U.S. Food and Drug Administration (FDA) has approved Afinitor (everolimus) for use in combination with Aromasin (exemestane) to treat certain postmenop...

FDA Removes Breast Cancer Treatment Approval From Avastin

Drug can still be used to treat colon cancer

In what was probably a foregone conclusion, the U.S. Food and Drug Administration (FDA) has ruled the the cancer drug Avastin should not be used to treat breast cancer because there is no evidence that it is effective.

The drug remains on the market, since it is used primarily to treat colon cancer. It is still approved for that use.

Many breast cancer parients will likely be disappointed with the ruling, but FDA Commissioner Margaret Hamburg said the decision, though difficult, was necessary because patients have to have confidence the medication they are taking is effective.

Move not unexpected

As expected, the FDA took the advice of its panel of experts that studied the drug and its use to treat breast cancer. In June the panel recommended that Avastin not be used for breast cancer.

The ruling came in spite of strong pleas from breast cancer patients and Genentech, the pharmaceutical company that makes the drug. However, panel members said at the time that clinical trials simply failed to bear out the early promise for the drug.

Though Avastin will remain on the market, Genentech will no longer be allowed to market it as a breast cancer treatment. More importantly, insurance companies will no longer pay for it to treat breast cancer. The drug costs about $88,000 a year to treat one patient.

Last December FDA recommended removal of the breast cancer indication from the label for Avastin because it said the drug has not been shown to be safe and effective for that use.

The recommendation followed a review of the results of four clinical studies of Avastin in women with breast cancer and a determination that the data indicate that the drug does not prolong overall survival in breast cancer patients or provide a sufficient benefit in slowing disease progression to outweigh the significant risk to patients.

These risks include severe high blood pressure; bleeding and hemorrhage; the development of perforations (or "holes") in the body, including in the nose, stomach, and intestines; and heart attack or heart failure.

FDA has removed approval for Avastin to treat breast cancer...

Sham Breast Cancer Charity Organizers Plead Guilty

Money raised to fight breast cancer was spent on personal shopping and travel

Two guilty pleas were entered in a New York courtroom today in connection with a fundraising scheme that concocted a bogus charity, raised and then stole more than $500,000 of donations intended to fight breast cancer, New York Attorney General Eric T. Schneiderman announced.

David Winston pleaded guilty to two felony charges related to the operation of the phony charity, Coalition for Breast Cancer Cures, Inc, and a for-profit fundraising arm, The Resource Center, which funneled donations to pay for extravagant travel, shopping and other personal living expenses.

His wife, Mindy Winston, pleaded guilty to one felony charge related to falsifying business records, specifically, a bank account for the sham charity.

Lavish lifestyle

“The Winstons supported a lavish lifestyle by using the hard-earned money donors gave to fight breast cancer,” Schneiderman said. “My office has no tolerance for this kind of exploitation, and we will hold accountable anyone who takes advantage of New Yorkers’ generosity and sympathies.”

David and Mindy Winston surrendered and appeared before the Acting County Court Judge for Nassau County, the Honorable Francis Ricigliano. David Winston pleaded guilty to one count of grand larceny, a Class D felony, and one count of scheme to defraud, a Class E felony, under a plea agreement. He will be sentenced at a later date to a term between 2 and 6 years. Mindy Winston pleaded guilty to one count of falsifying business record, a Class E felony, under a plea agreement. She will receive probation.

The Attorney General’s Office first filed a civil lawsuit against the Long Island-based fake charity in April 2010. The lawsuit alleged that the Winstons diverted more than $500,000 donated to fight breast cancer to pay for extravagant travel, shopping, and other personal living expenses. Some of the unlawful expenditures the Attorney General’s Office uncovered include:

  • Over $3,700 in personal hotel and airfare expenses;
  • Over $5,000 at restaurants including Peter Luger Steakhouse, Caesars Palace Mesa Grill, and Gotham Bar and Grill;
  • Over $7,700 in retail purchases at stores such as Louis Vuitton, Victoria’s Secret, Home Depot, Best Buy, Costco, CVS, Loehmann’s, and Target;
  • Over $8,000 for their daughter’s sorority dues and other university expenses and fees;
  • Over $1,300 for a spring break travel package;
  • Thousands of dollars on groceries, Netflix, and cable television.

The civil lawsuit, which is still pending, also alleged that the Winstons falsely claimed that the Coalition for Breast Cancer Cures was a registered nonprofit, mailed phony invoices to dupe donors, and repeatedly charged donors’ credit cards without authorization.

The Coalition for Breast Cancer Cures did not register with the Attorney General as a charitable organization and the Resource Center did not register with the Attorney General as a professional fundraiser, as required by law.

Two guilty pleas were entered in a New York courtroom today in connection with a fundraising scheme that concocted a bogus charity, raised and then stole m...

Are Companies Cashing In On Breast Cancer?

Researchers accuse some firms of 'pinkwashing'

Last week the New York Attorney General filed suit against a group called the Coalition Against Breast Cancer, branding it a “sham charity.” It's a more extreme example of a corporate trend researchers call “pinkwashing.”

According to Amy Lubitow, Portland State University (Oregon), and Mia Davis, Campaign for Safe Cosmetics, “pinkwashing” describes the practice of companies adopting pink colors and ribbons to imply they support breast cancer research, while at the same time permitting the use of chemicals shown to cause cancer.

The concern is not exactly new, but the rhetoric is sharpening. In very strong words, Lubitow and Davis accuse such companies of “committing a form of social injustice against women.” The two have co-authored an article on “pinkwashing” in the journal Environmental Justice.

The authors say that aligning oneself with a cause such as breast cancer, while carrying out research, manufacturing, or other types of policies or processes that involve the use of chemicals with a proven link to cancer crosses a critical line between just and unjust practices.

Pure profit motive?

They accuse companies that “pinkwash” with being motivated solely by the profit motive. These companies, they say, link themselves to the cause to increase profits but are taking actions and pursing policies that might contribute to higher cancer rates.

Last year, the company marketing an alcoholic lemonade product came in for some criticism for its campaign to “pink your drink,” a way the marketers said people could promote breast cancer year round.

Breast cancer awareness and breast cancer research have become enormously popular causes in recent years, with hundreds of businesses and organizations joining the effort to fight the disease. October, the official breast cancer awareness month, is usually marked by a sea of pink, as these organizations, most of whom sincerely and wholeheartedly support the effort, show pink.

Real men wear pink

For example, the National Football League observes the month by having players wear pink accessories, like gloves and shoes, along with their normal team colors. These efforts have won praise for raising the profile of breast cancer awareness, though some in the movement wondered aloud last year if they weren't getting just a bit over-exposed.

Those in the movement are also concerned about the trend Lubitow and Davis highlight in their article, claiming too many companies are simply trying to cash in on the good feelings.

"The authors of this article draw needed attention to the dangerous use of consumers' social and sometimes environmental consciousness by institutions who contribute to environmental health disparities,”said Sylvia Hood Washington, PhD, ND, MSE, MPH, Editor-in-Chief of Environmental Justice, and Research Associate Professor at the University of Illinois at Chicago School of Public Health. “The blind financial support of these entities, by affected consumers, is a form of environmental injustice that is clearly elucidated by the authors.'

In other words, breast cancer awareness groups would like consumers to think carefully about the product they buy, and not choose it just because it has a pink label. 

Everyone seems to want to support breast cancer awareness, and maybe that's not so good...

Coalition Against Breast Cancer a 'Sham," New York Charges

$9.1 million in public donations has been squandered, lawsuit alleges

The Coalition Against Breast Cancer (CABC) is "a sham charity that has diverted nearly all of the millions of dollars raised in the name of breast cancer to its officers, directors and fund raisers," the New York attorney general says.  

In a lawsuit, attorney general Eric Schneiderman suit says the coalition falsely claims to be affiliated with major hospitals including Memorial Sloan-Kettering and says it uses “other lies and deceptions” to bilk donors who think their contributions will go to fight breast cancer.

In reality, the suit says, the coalition “spends none of its funds on eradicating breast cancer” and has no affiliation with any major hospital or research organization.

$9 million 'squandered'

The suit says that in the last five years, during which 200,000 women died from breast cancer, the coalition has “squandered and misused virtually all of the $9.1 million it raised,” spending less than 4% of its donations on any kind of charitable program.

In 2008, the suit says CABC raised $1.4 million from the public but spent only $374 for mammograms.

In the past three years, despite raising more than $4 million, the coalition has funded only 11 mammograms, the suit alleges.

“In short, Defendants have misused and wasted millions of charitable dollars that could have been used to treat and potentially save an untold number of breast cancer victims,” the suit charges.

The suit says that CABC founders Andrew Smith and Garrett Morgan launched CABC in 1995 when they were both short of cash. Smith was emerging from bankruptcy and Morgan was being investigated for his role in a fraudulent meals-on-wheels charity, Schneiderman alleges.

The suit quotes a February 2010 email from Smith to Morgan as summarizing the duo's attitude: “We are in a bad place. You need the money and so do I.”

 

 

The Coalition Against Breast Cancer (CABC) is "a sham charity that has diverted nearly all of the millions of dollars raised in the name of breast cancer t...

Arthritis 'Miracle' Drug Caused Breast Cancer, Suit Charges

Abbott Labs accused of not adequately warning Humira users

A woman claims that 5 years of bimonthly injections of Abbott Laboratories' Humira, a "blockbuster" arthritis drug, caused her breast cancer. 

In a case filed in U.S. District Court in Boston, Maureen Calisi says she began taking the drug in late 2003 and continued taking it through February 2008. She was later diagnosed with breast cancer.

The suit charges that Abbott labs failed to provide adequate warning of the drug's cancer risks and that the injections of Humira caused her cancer.

The lawsuit says that Humira is a “biologic” drug, which means that it is a medicine that has been constituted or reconstituted from natural substances in the body. Launched in 2003 for the treatment of rheumatoid arthritis, it was the first such drug in its class that was derived from actual human cells.

TNF

Humira is believed to bind specifically to Tumor Necrosis Factor (TNF), a naturally occurring substance in the human body that is related to the workings of the body"s immune system. Humira blocks TNF's interaction with certain cell surface receptors, thereby interfering with TNF activity.

TNF blocks have been heralded as a “miracle” drug for rheumatoid arthritis but Calisi's suit charges that Abbott has downplayed the risk of side effects, including the development of lymphoma and other forms of cancer.

Humira has been approved in 83 countries and is currently being used to treat nearly 500,000 patients worldwide, generating revenue of about $6.5 billion, according to published reports.

Clinical trials

The suit charges that during clinical trials prior to the drug's 2002 approval, a number of the 2,070 patients on whom it was tested developed lymphoma and other cancers.

While the cause of cancer is generally elusive, the suit claims that the rate of cancer was higher in those patients who receive Humira than in patients who received a placebo.

By the close of 2003, when Humira was prescribed for Calisi, there were a total of 365 serious adverse event reports in the FDA database. Of the 365 serious reports, 25 – or 7% – involved some form of malignancy. This should have put Abbott on notice that it needed to issue a stronger warning, the suit argues.

But, the suit says, Abbott did nothing to warn patients directly until the FDA required it to do so in 2009.

In February 2008, Calisi discovered a lump in her breast that was subsequently identified as a primary diffuse large B-cell lymphoma of the breast. She immediately stopping taking Humira and her cancer is now in remission.

 

Arthritis 'Miracle' Drug Caused Breast Cancer, Suit Charges. Abbott Labs accused of not adequately warning Humira users...

New AstraZeneca Thyroid Cancer Drug Approved

Vandetanib treats patients who aren't eligible for surgery

The U.S. Food and Drug Administration today approved vandetanib, a new drug for adult patients with late-stage medullary thyroid cancer who are ineligible for surgery and who have disease that is growing or causing symptoms.

Vandetanib targets medullary thyroid cancer’s ability to grow and expand. There are currently no FDA-approved treatments for this type of cancer. Vandetanib is administered orally on a daily basis.

Vandetanib’s safety and effectiveness were established in a single, randomized international study of 331 patients with late-stage medullary thyroid cancer. Patients in the study were selected to receive vandetanib or placebo (sugar pill).

The study was designed to measure the length of time a patient lived without the individual’s cancer progressing. Patients who received vandetanib had a longer period of time without disease progression when compared to patients receiving placebo.

Common side effects occurring from vandetanib use include diarrhea, rash, nausea, high blood pressure, headache, fatigue, decreased appetite, and stomach (abdominal) pain. Serious side effects reported during the study resulted in five deaths in patients treated with vandetanib. Causes of death included breathing complications, heart failure, and a bacterial infection in the blood.

Vandetanib was shown to affect the electrical activity of the heart, which in some cases can cause irregular heart beats that could lead to death. Vandetanib is being approved with a Risk Evaluation and Mitigation Strategy (REMS) to inform health care professionals about these serious heart-related risks.

Thyroid cancer is a cancerous growth of the thyroid gland, which is located in the neck. Medullary thyroid cancer involves specific types of cells that are found in the thyroid gland and can occur spontaneously, or be part of a genetic syndrome.

About 44,600 new thyroid cancer cases were diagnosed in the United States during 2010, and about 1,690 people died from the disease, according to the National Cancer Institute. Medullary thyroid cancer is estimated to represent 3 to 5 percent of all thyroid cancer; its estimated incidence in the United States for 2010 is about 1,300 to 2,200 patients, making it one of the rarer forms of thyroid cancer.

Common symptoms of medullary thyroid cancer may include coughing, difficulty swallowing, enlargement of the thyroid gland, swelling of the neck, a lump on the thyroid, and changes in a person’s voice or hoarseness.

 

New AstraZeneca Thyroid Cancer Drug Approved. Vandetanib treats patients who aren't eligible for surgery...

FDA Approves New Drug to Treat Advanced Melanoma

Drug lengthened survival time for skin cancer patients tested

The U.S. Food and Drug Administration (FDA) today approved a new drug for patients with late-stage melanoma, the most dangerous type of skin cancer.

Yervoy (ipilimumab) is a monoclonal antibody that blocks a molecule known as CTLA-4, which is thought to play a role in slowing down or turning off the body’s immune system, affecting its ability to fight off cancerous cells.

Yervoy, developed by Bristol-Myers Squibb Co., will initially be sold only for use in patients who have not responded to other treatments. The drug is administered intravenously.

Melanoma is the leading cause of death from skin disease. An estimated 68,130 new cases of melanoma were diagnosed in the United States during 2010 and about 8,700 people died from the disease, according to the National Cancer Institute.

“Late-stage melanoma is devastating, with very few treatment options for patients, none of which previously prolonged a patient’s life,” said Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research. "Yervoy is the first therapy approved by the FDA to clearly demonstrate that patients with metastatic melanoma live longer by taking this treatment."

Patients lived longer

Yervoy’s safety and effectiveness were established in a single international study of 676 patients with melanoma. All patients in the study had stopped responding to other FDA-approved or commonly used treatments for melanoma. In addition, participants had disease that had spread or that could not be surgically removed. 

The study was designed to measure overall survival, the length of time from when the treatment started until a patient's death. The randomly assigned patients received Yervoy plus an experimental tumor vaccine called gp100, Yervoy alone, or the vaccine alone.

 Those who received the combination of Yervoy plus the vaccine or Yervoy alone lived an average of about 10 months, while those who received only the experimental vaccine lived an average of 6.5 months.

While those benefits may appear modest, scientists say some people who took the drug several years ago when it was still in the early testing stages are still alive today.

"I think the vast majority of patients with metastatic melanoma should at some point try this agent," said Patrick Hwu, chairman of the department of melanoma medical oncology at the University of Texas MD Anderson Cancer Center in Houston.

Side effects

The drug can have severe side effects, including fatigue, diarrhea, skin rash, endocrine deficiencies (gland or hormone), and inflammation of the intestines (colitis). Severe to fatal autoimmune reactions were seen in 12.9 percent of patients treated with Yervoy. 

When severe side effects occurred, Yervoy was stopped and corticosteroid treatment was started. Not all patients responded to this treatment. Patients who did respond in some cases did not see any improvement for several weeks.

Due to the unusual and severe side effects associated with Yervoy, the therapy is being approved with a Risk Evaluation and Mitigation Strategy to inform health care professionals about these serious risks. A medication guide will also be provided to patients to inform them about the therapy's potential side effects, the FDA said.

 

 

FDA Approves New Drug to Treat Advanced Melanoma. Drug lengthened survival time for skin cancer patients tested ...

FDA Announces Approval of 3-D Mammogram Imaging

3-D images could help make detecting and diagnosing cancer easier for doctors

The U.S. Food and Drug Administration today approved the Selenia Dimensions System, the first X-ray mammography device that provides three-dimensional (3-D) images of the breast for breast cancer screening and diagnosis.

The 3-D images may help physicians more accurately detect and diagnose breast cancer.

Currently, mammograms take safe, low-dose, two dimensional (2-D) X-ray images of the breast and is the best tool for early detection of breast cancer because it can reveal tumors even when the patient has no symptoms.

However, with the limitations of conventional 2-D imaging, about 10 percent of women undergo additional testing after the initial screening exam for abnormalities that are later determined to be noncancerous.

The Selenia Dimensions System, an upgrade to Hologic’s existing FDA-approved 2-D system, can provide both 2-D and 3-D X-ray images of the breasts.

“Physicians can now access this unique and innovative 3-D technology that could significantly enhance existing diagnosis and treatment approaches,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.

40 million  

The National Cancer Institute recommends women ages 40 and older have a mammogram every one to two years. Nearly 40 million mammograms are performed each year in the United States.

As part of the approval process, the FDA reviewed results from two studies where board-certified radiologists were asked to review 2-D and 3-D images from more than 300 mammography exams.

In both studies, radiologists viewing both the 2-D and 3-D images obtained a 7 percent improvement in their ability to distinguish between cancerous and non-cancerous cases as compared to viewing 2-D images alone.

While the combination of the Selenia’s 2-D and 3-D images approximately doubled the radiation dose the patient received, it improved the accuracy with which radiologists detected cancers, decreasing the number of women recalled for a diagnostic workup.

There is uncertainty for radiation risk estimates; however, the increase in cancer risk from having both a 2-D and 3-D exam is expected to be less than 1.5 percent compared to the natural cancer incidence, and less than 1 percent compared to the risk from conventional 2-D mammography.

According to the NCI, nearly 200,000 women will be diagnosed with breast cancer this year. And 1 in 8 women will be diagnosed with breast cancer during their lifetime.

There is a 98 percent survival rate when breast cancer is detected early and still localized to the breast.

FDA Announces Approval of 3-D Mammogram Imaging 3-D images could help make detecting and diagnosing cancer easier for doctors...

Breast Cancer Groups Denounce Alcoholic Beverage 'Partners'

Companies deny they're trying to capitalize on cancer cure efforts

October is Breast Cancer Awareness Month and hundreds of businesses and organizations are lending their support to publicize efforts to find a cure.

But not all that support is welcome. When alcoholic beverage companies take up the cause, it raises eyebrows.

Mike's Hard Lemonade now comes in a pink variety to promote the cause. And Chambord, which markets pink vodka and liqueurs, urges people to "pink their drink," saying that "by adding a splash of Chambord to any cocktail, you're supporting breast cancer awareness year-round."

But some breast cancer survivors aren't happy, saying it's hypocritical to raise money for research while selling a product that contributes to the disease.

Both the American Cancer Society and the National Cancer Institute say even moderate drinking increases breast cancer risk.

"Anybody trying to sell alcohol to promote breast cancer awareness should be ashamed of themselves," said Barbara Brenner, executive director of Breast Cancer Action, an advocacy group.

Chambord's website notes that its Pink Your Drink campaign has raised more than $50,000 in donations for the Breast Cancer Network of Strength and other patient groups.

Mike's Hard Lemonade has given $500,000 over the past two years to the Breast Cancer Research Foundation, company president Phil O'Neil says. The company was inspired by the loss of an employee named Jacqueline who died after a long battle with breast cancer.

"The donations we make to breast cancer research are not tied to sales; they are our way of honoring Jacqueline," O'Neil said in a statement.

But in many cases, cause-related marketing is not about charity, said Dwight Burlingame, associate executive director of the Center on Philanthropy at Indiana University.

"These businesses are promoting their product," he said.

At least one breast cancer charity is walking away from alcohol-related gifts.

"We have a partnership with alcohol, and I don't understand it, either," said Cindy Geoghegan, the new interim CEO at Breast Cancer Network for Strength. "Those kinds of relationships will not continue."

And though the Breast Cancer Research Foundation said it appreciates donations from Mike's Hard Lemonade, spokeswoman Anna DeLuca says, the group "in no way, shape or form endorses the consumption of alcohol."

"This donation does not constitute a partnership," DeLuca said.

Hundreds of businesses and organizations are lending their support to publicize efforts to find a cure...

Household Cleaning Products May Play Role in Breast Cancer

Study of Massachusetts women finds high use of cleaning products doubles breast cancer risk

By Mark Huffman
ConsumerAffairs.com

July 20, 2010

Being a fastidious housekeeper may not be without its risks. A study published in the international journal Environmental Health found that women who used the most household cleaning products had double the rate of breast cancer as those who used the fewer cleaners.

Researchers conducted telephone interviews with 787 Masachusetts breast cancer patients aged 60 to 80 years old in Massachusetts, and compared them to 721 women who did not have breast cancer.

"Women who reported the highest combined cleaning product use had a doubled risk of breast cancer compared to those with the lowest reported use," said study leader Dr Julia Brody, of the Silent Spring Institute in Newton, Mass. "Use of air fresheners and products for mold and mildew control were associated with increased risk. To our knowledge, this is the first published report on cleaning product use and risk of breast cancer."

Many pesticides, household cleaners and air fresheners contain ingredients known to trigger breast cancer in animals, said the researchers. Some also contain endocrine disrupting chemicals (EDCs) that could theoretically affect the growth of estrogen-sensitive breast cells.

Hormone-disruptors such as synthetic musks and phthalates were commonly used in air fresheners, said the scientists. Air fresheners may also contain chemicals called terpenes which can react with ozone in the air to form cancer triggers such as formaldehyde, benzene and styrene, they added.

"Although exposure levels may be low and EDCs are typically less potent than endogenous hormones, limited knowledge of product formulations, exposure levels and the biological activity and toxicity of chemical constituents alone and in combination make it difficult to assess risks associated with product use," the researchers wrote.

The scientists acknowledged that their results might be swayed by "recall bias" because they depended on answers to questions about activities in the women's past; they called for more extensive research into the question.

"Because exposure to chemicals from household cleaning products is a biologically plausible cause of breast cancer and avoidable, associations reported here should be further examined prospectively," the researchers concluded.

Industry objects

Not surprisingly, the makers of household cleaning products were unhappy with the study. The American Cleaning Institute (ACI) calls the study questionable and said it "overreaches in its conclusions."

"Simply put, this research is rife with innuendo and speculation about the safety of cleaning products and their ingredients," said Richard Sedlak, ACI's Senior Vice President of Technical and International Affairs. "This is all based on the most cursory look at the scientific literature and the recollection of breast cancer survivors as to the products they used 15 to 20 years ago."

"Unfortunately, this work sheds little light on the real causes of breast cancer," he said.



Household Cleaning Products May Play Role in Breast Cancer...

Breast Cancer Lawsuit Alleged Needless Suffering, Death

$17.5 million settlement reached in Newfoundland, Labrador suit

A $17.5 million preliminary settlement has been reached in a lawsuit alleging severe flaws in a Canadian health care provider's breast cancer screening. Hormone receptor tests administered by Eastern Health Corp. returned scores of incorrect results over an eight-year period, leading to needlessly harsh treatment for hundreds of breast cancer patients, and may have contributed to over a hundred deaths.

The deal between Eastern Health Corp. and breast cancer patients in the Canadian provinces of Newfoundland and Labrador came after three days of mediation supervised by a former Ontario judge.

Doctors routinely order hormone receptor tests for newly-diagnosed breast cancer sufferers, and use them to determine the best course of treatment. Patients with tumors that test positive for estrogen and progesterone generally have a better prognosis, partly because such tumors grow more slowly.

Additionally, patients whose tumors are being strengthened by estrogen and progesterone can be treated with anti-estrogen prescription drugs, such as Tamoxifen and Anastrozole. Patients with negative test results generally have to resort to far harsher treatments, including chemotherapy and radiation.

According to the suit, at least 425 breast cancer patients were given incorrect hormone test results between 1997 and 2005. A number of these patients underwent chemotherapy and surgery even though their cancer could likely have been treated with anti-estrogen drugs. The suit was brought on behalf of approximately 2,000 patients tested during the relevant period.

Over 100 patients who received incorrect results have died. While it's impossible to say that hormone testing would have saved their lives, it's a possibility that's hard to ignore.

In addition to the $17.5 million, the settlement mandates the creation of a panel to implement recommended changes to Eastern Health's breast cancer protocol. Under the terms of the agreement, victims of Eastern Health's botched tests will be given seats on the committee and a consultant will give a report on the panel's progress in 2012. Eastern Health is also required to construct a memorial and issue a public apology.

Eastern Regional Integrated Health Authority CEO Vicki Kaminski immediately broadcast that apology. The class members are sincere, honest people who have been wronged and harmed, and this settlement is meant as a sincere apology to them, Kaminski said in a statement. She added that no amount of money can adequately compensate people who have experienced this kind of error in their medical treatment.

How the money will be disbursed, and how much will be picked up by Eastern Health insurer Healthcare Insurance Reciprocal of Canada, won't be announced until the settlement is formally approved by the Supreme Court of Newfoundland and Labrador.

Eastern Health describes itself as the largest integrated health authority in Newfoundland and Labrador, the coastal province in northeastern Canada.

 



Breast Cancer Lawsuit Alleged Needless Suffering, Death...

FDA Approves Lung Cancer Drug

Offers new approach to treatment

The Food and Drug Administration (FDA) has approved Alimta (pemetrexed), the first drug available for maintenance therapy of advanced or metastatic lung cancer.

Patients with cancer often receive maintenance therapy to prevent the disease from progressing after their tumor has shrunk or the disease has stabilized in response to chemotherapy. Alimta disrupts metabolic processes that are dependent on the B-vitamin folate, a necessary ingredient for cell reproduction.

"This drug represents a new approach in the treatment of advanced non-small cell lung cancer," said Richard Pazdur, M.D., director, Office of Oncology Drug Products in the FDA's Center for Drug Evaluation and Research. "Typically, patients whose tumors respond to chemotherapy do not receive further treatment after four-to-six chemotherapy cycles. This study demonstrates an advantage in overall survival in certain patients who received Alimta for maintenance therapy.

Non-small cell lung cancer has several subtypes, including squamous cell, large cell, adenocarcinoma and mixed histology cancers. In a 600-patient clinical trial, people with predominantly squamous cell cancer did not benefit from Alimta.

But those with other subtypes of non-small lung cancer survived an average 15.5 months following treatment compared with 10.3 months for patients who received an inactive substance (placebo). All patients in the study received standard medical care.

Reported adverse events included damage to blood cells, fatigue, nausea, loss of appetite, tingling or numbness in the hands and feet, and skin rash.

Alimta initially was approved in 2004 for the treatment of patients with mesothelioma, a cancer frequently related to asbestos exposure. It was later approved for the treatment of patients with non-small cell lung cancer whose disease worsened on prior chemotherapy drugs and also as an initial therapy for advanced non-small cell lung cancer.

Alimta is manufactured by Eli Lilly & Co. of Indianapolis.

 



FDA Approves Lung Cancer Drug...

What Women -- and Men -- Should Know about Breast Cancer

The Healthy Geezer

Breast cancer is second behind lung cancer as the leading cause of cancer death in women. The chance of developing invasive breast cancer at some time in a woman's life is about 1 in 8.

The female breast is composed primarily of milk-producing glands (lobules), ducts that connect the glands to the nipple, and soft tissue.

Breast cancer is a malignant tumor that has grown from breast cells. Nearly all breast cancers start in the ducts or lobules of the breast. The cancer can spread (metastasize) to other parts of the body, but it will continue to be defined as breast cancer.

Types of breast cancer

There are many forms of breast cancer.

Infiltrating ductal carcinoma (IDC) is the most common form. It starts in a duct, then breaks through the duct wall and invades the tissue of the breast. At this point, it can metastasize through the lymphatic vessels and the bloodstream. About 80% of invasive breast cancers are infiltrating ductal carcinomas.

Lymph plays a major role in breast cancer. It is a fluid that carries immune-system cells through lymphatic vessels. Lymph nodes are small collections of these cells in the vessels. Almost all lymphatic vessels in the breast connect to lymph nodes under the arm. Cancer cells that enter lymphatic vessels can spread and begin to grow in lymph nodes. This is why doctors check the lymph nodes to see if breast cancer has spread.

Ductal carcinoma in situ (DCIS) is the most common type of noninvasive breast cancer.

The term in situ means the cancer is confined to its original site. DCIS denotes that the cancer cells are inside the ducts but have not spread through the walls of the ducts into the surrounding breast tissue. About 20% of new breast cancer cases will be DCIS. Nearly all women diagnosed at this early stage of breast cancer can be cured.

Risk factors

There are many risk factors for breast cancer.

• The risk rises with age. About 77% of women with breast cancer are older than 50 when they are diagnosed.

• Breast cancer risk is higher among women whose close relatives have the disease.

• A woman with cancer in one breast is at high risk of developing a new cancer in either of her breasts.

• Women who started menstruating before age 12 or who went through menopause after age 55 have a slightly higher risk of breast cancer.

• Having multiple pregnancies and becoming pregnant at an early age reduces breast cancer risk.

• Long-term use of hormone replacement therapy (HRT) after menopause increases your risk of breast cancer.

• Drinking alcohol is linked to an increased risk of developing breast cancer.

• Obesity is a breast cancer risk, especially for women after menopause.

Evidence is growing that exercise reduces breast cancer risk.

Diagnosis

The most common breast cancer symptom is a lump. Other symptoms include swelling, skin irritation, nipple pain or retraction, and an unusual discharge.

Early diagnosis saves lives. The combination of a mammogram, a clinical breast exam and self-exams is recommended by healthcare experts to reduce breast-cancer deaths.

A mammogram is a breast x-ray. If mammography finds an abnormality, confirmation by biopsy is required. In a biopsy, a tissue sample is taken for analysis.

About 2/10 percent of mammograms lead to a cancer diagnosis. About 10 percent of women examined will need another mammogram. Only about 10 percent of those women will need a biopsy. Out of those biopsies, 80 percent will come back negative for cancer.

Women 40 and older should have an annual mammogram and breast exam by a healthcare professional. As long as a woman is in good health and would be a candidate for treatment, she should continue to get mammograms and exams.

Research has shown that self exams help find breast cancer. Self examination teaches women how their breasts feel normally and to notice changes.

Ultrasound and MRI are other diagnostic tools.

Ultrasound uses high-frequency sound waves to outline a part of the body. Breast ultrasound can focus upon something picked up by a mammogram.

Magnetic resonance imaging (MRI) use radio waves and strong magnets instead of x-rays. They can be used to examine cancers found by mammogram.

Treatment

Most women with breast cancer have some type of surgery. Surgeries include lumpectomy to remove only the breast lump and surrounding tissue, a mastectomy that removes part or all of the breast or can be more extensive to include lymph nodes and muscle tissue.

Radiation therapy is another form of treatment. It uses high-energy rays or particles that destroy cancer cells. This treatment may be used to destroy cancer cells that remain in the breast, chest wall, or underarm area after surgery.

Medicines are also used to treat breast cancer. Chemotherapy employs intravenous and oral drugs that can kill cancer cells in most parts of the body. The anti-estrogen drug tamoxifen has been used for more than 20 years to treat breast cancer.

Hormone replacement therapy (HRT) to treat menopause symptoms and its relationship to breast cancer has become a controversial issue. Unfortunately, many women experience menopausal symptoms after treatment for breast cancer.

In the past, doctors had offered HRT after breast-cancer treatment to women suffering from severe symptoms. However, recently, a study found that breast cancer survivors taking HRT were much more likely to develop a new or recurrent breast cancer than women who were not taking the drugs. This study discouraged doctors from recommending HRT to breast-cancer patients.

Phytoestrogens, estrogen-like substances, may be safer than the estrogens used in HRT. However, there is insufficient data on phytoestrogens to evaluate their safety for breast cancer survivors.

Male breast cancer

Breast cancer strikes most often when men are in their sixties.

Male breast cancer? Men do have breast cells that can become cancerous. The disease is uncommon in men. It represents only 1% of all breast cancers. Because of its rarity, many men arent aware it exists. And thats a problem.

For unknown reasons, the incidence of male breast cancer has been increasing. About 2,000 men in the U.S. are diagnosed with breast cancer annually.

Young boys and girls have a small amount of breast tissue made up of a few ducts. At puberty, female hormones in girls make breast ducts grow, milk glands form and fat increase. The male hormones in boys prevent further growth of breast tissue. Men's breast tissue contains ducts, but only a few if any lobules.

The most common symptom of male breast cancer is the same as it is for women a lump. Other signs include: skin dimpling, a new indentation of the nipple, redness or scaling of breast skin, a clear or bloody discharge from the nipple.

Risk factors

Some risk factors for male breast cancer are:

• Age. The average age for a man diagnosed with breast cancer is 67.

• Family. About 20 percent of men with breast cancer are related to someone with the disease.

• Genes. About 7 percent of breast cancers in men are inherited.

• Radiation. Theres a higher risk to men who underwent chest radiation treatments when they were younger.

• Klinefelter Syndrome. Men with this syndrome make lower levels of male hormones androgens and more female hormones. This can cause gynecomastia, benign breast enlargement. Men with this condition may be at greater risk of breast cancer. Many medicines used to treat ulcers, high blood pressure, and heart failure can cause gynecomastia, too.

• Estrogen. The risk is small for men who take estrogen the main female hormone. Estrogen drugs may be used to treat prostate cancer.

• Liver disease. This can increase your risk of gynecomastia and breast cancer.

• Obesity. Fat cells convert androgens into estrogen.

• Alcohol. Drinking alcohol raises the odds that a man will develop breast cancer. The risk increases with the amount of alcohol consumed.

If a man has a family history of the disease, he should consult a doctor about regular testing. Diagnostic tests for men include a clinical breast exam, mammograms, ultrasound, biopsy and, if indicated, a nipple discharge exam.

Breast cancer treatment for men is similar to that given to women. Some men may need only surgery. Others will need surgery and radiation, chemotherapy or hormone therapy.

There isnt much tissue to a man's breast, so removing the cancer usually means excising most of the tissue. The procedures that are used on women to save breast tissue arent practicable for men.

Most men with breast cancer require a modified radical mastectomy. In this procedure, a surgeon removes the entire breast and some underarm lymph nodes, but leaves chest muscles intact.

All Rights Reserved © 2008 by Fred Cicetti

 



What Women -- and Men -- Should Know about Breast Cancer...

Hispanic Women Three Times More Likely to Develop Advanced Breast Cancer

Study Finds Hispanic Women Also Diagnosed at an Earlier Age

A joint study by researchers at the University of Colorado Health Sciences Center (UCD) and Kaiser Permanente Colorado (KPC), finds that Hispanic women are almost three times more likely to be diagnosed with advanced breast cancer than non-Hispanic women.

The study will be published in the May 15 issue of Cancer, the medical journal of the American Cancer Society.

The differences were observed even after the researchers adjusted for factors such as socioeconomic status, the length of time that the women had been enrolled in the managed health care system, and regular checkups.

The study, conducted between 1995 and 2004, included 139 Hispanic women and 2,118 non-Hispanic breast cancer patients. They were all interviewed in Colorado, where they lived.

The researchers observed that the Hispanic patients were diagnosed with more advanced and more aggressive breast cancer. Hispanics were nearly three times more likely to be diagnosed with stage IV disease and twice as likely to have larger tumors, characteristics that result in poorer prognosis. In addition, more Hispanic patients had tumors that lack receptors for the hormone estrogen (ER-negative) which makes the disease more difficult to treat.

Moreover, the Hispanic patients were diagnosed at an earlier age, with an average age of 56 at the time of first diagnosis, compared to 61 for non-Hispanic patients.

The study compared demographic characteristics of the patients to determine if having health insurance affects differences in the presentation of the disease.

The authors of the study concluded that "the persistent findingsof advanced state, larger tumor size ... and fewer cases with estrogen receptors may suggest that true biological differences exist in breast cancer by ethnicity."

Previous research has shown that the incidence of breast cancer varies according to race and ethnicity.

About 203,500 women will be diagnosed with breast cancer in the United States this year. Surgery and chemotherapy are standard treatment options for most forms of breast cancer. Early detection is vital to increase the chances of survival, thus the American Cancer Society recommends that women 40 and older get a mammogram every year.



Hispanic Women Three Times More Likely to Develop Advanced Breast Cancer...

FDA's Breast Implant Decision Shows 'Double Standard,' Critics Charge

"Most defective medical device ever ..." says Public Citizen

Critics are assailing the U.S. Food and Drug Administration's decision to allow the marketing of silicone gel-filled breast implants made by two companies. Public Citizen labeled them the "most defective medical device ever approved by the FDA."

"It is a terrible reminder of the double standard for women versus men that the FDA has not approved silicone gel testicular implants because of the inadequacy of clinical trials on these devices," said Dr. Sidney Wolfe, Director of Public Citizen's Health Research Group.

The FDA approved implants manufactured by manufactured by Allergan Corp. (formerly Inamed Corp.), Irvine, Calif., and Mentor Corp., Santa Barbara, Calif., for breast reconstruction in women of all ages and breast augmentation in women ages 22 and older.

"FDA has reviewed an extensive amount of data from clinical trials of women studied for up to four years, as well as a wealth of other information to determine the benefits and risks of these products," said Daniel Schultz, M.D., Director, Center for Devices and Radiological Health, FDA.

"The extensive body of scientific evidence provides reasonable assurance of the benefits and risks of these devices. This information is available in the product labeling and will enable women and their physicians to make informed decisions."

The FDA will continue to monitor the devices by requiring each company to conduct a large postapproval study following about 40,000 women for 10 years after receiving breast implants.

Public Citizen has opposed the use of silicone gel breast implants since the fall of 1988, when it petitioned the Food and Drug Administration (FDA) to ban them after receiving what it said numerous documents from FDA scientists concerned about their safety.

"In terms of adverse safety and health information known at the time of approval -- such as high rates of rupture, the need for repeat surgery and clear evidence of lymph node infiltration and damage by leaked silicone -- silicone gel breast implants are the most defective medical device ever approved by the FDA," Wolfe said.

"The approval makes a mockery of the legal standard that requires 'reasonable assurance of safety,'" he said.

FDA said its decision was based on a thorough review of each company's clinical and preclinical studies, a review of studies by independent scientific bodies and deliberations of advisory panels of outside experts that heard public comment from hundreds of stakeholders.

In addition, FDA conducted inspections of each company's manufacturing facilities to determine that they comply with FDA's Good Manufacturing Practices. Some of the complications reported in the core studies included hardening of the area around the implant, breast pain, change in nipple sensation, implant rupture and the need for additional surgery.

However, FDA said the majority of women in the studies reported being satisfied with their implants.

FDA approved the silicone gel-filled breast implants with a number of conditions, including requiring each company to: conduct a large postapproval study; continue its core study through 10 years; conduct a focus group study of the patient labeling; continue laboratory studies to further characterize types of device failure; and track each implant in the event, for example, that health professionals and patients need to be notified of updated product information.

The postapproval studies will continue to gather information about the safety and effectiveness of the implants. Information will be collected about rates of local complications, rates of connective tissue disease and its signs and symptoms, rates of neurological disease and its signs and symptoms, potential effects on offspring of women with breast implants, potential effects on reproduction and lactation, rates of cancer, rates of suicide, potential interference of breast implants with mammography, and MRI compliance and rupture rates.

Wolfe said Public Citizen will also remain interested. "We will certainly be urging thorough Congressional investigations and hearings on this lack of assertion of regulatory authority by (FDA)," he said.



FDA's Breast Implant Decision Shows 'Double Standard,' Critics Charge...

Breast Implant Complications Frequent, Study Finds

Almost one-third of women who underwent reconstructive breast implantation after mastectomy had at least one short-term complication

Almost one-third of women who underwent reconstructive breast implantation after mastectomy had at least one short-term complication in the chest or breast area, with one in five women requiring additional surgery, according to a study in the December issue of Archives of Surgery.

The most common complications were infection, blood clotting, seroma (collection of serum in the tissues) and skin perforation. Forty-nine percent of these complications occurred within three months and 67 percent within six months.

"Surgical or medical intervention is commonly required during the reconstructive course, but reconstruction failure (loss of implant) is rare," the authors report.

Women with breast cancer and their physicians often face several choices in the course of treatment, including whether to remove the breast (mastectomy) or undergo breast-conserving therapies, when and whether to reconstruct the breast following mastectomy and what materials to use in doing so.

Surgeons performing postmastectomy reconstruction can form the new breast from flaps of skin and other tissue from the womans body (autologous tissue) or insert an implant, and sometimes use both techniques at once.

Many women choose implants alone because the procedure is simpler and requires less operation time than those using autologous tissue, and it can preserve the color of the skin of the breast and possibly some of its sensitivity.

Trine F. Henrikson, M.D., of the Danish Registry for Plastic Surgery of the Breast (DPB), Copenhagen, Denmark, and colleagues analyzed data from 574 women in the registry who underwent postmastectomy breast reconstruction between June 1, 1999, and July 24, 2003.

The patients surgeons reported the dates and details of each implantation and filled out follow-up forms when the women returned for subsequent visits. The women, ages 21 to 78 years with a mean (average) age of 51 years, were monitored through Sept. 15, 2003.

Following their first implantation, 31 percent of the women developed at least one adverse event, 16 percent developed two complications and 8 percent experienced three or more during the course of the study.

Additional surgery was required for 21 percent of the women, while 3 percent underwent additional nonsurgical treatment. Surgery was most often needed to correct asymmetry of the breasts, displacement of the implant or capsular contracture, when the capsule-like scar tissue that forms around the implant tightened and hardened.

The researchers also examined data on the 302 women in the study who had reimplantations, usually to exchange or replace the existing implant.

These women had similar rates of complications -- 36 percent of them developed at least one adverse event and 21 percent required additional surgery.

"When evaluating benefits and risks associated with breast reconstruction, the surgeon and patient should consider that the reconstructive process often requires additional surgical interventions to treat local complications or to achieve the desired cosmetic result," the authors conclude.

"Detailed information on the likelihood of local complications associated with the given indication (cosmetic vs. reconstructive) should be an essential part of adequate informed consent for women seeking breast implantation."

 

Breast Implant Complications Frequent, Study Finds...

That Pink Ribbon Can Be Misleading, Consumer Group Warns

Not all companies and groups promoting breast cancer awareness are created equal

It takes more than a pink ribbon logo to provide meaningful support to breast cancer research, a consumer group warns.

Breast Cancer Action, a San Francisco-based grassroots education and advocacy organization, says not all companies and groups promoting breast cancer awareness are created equal. The group is encouraging consumers to be more savvy about how they give to breast cancer.

BCA said it is concerned that many companies selling pink ribbon products mislead consumers due to their lack of transparency and accountability.

"When companies put pink ribbons on their products, they're no longer just selling a sweater or a watch -- they're selling the expectation that buying their product is going to make a difference in the fight against breast cancer," said Barbara Brenner, executive director of Breast Cancer Action.

"Pink ribbon marketing efforts make a significant difference in corporate bottom lines. But the 'portion of the proceeds' that goes to breast cancer is all too often miniscule in comparison."

The group cited 3M as an example of a company that uses breast cancer awareness in its marketing campaign, but gives a relatively small amount to the cause.

"Breast cancer is a serious disease. Every 1.9 minutes a woman hears the words, 'You have breast cancer,' and every 13 minutes a woman dies from the disease," Brenner said.

"People care deeply about this disease and want assurance that pink ribbon products are as beneficial to women with breast cancer as they are to the companies that sell them."

Think Before You Pink features a one-minute Flash movie on the BCA Web site, focused on pink ribbon cause-marketing. The Flash movie culminates with an opportunity to send an e-mail to companies selling pink ribbon products, asking how much money actually goes to the cause, how the funds are being raised, who gets the money, and what types of programs are being supported.

Also online, BCA's "Parade of Pink" lists more than 50 examples of the hundreds of pink ribbon products marketed by companies including Cartier, Ford, Kodak, Quilted Northern, Ralph Lauren, Tommy Hilfiger, Yoplait and more.

 

That Pink Ribbon Can Be Misleading, Consumer Group Warns...

Study Ties Fries To Breast Cancer Risk

The study involved more than 2,000 female registered nurses

Girls who eat lots of French fries during their pre-school years grow up to have a higher risk of developing breast cancer, according to researchers at Brigham and Women's Hospital. Their study, published in the International Journal of Cancer, categorizes the increased risk as "significant."

The study involved more than 2,000 female registered nurses, and found that those who regularly consumed French fries when they were young had a higher incidence of breast cancer than those who did not.

The authors said the study provides additional credence to the belief that early eating habits impact a womans health later in life.

The study examined the diets of the women when they were between the ages of three and five. Mothers of the subjects were questioned about the frequency of consumption of about 30 specific food items.

Upon reviewing the data, researchers say they found that for each additional serving of French fries per week when they were preschoolers women had a 27 percent increased risk of breast cancer later in life.

Whats the connection? Researchers say more study is needed, but that its unlikely potatoes are the culprit. Instead, they suggest that frying the potatoes in fat and trans-fatty acids might play a role.

 

Study Ties Fries To Breast Cancer Risk...

FDA Opens Breast Implant Review

Silicone breast implant safety being debated once again

The Food and Drug Administration's advisory panel on General and Plastic Surgery Devices meets this week to review data on the safety of silicone breast implants. The panel will vote Tuesday on Inamed Corporation's application for approval, and on Wednesday on Mentor Corporation's application.

"This is the third time both companies have applied for FDA approval" said Dr. Diana Zuckerman, president of the National Research Center for Women & Families. "The first unsuccessful effort was in 1991, so the companies have had more than enough time to study these products? Why have they provided no long-term safety data?"

Both companies applied for FDA approval again in 2002-3, but Mentor withdrew its application when Inamed's implants were not approved in January 2004.

When the FDA refused to lift restrictions on the sale of silicone gel-filled breast implants at that time, the FDA explained their decision was based on concerns about rupture, unknown complication rates, and the long-term safety of silicone in the body.

Last week, the FDA publicly released its scientific review of the companies' applications. The group says the reviews indicate that FDA scientists found that the industry data are insufficient to answer many of their concerns. In addition, it points to data it says reveal significant problems with the devices.

Rupture

The FDA's probability analysis, provides several estimates based on industry data. Assuming that implants, like other products, are more likely to break as they get older, the most realistic estimate indicates that three-quarters of implanted women will have at least one ruptured implant within a decade of receiving the devices.

Specifically, these data estimate that 93% of breast cancer reconstruction patients should expect at least one broken implant, 38% of augmentation patients, and 66% of women who replace previous breast implants with new ones.

Leakage

Approximately one in four women have silicone leaking outside their scar tissue capsules, and silicone seepage increases over time.

When that happens, women are more likely to report breast hardness, fatigue and other auto-immune symptoms, and, perhaps, auto-immune diseases.

Other problems include painful hardening of the breast, changes in nipple sensation, dying breast tissue, and other complaints.

Long-Term Safety

While the data submitted by the manufacturers did not provide evidence of long-term safety, other researchers have conducted studies that indicate increased risks:

National Cancer Institute researchers found that women with implants were twice as likely to die of brain cancer, three times as likely to die of lung cancer, and four times as likely to commit suicide, compared to other plastic surgery patients.

FDA scientists studied women who had silicone breast implants for at least six years, and found that women with extracapsular silicone leakage were significantly more likely to report a diagnosis of painful and debilitating diseases such as fibromyalgia.

A Canadian study found that women with breast augmentation were more likely to be hospitalized compared to other women of the same age in the same communities, and augmentation patients also had more medical visits.

Mammography

Breast implants interfere with the detection of breast cancer. A study published in the January 2004 of the Journal of the American Medical Association (JAMA) found that mammograms missed 55% of breast cancers in women with breast implants, compared to 33% in women without implants.

After hearing the manufacturer's data at the 2003 October panel meeting, advisory panel chairman Dr. Thomas Whalen wrote a letter to the FDA dated October 31 where he noted that mammography was a key concern, writing that "[t]here is at least one facet of long-term danger that was established during the panel -- specifically the obscuration of surrounding normal breast tissue to mammographic detection of breast cancer."

Toxic Chemicals

An article published in the Annals of Bioanalytic Chemistry reported alarmingly high levels of a dangerous form of platinum in children born to women with breast implants. Platinum is a known toxic chemical.

 



FDA Opens Breast Implant Review...