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Hot flushes, night sweats or painful joints may be good news for women taking hormone-based drugs for breast cancer — it may mean their tumors are less likely to return, researchers said on Thursday.

Women with any of these menopause-like symptoms after taking AstraZeneca’s breast cancer drug Arimidex or generic tamoxifen were 30 percent less likely to have their cancer return over the next nine years, they found.

“The treatment is designed to starve potential cancers of estrogen and these symptoms mean that there are lower levels of estrogen in the body,” said Jack Cuzick, an epidemiologist at Cancer Research UK, who led the study published in the journal Lancet Oncology.

“But it is too early to say whether having these symptoms is essential for the treatment to be effective. At the moment all we can say is that the symptoms indicate the likely success of the treatment.”

Breast cancer is the leading cause of cancer deaths among women worldwide, according to the American Cancer Society. The group estimates about 465,000 women died of breast cancer globally in 2007, and 1.3 million new cases were diagnosed.

Declining death rates from breast cancer in developed countries have been attributed to early detection through mammography screening and to improved treatment.

The researchers looked at some 4,000 post-menopausal women treated with either Arimidex, known generically as anastrozole, or the older cancer drug tamoxifen. Arimidex is one of a newer class of drugs called aromatase inhibitors that cannot be taken by women not yet through menopause.

Women who reported hot flushes, night sweats or painful joints within three months of treatment were more likely to remain free of their cancer and these early side effects may also help doctors more effectively target future treatment.

“Our main message is: No pain, no gain,” Ivana Sestak, a Cancer Research UK researcher who worked on the study, said in a telephone interview.

Sestak added the researchers do not know why some women responded differently but believe genetics is the likely explanation because every person metabolizes the drugs that cause a drop in estrogen differently .

By Reuters

Obesity can wreck a person’s health for many reasons. But for women, too much weight tacks on an additional danger: Studies have linked obesity and breast cancer in a variety of ways.

Doctors aren’t sure why this link exists and are trying to figure out what ties weight gain to breast cancer. But they are more and more convinced the link is there, and they are urging women to watch their weight and increase their exercise to help stave off what is the most common cancer among females, nonmelanoma skin cancer aside.

“There are a lot of factors we need to figure out,” said Dr. Jennifer A. Ligibel, of the Dana-Farber Cancer Institute in Boston. “There are a lot of things we don’t know.”

An estimated 182,500 women in the United States will be found to have invasive breast cancer in 2008, according to the American Cancer Society, and about 40,480 women will die from the disease this year. Currently, there are about 2.5 million breast cancer survivors in the United States.

Studies have found that, in general, obesity is linked to cancer. The higher a person’s body-mass index (BMI, a ratio of weight to height), the more likely she or he will develop cancer, according to recent research by scientists at the University of Manchester in England. Other studies have found similar links to increased body fat.

Still other studies have found that women with breast cancer are more likely to live shorter lives and suffer a recurrence of their cancer if they are overweight.

For example, in a recent study conducted at the University of Texas M.D. Anderson Cancer Center in Houston, more than two-thirds of women with stage III locally advanced breast cancer were either overweight or obese. The study also found that a greater proportion of obese patients were likely to be diagnosed with a rare and more deadly form of breast cancer, known as inflammatory breast cancer.

Scientists vary in their opinions on why this link exists, and what it means.

Some believe that obesity may make tumors harder to detect, so a woman’s breast cancer will be further developed before it is discovered.

“It could be because there’s more breast tissue, a lump would be less evident,” Ligibel said.

Researchers also believe that the systemic effects of obesity might do something to spur cancer on. For example, obesity or overweight can lead to fluctuations in hormone levels in the body.

“When women are heavier, their estrogen levels are higher,” Ligibel said. “That could be a pathway through which weight affects breast cancer. Other studies have shown that when insulin levels are high, there’s more chance a cancer will come back.”

Another link to obesity was found in a study from the University of North Carolina at Chapel Hill that showed that obese women are more likely to skip screenings for breast and cervical cancer. Without those screenings, women are less likely to catch breast cancer at a more treatable stage.

Debbie Saslow, director of breast and gynecologic cancer at the American Cancer Society, said it’s not completely clear what role obesity plays in breast cancer risk.

“For obesity, which is independent of breast size, I would think two factors would come into play,” Saslow said. “One, a positive, is that the breasts may be fattier, which would make a mammogram easier to read. The second, a negative, is indirect: Obese women are less likely to go to a doctor.”

Menopause appears to be a critical time, Ligibel said. Obesity creates a greater risk for breast cancer post-menopause, while pre-menopausal women actually have a reduced risk.

“Gaining weight around the time of menopause is a risk factor in developing breast cancer,” Ligibel said.

The increased risk of developing breast cancer and dying of it after menopause is believed due to increased levels of estrogen in obese women, said Colleen Doyle, director of nutrition and physical activity with the American Cancer Society.

There is good news. Studies have shown that exercise — 30 minutes to 60 minutes a day of moderate-to-high intensity physical activity — decreases breast cancer risk, Doyle said.

“Physical activity reduces breast cancer risk both directly, by decreasing circulating estrogens, and also indirectly, by helping with weight control,” she said. “Women are so concerned about breast cancer risk. Communicating that there are key things you can do to reduce risk — watch your weight and be more active — are valuable messages.”

Ligibel agreed, noting that exercise might be valuable enough to counteract the strain on the body caused by obesity.

“You might not need to lose weight if you exercise,” Ligibel said. “Exercise could affect the hormone levels and help keep cancer from occurring or recurring.”

By HealthDay

Breast cancer survivors who suffer from hot flashes can reduce these attacks significantly with hypnosis, a new study finds.

Hot flashes are a problem for many women who survive breast cancer. Not only do they cause discomfort, but they interrupt sleep, cause anxiety and affect a woman’s quality of life.

“This is a very encouraging study of hypnosis as a treatment for hot flashes in breast cancer survivors,” said Dr. Ted Gansler, director of Medical Content at the American Cancer Society, who was not involved in the study. “This is an important topic because of the high prevalence of these symptoms in breast cancer survivors, and because few other treatment options are both safe and effective for this population,” he added.

There have been some other studies of hypnosis and cancer that indicate that the treatment is useful, but currently underutilized, Gansler noted.

The report was published in the September issue of the Journal of Clinical Oncology.

For the study, researchers led by Gary Elkins, a professor of psychology at Baylor University, randomly assigned 60 breast cancer survivors who suffered from hot flashes to five weekly sessions of either hypnosis or no treatment.

During each session of hypnosis, women were given mental imagery and suggestions for relaxation and coolness. They were also told to disassociate themselves from hot flashes. In addition, they were taught to use positive suggestions and imagery during self-hypnosis.

Women who underwent hypnosis had an average 68 percent decrease in the frequency and severity of hot flashes, the researchers found. In addition, these women said they experienced less anxiety and depression. They also had significant improvements in sleep and their ability to perform daily activities, compared with women who received no treatment.

“Women are interested in alternatives to traditional hormone therapy and pharmacologic interventions, and this study demonstrates the feasibility and potential effectiveness of hypnosis as an alternative treatment,” the researchers concluded.

But since the control group received no treatment, it’s difficult to say whether some or even all of the improvement represents a “placebo effect,” Gansler noted. “However, the researchers reasonably suggest that the improvement is so substantial that it is unlikely to be due entirely to a placebo effect,” he said.

Nancy E. Avis, a professor in the department of social sciences and health policy at Wake Forest University School of Medicine, and author of an accompanying journal editorial, agreed that hot flashes are a symptom of cancer treatment that needs to be paid attention to.

“We don’t have good interventions for hot flashes,” Avis said. “We know that hormone therapy treats hot flashes, but women who have had breast cancer don’t want to take hormone therapy,” she said.

Many mind-body approaches are promising, Avis said. “The hypnosis study has impressive results, but we need more research,” she said. “Based on these small studies, we are not ready to say they work.”

Avis believes alternative approaches such as hypnosis are appealing to a lot of women. Many other approaches such as meditation and yoga are available at cancer centers, she noted.

“There is no reason to think they are not safe,” Avis said. “The advice is — try it — there is no harm in trying. As long as you do it with somebody who knows what they’re doing, there are no downsides,” she said.
By Steven Reinberg (HealthDay News)

Women who were bigger and longer babies may be more likely to develop breast cancer, researchers reported on Tuesday.

The study adds to evidence that, at least in some cases, something that happens in the womb may cause cancer later in life.

Previous research into links between birth size and breast cancer have proved inconsistent, but the findings published in the Public Library of Science journal PLoS Medicine are strong evidence that the two may be related.

“These findings provide strong evidence that birth size — in particular birth length — is a marker of a woman’s breast cancer risk in adulthood, although the mechanisms underlying this association are unclear,” Isabel dos Santos Silva of the London School of Hygiene and Tropical Medicine and colleagues wrote.

Breast cancer is the leading cause of cancer deaths among women worldwide, according to the American Cancer Society. The group estimates about 465,000 women died of breast cancer globally in 2007, and 1.3 million new cases were diagnosed.

Declining death rates from breast cancer in developed countries have been attributed to early detection through mammography screening and to improved treatment.

Dos Santos Silva and colleagues examined 32 studies comprising 600,000 women, mainly in developed countries. Their analysis included more than 22,000 women who had breast cancer.

After considering established risk factors such as age and late menopause, the researchers found a strong association with birth size, birth length and head circumference. Of the three, birth length showed the strongest link.

“The amount by which birth size affected breast cancer risk was not affected by allowing for other established risk factors,” the researchers wrote.

For example, women with recorded birth weights of 4 kilograms or more had a 12 percent higher chance of breast cancer than babies weighing 3 to 3.5 kilograms at birth, the study found.

The link between breast cancer and birth size appeared smaller when compared with other risk factors. The researchers estimated that birth size may be responsible for up to 5 percent of all women who develop breast cancer by the age of 80.

Some research has linked hormones such as estrogen and human growth hormone with cancer.

The researchers noted age of puberty and adult height are also associated with breast cancer risk, and growth as a fetus can predict a girl’s growth, so there could be a link there.

“The maternal and/or foetal hormonal environment associated with large birth size may alter programing of the breast, making it more susceptible to cancer,” the researchers wrote.

by Michael Kahn | Maggie Fox and Tim Pearce ( LONDON Reuters )

WASHINGTON — Remember peeking through a View-Master? Scientists are using the same concept behind the classic kids’ toy to try to see mammograms in 3-D.

The goal: A better way to check for breast cancer in women with breasts too dense for today’s mammograms to give a clear picture.

Radiologists donning 3-D glasses isn’t the only potential aid. The Mayo Clinic in Rochester, Minn., is testing a new kind of breast camera that might challenge the images of those far pricer MRI exams now reserved for the most high-risk women, but at a fraction of the price.

Both technologies still are experimental. But the research is being watched closely because the need is so great: Half of women younger than 50 and a third of women over 50 are estimated to have dense breasts.

In addition to a harder time viewing any brewing tumors, women with dense breasts have a higher risk of getting breast cancer, too.

Only a mammogram can tell if your breasts are made up more of dense or easier-to-examine fatty tissue. But if a doctor warns that you have dense breasts, there’s little good advice on how to get a better cancer check today.

“It’s a major issue in the field now, more and more, how to address the imaging needs of women with significant breast density,” says American Cancer Society screening specialist Robert Smith. “We and women and everyone else is kind of left wondering what would be best under what circumstances.”

But, “we can do better than we’re doing,” predicts Dr. Mary S. Newell, assistant breast-imaging chief at Emory University in Atlanta, who is testing the 3-D approach.

Read the rest of this entry »

Two tiny genetic variations may provide the best clues yet for finding more precise ways to estimate prostate cancer risk and improve screening and early detection for men of African descent, report researchers from the University of Chicago and the Translational Genomics Research Institute, Phoenix, AZ, in the December 2007 issue of Genome Research, published early online.

The researchers set out to determine whether results from four previous studies that linked genetic variations on one region of chromosome 8 to increased prostate cancer risk among Caucasians were also valid for men of African heritage. In the process, however, they found an additional genetic variation among African American men that was an even stronger marker for cancer risk for these men. That variation is located within a gene that plays a role in DNA repair. A malfunction in DNA repair could contribute to cancer development.

“This finding emphasizes the importance of ancestry in studying genetics,” said study author Rick Kittles, associate professor of medicine at the University of Chicago Medical Center. “Previous studies led us to one specific region of chromosome 8,” he said. “Then this approach—which took advantage of genetic differences among African American men, who are at very high risk for this type of cancer—led us to a different locus within that region and directly to a gene of interest.”

Prostate cancer is the most common male malignancy and the second leading cause of cancer death in men. According to the American Cancer Society, it will affect nearly 220,000 men in the United States in 2007 and claim the lives of more than 27,000. It disproportionately affects African Americans who “exhibit the highest rate worldwide,” Kittles said.

In this study, research groups lead by Kittles and by John Carpten of the Translational Genomics Research Institute analyzed the region of chromosome 8 highlighted by the earlier studies done on Caucasian men. But this time they searched for tiny genetic differences between 490 African American men who had been diagnosed with prostate cancer at Howard University Hospital in Washington, DC, and 567 African American men without cancer.

The researchers were able to replicate the linkage between one of the markers detected by previous studies and increased risk. More important, they found a new genetic marker, known as rs7008482, that was even more strongly associated with prostate cancer in African Americans. This marker was located within a gene that is involved in DNA replication, recombination and repair.

Altering this gene could confer an “inherited predisposition to genetic instability,” Kittles said. “This could lead to increased cancer risk. By studying this region, we may be able to develop molecular targets for improved screening, early detection, and possibly treatment.”

Multiple studies, the authors conclude, strongly support the existence of several independent genetic variants that could increase prostate cancer risk within this small region of chromosome 8. They have already begun to look closer at this region and to study the function of nearby genes.

The study also reinforces the need to keep ancestry in mind when looking at disease-gene genetics. “Since African Americans vary significantly in genetic ancestral proportions and the prevalence of prostate cancer is almost two-fold higher among African Americans compared to European Americans,” Kittles said, “the use of ancestry-informative markers for association with prostate cancer is quite powerful.”

The National Institutes of Health and the Department of Defense supported this research. Additional authors include Jada Benn Torres, Stanley Hooker, and Wenndy Hernandez of the University of Chicago; Christiane Robbins and Angel Candreva from the Translational Genomics Research Institute; Carolina Bonilla of the University of Oxford (UK), and Chiledum Ahaghotu of Howard University Hospital.

Source: University of Chicago Medical Center

The next cancer-fighting therapeutic could be growing in your garden, according to research presented at the American Association for Cancer Research’s Sixth Annual International Conference on Frontiers in Cancer Prevention Research.

For example, a black raspberry-based gel might offer a means of stopping oral lesions from turning into a particularly dangerous and disfiguring form of cancer. And new studies show that cancer prevention might come in drinkable form: green tea extract, a powerful antioxidant, shows efficacy against colorectal cancer; and a new berry-rich beverage, made from a combination of known plant-based antioxidants, could prevent or slow the growth of prostate cancer.

Some of the promising studies include:

Chemopreventative effects of a topically applied black raspberry gel on oral premalignant tumors.

Oral squamous cell carcinoma is a deadly cancer that, even when treated successfully, often leaves patients permanently disfigured. Other than radical surgery, there are few known treatments. Researchers at Ohio State University, however, report a Phase I/II trial demonstrating that a gel made from black raspberries shows promise in preventing or slowing the malignant transformation of precancerous oral lesions.

“Black raspberries are full of anthocyanins, potent antioxidants that give the berries their rich, dark color, and our findings show these compounds have a role in silencing cancerous cells,” said Susan Mallery, D.D.S., Ph.D., professor in the Department of Oral Maxillofacial Surgery and Pathology at Ohio State University’s College of Dentistry. “This gel appears to be a valid means of delivering anthocyanins and other cancer-preventing compounds directly to precancerous cells, since it slowed or reduced lesion progression in about two-thirds of study participants.”

According to American Cancer Society statistics, oral cancer is one of the deadliest of all cancers, with about 35,000 new cases each year in the United States and 7,500 deaths annually. These cancers generally begin as small, often unnoticed, lesions inside the mouth. “More than a third of untreated precancerous oral lesions will undergo malignant transformation into squamous cell cancer, but we do not have the capability to predict which lesions will progress,” Mallery said.

The National Cancer Institute-funded trial included 30 participants, 20 of whom had identifiable precancerous lesions, and 10 normal controls. Each of the participants was instructed to gently dry the lesion sites (or a pre-selected control site for the normal participants) and rub the gel into the area four times a day, once after each meal and at bedtime.

After six weeks, about 35 percent of the trial participants’ lesions showed an improvement in their microscopic diagnosis, while another 45 percent showed that their lesions had stabilized. About 20 percent showed an increase in their lesional microscopic diagnoses. Importantly, none of the participants experienced any side effects from the gel.

"The trial was designed to test the safety of the gel and detect any possible toxicity, but the next obvious step is a multicenter, double-blind, placebo-controlled Phase II study," Mallery said. "Such a study would enable us to determine that the black raspberries are the active factor and not just the gel base or the act of drying and rubbing the lesions."

The researchers also collected cell samples from the lesion sites of each participant before and after treatment in order to study the genetics and biology of the lesions. The majority of patients with precancerous lesions at the start of the trial showed elevated levels of COX-2 and iNOS, two proteins closely correlated with inflammation and malignant progression. Following treatment, Mallery says, levels of those proteins in the treated lesional epithelial cells decreased dramatically.

Mallery and her colleagues also examined samples for three tumor suppressor genes in order to determine what researchers call "loss of heterozygosity," whether or not a cancer cell has lost one of its two copies of the gene. Such loss greatly increases a cell’s chances of losing the benefit of the tumor suppressor genes due to a second mutation or gene silencing event. Following the trial, the researchers noted that many lesions returned to normal, retaining both copies of each tumor suppressor gene. "We speculate that the chemopreventive compounds in black raspberries assist in modulating cell growth by promoting programmed cell death or terminal differentiation, two mechanisms that help "reeducate" precancerous cells," Mallery said.

"Oral cancer is a debilitating disease and there is a desperate need for early detection and management of precancerous lesions," Mallery said. "While screening can help detect the disease early – and survival rates are definitely improved the earlier the disease is caught – many of these precancerous lesions recur despite complete surgical removal. There are currently no effective chemopreventive treatments which could conceivably serve as either adjunctive or alternative approaches to surgery."

According to Mallery, the development of black raspberries as potential cancer-fighters is the result of decades of research into identification of naturally derived chemopreventive compounds by Ohio State researcher Gary D. Stoner, Ph.D., an emeritus professor at Ohio State University’s College of Medicine and Public Health. Clinical studies stemming from his research are currently underway for oral, esophageal and colorectal cancer.

The gel looks deceptively like black raspberry jam, but it certainly does not taste like something you would want to spread on toast, Mallery says. The bioadhesive gel, which contains 10 percent freeze dried black raspberries, is devoid of many of the tasty sugars found in native berries.

The black raspberry gel was manufactured by the University of Kentucky’s Good Manufacturing Production (GMP) facility. NanoMed Pharmaceuticals is partnering with OSU investigators Mallery, Stoner and Peter E. Larsen D.D.S. and Russell J. Mumper, Ph.D., of the University of North Carolina, in product development.

<h3>Suppressive effects of a phytochemical cocktail on prostate cancer growth in vitro and in vivo. Abstract no. A104:</h3>

A commercially available nutrition drink reduces the growth of tumors in a mouse model of human prostate cancer by 25 percent in two weeks, according to researchers from the University of Sydney. The drink, Blueberry Punch, is a mixture of plant-based chemicals – phytochemicals – known to have anti-cancer properties.

In particular, Blueberry Punch consists of a combination of fruit concentrates (blueberry, red grape, raspberry and elderberry), grape seed and skin extract, citrus skin extracts, green tea extract (EGCG), olive leaf and olive pulp extracts, tarragon, turmeric and ginger.

"We have undertaken efficacy studies on individual components of Blueberry Punch, such as curcumin, resveratrol and EGCG, in the same laboratory setting and found these effective in suppressing cell growth in culture," said Jas Singh, Ph.D., research fellow at the University of Sydney.

"While individual phytochemicals are successful in killing cancer cells, we reasoned that synergistic or additive effects are likely to be achieved when they are combined."

Singh and her colleagues studied the effect of the beverage on both cancer cell cultures and in mouse models that mimic human prostate cancer. After 72 hours of exposure to increasing concentrations of Blueberry Punch, prostate cancer cells showed a dose-dependent reduction in size and viability when compared with untreated cells, Singh says. After feeding mice a 10 percent solution of the punch for two weeks, the tumors in the test mice were 25 percent smaller than those found in mice that drank only tap water.

Because Blueberry Punch is a combination of several ingredients, it could have multiple mechanisms of action, Singh says. "Based on our initial findings, the mechanisms include, at least, the inhibition of the inflammation-related pathways, which is similar to the action of non-steroidal anti-inflammatory drugs; and inhibition of cyclin D1, which is similar to green tea action."

Based on these results, the researchers believe Blueberry Punch is now ready for human prostate cancer trials. Because Blueberry Punch is a food product rather than a drug, it is unlikely to have adverse reactions or side effects assuming that the individual is tolerant to all ingredients, Singh says. "The evidence we have provided suggests that this product could be therapeutic, although it requires clinical validation," Singh said.

The study was partially funded by the makers of Blueberry Punch, Dr. Red Nutraceuticals, a firm located near Brisbane, Australia, but the experiments were designed and conducted independently in the University of Sydney.

<h3>Inhibition of colorectal tumorigenesis in azoxymethane (AOM)-treated rats by green tea polyphenols. Abstract no. A134:</h3>

Elucidating a decade’s worth of conflicting studies of the cancer-fighting benefits of green tea, researchers at Rutgers University have conclusively demonstrated that a standardized green tea polyphenol preparation can prevent the growth of colorectal tumors in a rat model of human colorectal cancer.

Results from previous studies using different tea constituents in this particular rat cancer model, which is thought to closely mimic human cancer, had been inconsistent. The researchers believe their findings will pave the way for clinical trials with green tea polyphenols in humans.

"Our findings show that rats fed a diet containing Polyphenon E, a standardized green tea polyphenol preparation, are less than half as likely to develop colon cancer," said Hang Xiao, Ph.D., research associate at the Department of Chemical Biology in Ernest Mario School of Pharmacy of Rutgers University.

According to Xiao, these results are consistent with previously published results by the project’s primary investigator, C.S. Yang, Ph.D., professor and chair of the Department of Chemical Biology at Rutgers, which showed that green tea consumption was associated with lower colon cancer rates in Shanghai, China.

Xiao and his colleagues treated two groups of mice with azoxymethane (AOM), a widely used agent that has been shown to generate in rats colorectal tumors that share many characteristics with colorectal cancer in humans, Xiao says. They then split the rats into two groups that were each fed a high fat diet, which the researchers believe closely resembles a Western diet; half received a 0.24 percent solution of Polyphenon E. According to Xiao, the green tea extract contains four major polyphenols, the majority of which (about 65 percent) is EGCG, thought to be the main active ingredient.

"When you account for caloric consumption, 0.24 percent Polyphenon E in diet gave the experimental rats the equivalent of about four to six cups of tea a day," Xiao said. "While I can’t make any recommendations for how much green tea people should drink each day, it isn’t uncommon for some to drink that much tea."

After 34 weeks, rats that received Polyphenon E developed 55 percent fewer tumors compared to the control rats that did not receive Polyphenon E. Moreover, the tumors were 45 percent smaller in rats treated with green tea extract. Histopathological analysis by his colleague, Xinpei Hao, Ph.D., also showed that the treatment group had significantly lower incidence and number of malignant colon tumors. The researchers could also detect green tea polyphenols in the blood plasma as well as the colorectal mucosa of the rats who received the extract.

Meanwhile, the test rats weighed about five percent less than their control group counterparts, a result Xiao attributes to the ability of the green tea polyphenols to block lipid absorption in the body, which the researchers had previously demonstrated in a mouse model of obesity.

Source: American Association for Cancer Research (AACR)

The FDA has approved Bayer HealthCare AG’s drug, Nexavar (sorafenib) in patients with hepatocellular carcinoma when the cancer can not be removed surgically. Hepatocellular carcinoma is a type of liver cancer.

Hepatocellular carcinoma accounts for 80-90% of all liver cancers. If it can’t be removed surgically, hepatocellular carcinoma is usually fatal within 3-6 months. The American Cancer Society estimates that there will be more than 19,000 new cases and nearly 17,000 deaths in 2007 from liver cancer and intrahepatic bile duct cancer in the U.S.

Nexavar is a type of anticancer drug called a kinase inhibitor. It interferes with molecules that are thought to be involved in chemical messages sent within cancer cells, in the formation of blood vessels that supply tumors, and in cell death.

FDA’s approval of Nexavar was based on the results of an international randomized placebo-controlled trial in patients with inoperable hepatocellular carcinoma. The study was designed to compare the survival of a group of patients who received the drug against a group of similar patients who did not.

“In a randomized clinical trial, the group of patients with inoperable hepatocellular carcinoma who received Nexavar survived 2.8 months longer than the group of patients who didn’t receive the drug,” said Robert Justice, M.D., director of FDA’s division of drug oncology products. “This is an important new treatment option for patients who are fighting this very difficult form of cancer.”

A total of 602 patients were studied. Each patient received Nexavar or a placebo. Both groups were comparable with regard to age, gender, race, the stage and other characteristics of their cancer, and the types of cancer treatment they had received before entering the clinical trial.

The trial was stopped after a planned interim analysis showed a statistically significant advantage in overall survival for the patients who had received Nexavar. Patients who received Nexavar survived a median of 10.7 months while patients who received placebo survived a median of 7.9 months. A separate analysis showed that tumors progressed more slowly in patients who received Nexavar compared to patients who had received placebo.

The most common adverse reactions that have been observed in patients taking Nexavar (for hepatocellular carcinoma or renal cell carcinoma) are fatigue, weight loss, rash or superficial skin shedding, hand or foot skin reaction, hair loss, diarrhea, anorexia, nausea and abdominal pain. Twenty percent or more of patients had experienced at least one of these reactions. In patients with hepatocellular carcinoma, diarrhea was reported in 55 percent of patients who received Nexavar. Inadequate blood supply to the heart or heart attack were reported in 2.7 percent of patients who received Nexavar, compared to 1.3 percent for patients who received placebo. New high blood pressure was reported in 9 percent of patients who received Nexavar, compared to 4 percent of patients who received placebo.

Elevated serum lipase, an enzyme that measures liver function, occurred in 40 percent of patients who received Nexavar, compared to 37 percent of patients who received placebo, and hypophosphatemia, or low blood levels of phosphate, occurred in 35 percent of patients who received Nexavar, compared to 11 percent of patients who received placebo.

Nexavar comes in 200 milligram tablets and the usual dose is two tablets (400 milligrams) taken twice a day on an empty stomach. Nexavar was originally approved in 2005 for the treatment of patients with advanced renal cell carcinoma, a form of kidney cancer.

Nexavar is manufactured by Bayer HealthCare AG, Leverkusen, Germany for Bayer Pharmaceuticals Corporation, West Haven, Conn. and by Onyx Pharmaceuticals, Inc., Emeryville, Calif.

Watching what you eat and getting regular exercise are important to your health. And this advice is especially important if you’re a cancer survivor according to a new report.

If you’re a cancer survivor, living a healthy lifestyle should be a top priority.

“Our message to cancer survivors, absolutely, is eating well, being active is really important to get you through cancer treatment and certainly as you look forward to that life beyond cancer,” Colleen Doyle of the American Cancer Society said.

The American Cancer Society’s new report finds that a healthy lifestyle will help patients feel better during treatment, and could reduce their risk of cancer coming back.

“There is much more evidence that being overweight, as a cancer survivor, has some really bad effects,” Doyle said. “In particular for breast cancer survivors, breast cancer survivors who are overweight at diagnosis or have gained weight after diagnosis are more likely to have cancer occurrence and also are more likely to die of that cancer.”

The cancer society’s best advice:

“Eat a wide variety of fruits and vegetables, eat a lot of whole grains, breads, cereals, pastas, cut back on high-fat meat, high-fat dairy products,” Doyle said. “Watch the amount of saturated fats you eat. These are the same type of things we tell anybody that is trying to improve their health and reduce their risk of chronic disease.”

African-American women with breast cancer were more likely to have larger, later-stage tumors that were more difficult to treat and also had lower survival rates than Hispanic and Caucasian women who received the same treatment in two independent series of clinical trials examined by researchers from The University of Texas M. D. Anderson Cancer Center.

The analysis published on line Oct. 23 by Cancer, a peer-reviewed journal of the American Cancer Society, indicates that race is associated with unfavorable tumor biology, which, along with other factors, likely contributes to the lower rate of breast cancer survival among African-Americans.

“These findings should prompt additional research on how we can improve outcomes for African-American patients by understanding and addressing tumor biology,” says first author Wendy Woodward, M.D., Ph.D., assistant professor of radiation oncology at M. D. Anderson. “It’s important to identify unique features in different populations and subgroups of all women with breast cancer so we can understand a woman’s risk and factors that affect her care on an individual level.”

African-American women are less likely than Caucasian women to have breast cancer but are more likely to die from it. Many factors have been implicated in this disparity, the researchers note, including access to health care and screening, differing treatments, socioeconomic status and racial bias.

By examining two series of clinical trials in which treatment was specified and rigorously followed for all patients, the research team minimized biases related to access to care and type of treatment, two variables that often confound analysis of the issue.

Between 1975 and 2000, 2,140 breast cancer patients were treated in two prospective series of clinical trials at M. D. Anderson involving use of the chemotherapy doxorubicin before and after a radical or modified radical mastectomy.

Of the total patients, 1,590 were Caucasian, 300 were Hispanic, and 250 were African-American, with racial categories based on self-reporting by the patients. In both trials, African-American women received at least as many cycles of chemotherapy as did Hispanics and Caucasians.

In the clinical trial for post-operative chemotherapy, the 10-year overall survival rate for African-Americans was 52 percent. For Hispanics and Caucasians it was 62 percent.

More African-American women came to the trial with later stage disease (24 percent compared with 18 percent of Hispanics and 16 percent of Caucasians) and tumors greater than 5 centimeters (22 percent compared with 13 percent each for Hispanic and Caucasians). African-Americans were more likely to have tumors that were estrogen-receptor negative, which are considered more difficult to treat (41 percent compared with 32 percent for Hispanics and 33 percent for Caucasians).

The trial of pre-operative chemotherapy showed similar results, with African-American 10-year survival rate of 40 percent, compared with 56 percent for Hispanics and 54 percent for Caucasians. As in the post-operative trial, higher percentages of African-Americans came to the trial with later-stage disease, larger tumors, and estrogen-receptor negative disease.

A multivariable analysis that took into account age, estrogen receptor-negative status, primary tumor size, and whether the disease had spread to the lymph nodes, showed that African-American race is an independent factor in reduced overall survival rate.

The researchers note they could not take into account factors that might have influenced the patients’ care before they entered the clinical trials. And their analysis did not include socioeconomic factors because that information was not available for patients. However, they doubt socioeconomic factors could fully explain differences in survival rate because Hispanic and African-American women have similar socioeconomic status in M. D. Anderson’s patient referral area.

“We interpret these data as suggesting that intrinsic biological differences in the disease and response to treatment among racial groups contributed to the poorer overall survival rates seen in the African-American cohorts,” the researchers conclude.

“It’s important to note that African-Americans, and people in all self-reported racial groups, are genetically and culturally diverse,” Woodward says. “Not all African-American women will have worse survival prospects for breast cancer, but there are probably subsets of patients for whom we could be doing something better.

“The tools and technology are emerging that will allow us to understand how one person’s tumors differ from another and how we can more effectively assign people to treatments,” Woodward says.