Christina Applegate Chose Breast Reconstruction, So How Come Other Women Don’t?

By Anne Krueger

Sunday night, actress Christina Applegate stood in front of a crowd of her peers and millions of viewers at the 60th annual Emmy Awards. And I couldn’t help wondering, how many of them were looking at her chest?
After the 36-year-old star of Samantha Who? had a prophylactic double mastectomy, she told Good Morning America that she would be undergoing reconstruction over the next several months.
I sat in on a Web seminar last week to learn about the latest developments in breast reconstruction, and I was surprised to learn how few women actually choose it even though the technique is improving all the time.
To find out about Christina’s surgery, the latest breast reconstruction advances, and why some women don’t opt for it, please read this week’s post in Health.com’s Breast Cancer Journey.

Should Women With Breast Cancer Be Guinea Pigs?

By Anne Krueger

If you’re a reader of this blog, you know I’m all for women’s rights, whether it’s the right to go braless or even topless. This week I’m standing up for an even more serious subject: a woman’s right to be a guinea pig.

To learn about the important role of clinical trials in breast cancer treatment, please read this week’s post in Health.com’s Breast Cancer Journey, where you can also find comprehensive breast cancer information on everything from getting the correct diagnosis to minimizing the effects of treatment on your appearance.

Go to this week’s post on clinical trials and breast cancer treatment.
Read all of Anne’s past Boob Blog posts here.

Cancer Survival Depends on Where You Live

(HealthDay News) -- Your odds of surviving cancer depend on which country you live in. And, in the United States, it also depends on whether you're black or white, a new study finds.

Economic differences among countries, access to health care, and the availability of cancer treatments feed the disparities in survival, the report said.

"There is a very wide global range in the odds of survival after a cancer diagnosis," said lead researcher Michel Coleman, a professor of epidemiology at the London School of Hygiene and Tropical Medicine in Great Britain. "Some of the range is understandable on the basis of the relative wealth of these countries," he added.

The study also confirms the disparity in cancer survival among blacks and whites in the United States, Coleman said. "The differences are large across the U.S.A., and even in different metropolitan areas," he said.

Coleman believes the differences among countries -- and within regions of countries -- is directly related to access to health care. "This is not a question of the competence of doctors in any particular country," he said. "This is an issue of the overall effectiveness of health services."

The report was published in the July 17 online edition of The Lancet Oncology.

For the study, called the CONCORD study, Coleman's team collected data on 1.9 million cancer patients in 31 countries. Using cancer registries from each country, the researchers compared the five-year survival rates for breast, colon, rectal and prostate cancer.

The United States has the highest rates of survival for breast and prostate cancers, while Japan has the highest survival rates for colon and rectal cancers among men. France has the highest survival rates for colon and rectal cancer among women, the report found.

In addition, Canada and Australia also have very high survival rates for most cancers. The lowest rate of survival among both men and women was seen in Algeria.

In the United States, the lowest survival rates are in New York City, except for rectal cancer in women, where Wyoming scores worse. The best survival rate for cancer in the United States is in Hawaii, the researchers found.

Idaho also has a high survival rate for rectal cancer, and Seattle has the highest survival rate for prostate cancer.

But, there's a big disparity in cancer survival rates between whites and blacks in the United States, and it favors whites. The differences range from 7 percent for prostate cancer to 14 percent for breast cancer. This disparity is most likely due to differences in the stage of cancer when it is diagnosed, the researchers said.

There's also a significant difference in cancer survival rates between the United States and Europe, with survival rates 10 percent and 34 percent higher in the United States for breast cancer and prostate cancer, respectively, the study found.

In Europe, France has the highest survival rate for rectal and colon cancers. Sweden has the highest survival rate for breast cancer, and Austria has the highest survival rate for prostate cancer.

The worst performing European countries are Poland and Slovakia.

Coleman said he hopes that political leaders will use the findings to provide better cancer diagnosis and treatment.

"Where the system is either slow in diagnosis, has too few doctors, has very few radiotherapy machines or in some countries, none, you would expect differences in outcome, and that's what these overall survival estimates are helping us provide," he said.

Dr. Elmer Huerta, president of the American Cancer Society's National Volunteer Board of Directors, said the study provides evidence for what has long been suspected -- namely, that where you live plays a role in cancer survival.

"The world needs to wake up to the fact that cancer is the second leading cause of death all over the place," he said. "Policymakers don't really put the weight to cancer care."

Huerta thinks more emphasis needs to be placed on the prevention, diagnosis and treatment of cancer.

"The world needs to smell the coffee and realize cancer can be prevented, and cancer can be cured if found early," he said.

More information
For more on cancer, visit the American Cancer Society.

Doctor-Patient Talks Affect Use of Breast Reconstruction Surgery

(HealthDay News) -- A lack of patient-doctor discussion may contribute to socioeconomic, age and race-related disparities in the use of breast reconstruction after mastectomy, says a study by researchers at Brigham and Women's Hospital and the Dana-Farber Cancer Institute in Boston.

The study also found that breast reconstruction was more likely to occur after a surgeon discussed options with a patient, which suggests the need to increase and improve these conversations, the researchers said.

They analyzed data on 626 patients who underwent mastectomy for breast cancer. Of those patients, 253 (40.4 percent) received breast reconstruction, and 249 (39.8 percent) had a documented discussion about the option with a doctor.

About 70 percent of those who had a discussion about breast reconstruction had the procedure. But the researchers found that increasing age and lower levels of education were associated with lower rates of a documented discussion. Hispanic patients, those born outside of the United States, and those whose primary language wasn't English were less likely to undergo reconstruction after discussing it with a doctor.

The study was published in the April issue of the Journal of the American College of Surgeons.

The decision to have breast reconstruction is a complex one that's influenced by access to care, patient preference and a doctor's interaction with the patient, the researchers noted.

"Patient preferences should be respected, but an informative discussion of reconstruction is required to help patients understand and weigh the risks and benefits of this procedure," Dr. Caprice C. Greenberg, Instructor of Surgery in the Center for Surgery and Public Health at Brigham and the Center for Outcomes and Policy Research at Dana Farber, said in a prepared statement. "We learned that physicians need to improve communications with all women undergoing a mastectomy, regardless of age, race or socioeconomic status."

She and her colleagues said doctors should systematically address the issue of breast reconstruction with all patients undergoing mastectomy. Doctor-patient discussions could include interpreters and educational materials to ensure an informative discussion regardless of a patient's primary language, ethnicity or education level.

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Terriers Join Fight Against a Killer Disease in Humans

(HealthDay News) -- A feisty breed of terrier could stop scientists from barking up the wrong tree as they research a deadly lung disease in humans.

The illness, called idiopathic pulmonary fibrosis (IPF), affects 128,000 Americans, is typically fatal within three years of diagnosis, and kills more than 40,000 people in the United States annually -- a death toll equivalent to that of breast cancer.

A fatal condition that looks remarkably like IPF also strikes the diminutive West Highland White terrier ("Westie"), however. And recently, medical scientists from the human and veterinarian worlds met for the first time to share information and pool resources against a mysterious killer.

"People may be a little startled at first to learn about this idea -- 'You're kidding me, you actually think there's promise in studying this dog to help my Dad with this disease?' And the answer is -- 'Yes'," said Mark Shreve, chief operating officer of the patient advocacy group Coalition for Pulmonary Fibrosis, based in San Jose, Calif.

Because the Westie is so tightly bred, and because the illness progresses faster in dogs than humans, it is conceivable that dog-based research might yield valuable clues to the genetics or environmental factors that trigger pulmonary fibrosis in both species, experts explained.

"And if it transpires that it is the same disease, then obviously the options are limitless as to how we can look at information from dogs and use it to understand the disease in humans and vice versa," said Dr. Brendan Corcoran, director of the Hospital for Small Animals at the University of Edinburgh, Scotland, and a pioneer in researching pulmonary fibrosis in Westies.

According to Shreve, most people find it hard to believe that a disease like IPF even exists amid the wonders of modern medicine.

"We are dealing here with one of the few diseases left on the planet for which there are no proven causes and no treatments," he said.

Idiopathic pulmonary fibrosis occurs spontaneously, although certain factors -- such as smoking or exposure to airborne toxins -- do raise risks for the illness. "IPF is a progressive scarring process in the lungs that gradually robs a person of the ability to breathe," Shreve explained.

Some sort of signaling seems to go awry at the cellular level, he said, converting normal, expansive lung tissue into stiff, fibrotic scar tissue.

"Once it starts in patients with IPF, your body just never sends a signal to stop that scar tissue from being produced," Shreve said. "This scar tissue is obviously not lung tissue that is able to process oxygen."

There have so far been very few promising leads in discovering the root causes of IPF, said Dr. Jesse Roman, one of the country's leading researchers in the disease and a professor of medicine at Emory University in Atlanta.

"Studies do suggest very specific [cellular] pathways, and there's a number of molecules that everybody is tuned into," he said. "But how you block them and how they relate to what happens in humans, that's less clear."

So, scientists are turning to creative new ways of looking at IPF.

Cross-talk between scientists worldwide led to the first-ever summit on the disease that included both veterinary and human medical researchers. The meeting was held in October on the campus of Purdue University in West Lafayette, Ind., and was attended by Corcoran, Roman and others. It was sponsored by the Westie Foundation of America and the American Kennel Club (AKC) Canine Health Foundation.

Westies, which grow to just under a foot in length, are described by the AKC as "courageous and self-reliant, but friendly."

"They're a very popular pet because of their size and their nature," Corcoran said.

However, pulmonary fibrosis does pop up in the breed with regularity, first revealing itself as excessive panting and shortness of breath. The illness also tends to develop in the terriers' late middle-age (about eight or nine years), mimicking its typical onset in humans at about age 50 to 60.

Westies inevitably succumb to the lung fibrosis about a year and a half after their diagnosis, Corcoran said.

Still, "there's still the contentious issue of whether this is the same disease as occurs in humans," he said. The exact prevalence of the disease among Westies is also unclear, he added. That means the first aim of Westies-centered research will be epidemiological -- studying disease prevalence and gathering a core of dogs and their owners that researchers might follow going forward.

Getting postmortem samples of canine lung tissue will also be crucial to a better understanding of the causes of the disease, Corcoran said. But that has its own challenges, he added.

"Getting owners to volunteer their dogs for necropsy is always problematic," he said. In fact, it's often "harder in many instances to get lung pathology samples from dogs than it is from humans," Corcoran said.

"However, one of our plans is to try and build up a group of concerned owners who will volunteer to donate their dog when that day arrives. We've been having some discussions on that already with our colleagues in America," Corcoran said. "Hopefully, the more publicity that we get with this condition, the more we may get owners coming forward and volunteering their dogs for research."

Corcoran and the other experts said that a cure for IPF is definitely not around the corner -- the disease has been as tenacious in keeping its secrets as, well, a terrier.

But Westies may be just the foe in the fight against IPF requires. Corcoran pointed out that the dogs' tight breeding means genetic research could yield important clues. And their shorter lifespan -- a seventh of that of humans -- means scientists can watch the disease in "fast-forward," which might also speed research.

Westies are also free of certain confounding factors, such as smoking, that often muddle human research. "The dogs might turn out to have a very pure form of the disease that allows you to investigate the disease itself and not worry about other factors," Corcoran noted.

Given all of this, "why wouldn't you look at a Westie and research how the disease progresses?" said patient-advocate Shreve.

"We think it's a very creative approach to trying to help out humans," he said, "and our patients don't really have the patience to hang around waiting for a miracle.

More information
To learn much more about IPF, visit the Coalition for Pulmonary Fibrosis.

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Cancer Killed Almost 8 Million Worldwide in 2007

(HealthDay News) -- Cancer continues to cut a deadly swath across the globe, with the American Cancer Society reporting 12 million new cases of malignancy diagnosed worldwide in 2007, with 7.6 million people dying from the disease.

The report, Global Cancer Facts & Figures, finds that 5.4 million of those cancers and 2.9 million deaths are in more affluent, developed nations, while 6.7 million new cancer cases and 4.7 million deaths hit people in developing countries.

"The point of the report is to promote cancer control worldwide, and increase awareness worldwide," said report co-author Dr. Ahmedin Jemal, director of the society's Cancer Occurrence Office.

The number of cancers and cancer deaths around the world is on the rise, Jemal said, mostly due to an aging population. "There is increasing life expectancy, and cancer occurs more frequently in older age groups," he noted.

Lifestyle may be another reason for the rise in malignancies in developing countries, Jemal said, as people adopt Western behaviors such as smoking, high-fat diets and less physical activity.

The best way to stem the increasing number of cancer cases and deaths is prevention, especially in poorer countries, the expert said. In many developing nations, the health-care infrastructure simply isn't there to offer cancer screening and treatment for most people, Jemal added.

In developed countries, the most common cancers among men are prostate, lung and colorectal cancer. Among women, the most common cancers are breast, colorectal and lung cancer, according to the report.

However, in developing countries the three most common cancers among men are lung, stomach and liver, and among women, breast, cervix uteri and stomach.

Worldwide, some 15 percent of all cancers are thought to be related to infections, including hepatitis (liver cancer) and human papilloma virus (cervical cancer). But the incidence of infection-related cancers remains three times higher in developing countries compared with developed countries (26 percent vs. 8 percent), according to the report.

In addition, cancer survival rates in many developing countries are far below those in developed countries. This is mostly due to the lack of early detection and treatment services. For example, in North America five-year childhood cancer survival rates are about 75 percent compared with three-year survival rates of 48 percent to 62 percent in Central America, the report notes. The report estimates that 60 percent of the world's children who develop cancer have little or no access to treatment.

The report also includes a section on the toll tobacco use takes around the world. In 2000, some 5 million people worldwide died from tobacco use. Of these, about 30 percent (1.42 million) died from cancer -- 850,000 from lung cancer alone.

Jemal believes smoking is a key culprit.

"Smoking prevalence is decreasing in developed countries. So, as tobacco companies are losing market in developed countries they are trying to expand their market in developing countries," he said.

In China alone, more than 350 million people smoke. "That's more than the entire population of the United States," Jemal said. "If these current patterns continue, there will be 2 billion smokers worldwide by the year 2030, half of whom will die of smoking-related diseases if they do not quit," he added.

In the 20th century, tobacco use caused about 100 million deaths around the world. In this century, that figure is expected to rise to over 1 billion people. Most of these will occur in developing countries.

One expert agreed that many cancer deaths can be avoided through lifestyle changes.
"What is most provocative here is not the total global burden of suffering and death cancer causes, dramatic though that may be, but the variations in cancer occurrence around the world, and the insights provided about how much of the cancer burden need not occur at all," said Dr. David Katz, director of the Prevention Research Center at Yale University School of Medicine.

In developing countries, cancer of the uterine cervix is a leading cause of death in women, Katz noted.

"Yet this infection-related cancer is now preventable by vaccine, and long treatable when detected early using the Pap smear. As a result, death from cervical cancer in developed countries is dramatically lower. Its toll in the developing world is testimony to missed opportunities to apply our resources effectively, and equitably," he said.

Cancer of the liver, often related to hepatitis infection, is a leading cause of death in developing countries, but not so in developed countries. "Again, an infection preventable with vaccine is causing death because of inequities in the distribution and use of existing resources," Katz said.

Prostate and colon cancers are more common in wealthier countries, where they are likely related to poor diet and obesity, Katz said. "Unnecessary suffering and death are occurring in affluent countries due to dietary excesses," he said.

Katz also noted that tobacco-related cancer is largely preventable. "The toll of tobacco-related disease, including lung cancer, is an appalling example of a global willingness to tolerate preventable suffering and death for the sake of profit," he said.

These data show both developed and developing countries how to move toward the lower rates of specific cancers, Katz said.

"It will be a tragic failure for public health if instead of applying these lessons developed countries continue to export tobacco and dietary transgressions so that the developing world adds to its current cancer burden ours as well," he said.

More information
For more information on cancer, visit the American Cancer Society.

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Cell Insights May Predict Breast Cancer's Spread

(HealthDay News) -- U.S. researchers believe they're on the way to solving a major question about breast cancer: Which women have a type of lesion in their breast duct that will progress to invasive disease?

"It's an exciting step forward -- people have been trying to get traction on this big clinical problem for about 40 years, and this is a big crack in the door," said lead researcher Thea Tlsty, a professor of pathology at the University of California, San Francisco.

Ductal carcinoma in situ (DCIS), as this type of lesion is officially known, is diagnosed in about 47,000 American women every year, according to the U.S. National Cancer Institute. To prevent its recurrence as invasive breast cancer, DCIS generally is treated by lumpectomy alone (approximately 25 percent of cases) or lumpectomy with adjunctive treatments such as radiation, chemotherapy, and/or hormones (approximately 40 percent).

In about 25 percent of cases, complete mastectomies are performed. Less than an estimated 5 percent of women choose "watchful waiting" in lieu of a surgical intervention, Tlsty said.

But doctors are still confronted with a guessing game when it comes to predicting those patients at highest risk for recurrence, Tlsty said. "Only about 12 to 15 percent of women diagnosed with DCIS are going to have a future invasive cancer, and all the others won't. Up until now, the problem was that we couldn't distinguish the 12 to 15 percent from those who were not [at risk]," explained Tlsty.

Consequently, some women unknowingly are overtreated by having a mastectomy, and others are undertreated if they chose a course of watchful waiting rather than surgical intervention, Tlsty added.

In their pilot study, published in the November issue of Cancer Cell, the UCSF team looked at how a collection of biomarkers, including molecules called p16 and ki67, interact to predict invasive tumors, she explained.

Because this initial study was done on tissue samples from 70 women, a larger retrospective study is under way at UCSF to validate the initial results, Tlsty said.

Further research, including a large prospective trial, is also needed before the findings can be ready for clinical use, she added. If that work upholds the results of the pilot study, the biomarkers could be ready for clinical use within four to five years, Tlsty said.

Dr. Joseph Geradts, a professor of pathology at Duke University in Durham, N.C., said that finding biomarkers that predict the conversion of DCIS into invasive cancer is "the holy grail of breast cancer research." He said there have been a number of previous studies that have been published, but, so far, they've been "mostly a fruitless effort."

According to Geradts, the UCSF study "is valuable," because "the authors propose two new biomarkers that in the past have not been looked at." The UCSF team's findings "are intriguing preliminary data" that "merit confirmation and subsequent studies," he added.

Geradts said his own lab currently is researching whether changes in DNA may identify a tumor's capacity to metastasize or become invasive. Other researchers are looking at other DCIS biomarkers, he said.

"DCIS itself is a non-life threatening condition" with rare exceptions, noted Dr. Eric Winer, director of breast oncology at the Dana-Farber Cancer Institute in Boston, and women are usually treated to help prevent invasive cancer. If the findings of the initial UCSF study are confirmed, then with "careful investigation, we may get to the point where we don't have to treat all women with DCIS, and we may be able to tailor it so some women get less, and some women get more" depending upon their risk for invasive breast cancer, Winer said.

"It's a very complex and interesting study" added Dr. Richard Bleicher, a surgical oncologist at Fox Chase Cancer Center in Philadelphia. "We need to be cautiously optimistic."

Bleicher added that while the findings have "significant potential," women at this point shouldn't "pin all your hopes on it," because the p16 assay is not something they can ask their doctors for at this point in time.

More information
For more on breast cancer, visit the U.S. National Cancer Institute.
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Pill Poses Little Cervical Cancer Risk

(HealthDay News) -- Women taking oral contraceptives are at a slightly increased risk for developing cervical cancer, but a decade after stopping the pill even this very small risk disappears, a new British study suggests.

However, that finding doesn't change the recommendation for women to continue getting screened for cervical cancer, experts say.

"This is good news," said lead researcher Dr. Jane Green, an epidemiologist in the Cancer Epidemiology Unit at the University of Oxford. "We have been able to estimate the lifetime risk of cervical cancer for women on the pill and find it's really quite small," she said.

"The small increase in cervical cancer we see in women who are taking oral contraceptives starts to fall once pill use stops and has really gone away by 10 years after stopping use," Green said.

"The pill has many other benefits, including reducing the risk of other cancers, such as ovarian cancer and womb cancer," Green added.

The report is published in the Nov.10 issue of The Lancet.

In the study, Green and her colleagues from the International Collaboration of Epidemiological Studies of Cervical Cancer collected data on almost 16,600 women with cervical cancer and more than 35,500 women without cervical cancer. These women had participated in a total of 24 studies.

Green's team confirmed that the risk of cervical cancer among women who use oral contraceptives does increase over time. But this increase in risk is very small -- women who take contraceptives for five years or more have only about twice the risk compared with women who never took the pill.

In absolute terms, that means that a 20-year-old woman living in a developed country who uses an oral contraceptive for 10 years increases her odds of developing cervical cancer by age 50 from 3.8 cases per 1,000 women (without Pill use) to 4.5 per 1,000 women after using oral contraception. In less developed countries, where access to cervical cancer screening is more limited, that risk rises from 7.3 to 8.3 cases per 1,000 women, the researchers estimated.

Similar risk was seen for invasive and localized cancer and in women who have the human papillomavirus (HPV), which causes about 70 percent of all cervical cancers, Green noted.
Although the risk for cervical cancer associated with the Pill is small, Green advised women to still be screened for the disease. "Screening for cervical cancer is effective," she said. "The advice is to go for regular screenings."

Eventually, Green hopes that the vaccination against the human papillomavirus will go a long way to preventing many cases of cervical cancer.

One expert agreed that the findings showed the risk for cervical cancer from oral contraceptives was very small.

"This is reassuring news for women," said Dr. Peter Sasieni, from the Wolfson Institute of Preventive Medicine at Queen Mary University of London and author of an accompanying journal comment. "There is really a minimal risk from oral contraceptives, and that risk disappears fairly soon when you stop taking them," he said.

"When making a decision about what from of contraception to use, women shouldn't worry about cervical cancer," Sasieni concluded. "It's not an issue," he said.

However, he believes that taking oral contraceptives is another good reason to get screened regularly for the disease. "By going for regular screenings, a women can reduce her risk by 80 percent," Sasieni said.

Another expert agreed that women shouldn't worry about the Pill and cervical cancer risk.
"I don't think women are basing their decision of which form of contraception to use on the risk for cervical cancer," said Debbie Saslow, director of breast and gynecologic cancer at the American Cancer Society. "People who want to use oral contraceptives should not be alarmed over the slight increase in cervical cancer risk," she said.

However, women -- whether they take oral contraceptives or not -- should be getting regular cervical cancer screening, Saslow said.

More information
For more on cervical cancer, visit the American Cancer Society.
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Precancerous Lesions Raise Cervical Cancer Risk

(HealthDay News) -- Women who have had advanced precancerous lesions of the cervix are still at risk for invasive cancers up to 25 years later, Swedish researchers report.

Currently, the American Cancer Society recommends that women who have had precancerous lesions called severe dysplasia/carcinoma in situ (CIS) continue getting Pap tests for 10 years after treatment. But, based on this study, these guidelines may need to be changed, said Debbie Saslow, the society's director of breast and gynecologic cancer, who was not involved with the research.

Saslow added, however, that even though these women continue to be at risk for developing cervical or vaginal cancer, the risk is low. "Women who have been treated for advanced precancer do need to remain vigilant," she said.

"This paper is going in my file for when we update our guidelines in the next two years," Saslow added. "We will see if we want to stick with 10 years or go to a much wider interval."

The study was led by Dr. Bjorn Strander, a senior consultant with the Department of Obstetrics and Gynecology at Sahlgren's Academy at the University of Gothenburg. The researchers collected data on 132,493 women who had a diagnosis of severe dysplasia/CIS between 1958 and 2002. The statistics came from the National Swedish Cancer Register.

The researchers found 881 women had developed cervical cancer, and 111 had developed vaginal cancer more than one year after the initial diagnosis. This was almost seven times higher than expected, the researchers said.

Women with a diagnosis of severe dysplasia/CIS were more than twice as likely to develop cancer compared with the general female population. The women were also twice as likely to develop invasive cervical cancer after diagnosis of CIS if that diagnosis was made between 1991 and 2000, compared with the same diagnosis made from 1958 to 1970. This increased risk might be due to changes in treatment over that period, particularly because fewer hysterectomies are being done as part of treatment for CIS, the study authors said.

Strander's team also found a particularly high risk for women over age 50, and this risk continued to increase with age. "The risk after treatment hardly decreases at all after treatment and is still sustained after more than 25 years," he said.

"While well-screened women after 50 to 60 years of age are very well protected from cervical cancer and have little, if any, further use of screening, this does not apply to women who have been treated for grade 3 CIS," Strander said. "They need, and should have, long-term follow-up, perhaps lifelong," he said.

The results are published in the Oct. 26 edition of the British Medical Journal.

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For more on cervical cancer, visit the American Cancer Society.
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Best Breast-Cancer Care Eludes Older Women

(HealthDay News) -- As women live longer lives, the number of breast cancer cases among older patients is rising, too.

Yet many older women are being under-diagnosed and under-treated for the disease, studies show. Often, age -- rather than health status -- is the deciding factor in determining how to care for the 80-and-older set.

"I think that the biggest problem to this point has been physicians' and patients' attitudes toward treatments," said Dr. David A. Litvak, a general surgeon and surgical oncologist for the Permanente Medical Group in Southern California.

Patients, on one hand, often have misconceptions about what the treatment involves. "They think it's going to be too disruptive to their daily lives," Litvak said. On the other hand, a lot of physicians have biases about treating anyone over 80, he added. Their thinking is, "How much time could they possibly have left?" As a result, many doctors assume a "leave-them-alone sort of attitude," he said.

Litvak led a study examining the medical records of 354 women, 70 and older, who were diagnosed with breast cancer at a community hospital in Michigan between 1992 and 2002. The study was published recently in the Archives of Surgery.

In all, 46 percent of the women had breast cancer that doctors could detect during a physical examination. Even though 72 percent of the women had mammograms, those tests were given mainly to verify the physical exams.

Seventy percent of the women were diagnosed when their cancer was in the early stages. But 36 of the women overall, and 56 percent of those 80 and older, were never closely evaluated to see whether the cancer had spread to their lymph nodes.

The study also revealed lapses in treatment. About half of the women had breast-conserving surgery, but fewer than expected received chemotherapy, radiation and hormonal therapy after surgery, and the rates of treatment were lowest among the oldest women.

The findings add to a growing body of medical literature examining the under-treatment of older breast cancer patients.

Dr. Rebecca Silliman, a professor of medicine and public health at Boston University and chief of the geriatric section at Boston Medical Center, noted that she and others have been reporting on this gap in care for many years. As a co-author of a recent article in the journal Cancer, she and her colleagues have even linked under-treatment to a higher risk of breast cancer recurrence in older women.

"What is really needed is better evidence for treatment efficacy in this age group, plus more accurate strategies for identifying those at risk of bad outcomes and matching treatment intensity to risk," she said. "This isn't being done as well as we would hope."

Dr. Arti Hurria, director of the aging and cancer research program at City of Hope in Duarte, Calif., is leading an effort to develop a geriatric assessment tool to improve the ability to predict how an older breast cancer patient will tolerate certain treatments and what the benefits of treatment will be.

"We've developed a geriatric assessment that's feasible to do within daily practice, and now we're looking to see how does the assessment predict how an individual will do if they receive a certain treatment, or if they don't," she said.

The tool is simple enough that most patients can provide the information themselves and complete the survey in less than 30 minutes, Hurria said. It asks about a patient's activity level, medical problems, social support, nutritional status, and psychological state, among other things.

The assessment seeks to gather information about a woman's life expectancy, tolerance to treatment and access to support systems that may be necessary to get through therapy, Hurria said.

For example, she explained, "If they don't have social support, can we get a visiting nurse in? If they are feeling depressed and anxious, should we be getting some physiological support as part of the treatment plan?"

Litvak supports geriatric assessments as a way to get past age discrimination. "We should be changing our way of treating older patients and not have absolute cutoffs for age," he said.

More information
Read the American Geriatrics Society's position statement on breast cancer screening for older women.

Experts Offer Tips on Lung Cancer Prevention

(HealthDay News) -- People, especially smokers, should not rely on vitamin and mineral supplements to prevent lung cancer, say members of the American College of Chest Physicians in their second annual guide to lung cancer prevention, care and treatment.

The new evidence-based guidelines also include a strong statement opposing the use of low-dose CT scans for the general screening of lung cancer.

Lung cancer is the leading cause of cancer death in the United States. More people die from lung cancer than from colon, breast, prostate and pancreatic cancer combined.

"Each year, great strides are made in the diagnosis and treatment of lung cancer, allowing patients with the disease to live longer and increase the quality of their lives. However, the real culprit behind lung cancer is tobacco," Dr. Mark J. Rosen, president of the American College of Chest Physicians (ACCP), said in a prepared statement. "Avoiding tobacco is the key to preventing most forms of lung cancer. Until we eliminate tobacco use completely, we will continue to deal with its devastating health consequences."

Published as a supplement to the September issue of the college's journal Chest, the guidelines note there is little evidence to show lung cancerscreening changes the outcome for patients, including those considered to be at high risk.

"Even in high-risk populations, currently available research data do not show that lung cancer screening alters mortality outcomes," Dr. W. Michael Alberts, chairman of the ACCP lung cancer guidelines, said in a prepared statement. "We hope that, one day, we can find a useful and accurate tool for general lung cancer screening but, at this time, the evidence does not support the use of LDCT screening."

This is the second edition of Diagnosis and Management of Lung Cancer: ACCP Evidence-Based Clinical Practice Guidelines. The guide contains 260 recommendations, including a review of complementary and integrative therapy for the prevention and treatment of lung cancer.

Due to the lack of supporting evidence, the guidelines recommend against the use of LDCT, chest X-rays or single or serial sputum cytologic evaluation for lung cancer screening in the general population, including smokers or others at high risk. The exceptions are for patients in well-designed clinical trials.

"Population screening for lung cancer is not recommended and may, ultimately, put the patient at risk for further complications," Dr. Gene L. Colice, vice chairman of the ACCP lung cancer guidelines, said in a prepared statement. "Nodules are commonly found during screening; however, to determine whether they are cancerous requires additional testing, which is fairly invasive and extensive. This may cause the patient needless risk, both physically and psychologically."

In terms of prevention, the guidelines recommend against the use of several common supplements and medications in at-risk patients or those with a history of lung cancer.

Beta carotene tops the list of supplements that the ACCP recommends against. According to the data, there is a actually a higher incidence of lung cancer in people who use these supplements.

Other supplement recommendations:
Vitamin A, including isotretinoin, has not been shown to decrease the number of second tumors and actually increases the risk of early death for current smokers.

Vitamin E is not recommended for lung cancer prevention, as studies show that there is no difference in the occurrence of lung cancer between people taking vitamin E and those who are not.

Aspirin has been shown in some studies to play a protective role, but the guidelines do not recommend aspirin for preventing lung cancer. Studies show aspirin does not decrease the risk of death or lung cancer incidence.

This is also the first edition of the guidelines to include recommendations on techniques that can help reduce the anxiety, mood disturbances and chronic pain associated with cancer.
Massage therapy is recommended as a way to reduce anxiety and pain.

Acupuncture is recommended for patients experiencing fatigue, dyspnea and chemo-induced neuropathy. Acupuncture is also recommended for people whose nausea, vomiting or pain is poorly controlled.

Electrostimulation wristbands are not recommended for managing chemo-induced nausea or vomiting. Studies show they do little to delay nausea or vomiting.

A multidisciplinary group of 100 pulmonologists, medical oncologists, radiation oncologists, thoracic surgeons and other health professionals reviewed the 260 recommendations.

More information
To learn about lung cancer, visit the U.S. Centers for Disease Control and Prevention.

Many Parents Share Genetic Test Findings With Kids

(HealthDay News) -- As genetic testing for diseases becomes more commonplace, the impact of those findings on family members may be underestimated, researchers say.

For instance, some women who discover they have the BRCA gene mutation, which puts them at higher risk for breast cancer, choose to tell their children about it before the children are old enough to understand the significance or deal with it, a new study found.

"Parents with the BRCA mutation are discussing their genetic test results with their offspring often many years before the offspring would need to do anything," said study author Dr. Angela Bradbury, director of the Fox Chase Cancer Center's Family Risk Assessment Program, in Philadelphia.

According to Bradbury, more than half of parents she surveyed told their children about genetic test results. Some parents reported that their children didn't seem to understand the significance of the information, and some had initial negative reactions to the news.

"A lot of genetic information is being shared within families and there hasn't been a lot of guidance from health-care professionals," Bradbury said. "While this genetic risk may be shared accurately, there is risk of inaccurate sharing."

In the study, Bradbury's team interviewed 42 women who had the BRCA mutation. The researchers found that 55 percent of parents discussed the finding and the risk of breast cancer with at least one of their children who was under 25.

Also, most of the women didn't avail themselves of the services of a doctor or genetic counselor in helping to tell their children, Bradbury's group found.

Bradbury is concerned that sharing genetic information with young children can create anxiety. "The children could be overly concerned about their own risk at a time when there is nothing that they need to do," she said.

But, she added, "it may be possible that sharing may be good for children in adapting to this information."

The findings are published in the Aug. 20 issue of the Journal of Clinical Oncology.
The lack of definitive data on when -- or if -- to discuss genetic test results with children is a real problem, Bradbury said.

"As we move genetic testing forward for cancer or other illnesses, we have to consider the context of the whole family and focus our counseling to the whole family, and not just the person who comes in for testing," Bradbury said. "We should learn more about how and when we should talk to children about this, so that we can promote healthy behaviors without causing too much anxiety for the offspring."

Barbara Brenner, executive director of Breast Cancer Action, agreed that the psychological component of genetic testing needs more attention.

"This is the tip of a very scary iceberg," Brenner said. "We don't know the psychological consequences [of BRCA testing], not only to the person who has the test, but to her family members."

Brenner thinks guidelines to help parents deal with this information are needed. So is help from doctors and genetic counselors in counseling family members, especially children, she added.

More information
For more on genetic testing, visit the U.S. National Library of Medicine.

Hormone Therapy Extends Lives of Ovarian Cancer Patients

(HealthDay News) -- Hormone therapy that has proved successful against breast cancer may also extend and improve the lives of women with estrogen-sensitive ovarian cancer, a British study suggests.

Letrozole hormone therapy may also be an alternative to chemotherapy for some women with the disease, according the report in the June 15 issue of Clinical Cancer Research.

"This study demonstrates that some ovarian cancers are responsive to anti-estrogen hormonal therapy, and these cancers, and therefore the patients who would benefit, can be identified," said lead researcher Simon Langdon, a Cancer Research UK scientist and a senior lecturer in cancer research at the University of Edinburgh.

Langdon noted that his team's research has shown that growth of certain ovarian cancers is stimulated by the female hormone estrogen. "These cancers could be identified as those possessing high levels of the estrogen receptor," he said.

For the study, which included 44 women, the researchers used letrozole, which works by limiting production of estrogen in the body. "This treatment then effectively starves the ovarian cancer of estrogen and inhibits growth," Langdon said.

During six months of treatment, 25 percent of the women had no tumor growth, and 33 percent of the women with the greatest estrogen values had a positive response that delayed the use of chemotherapy. "Within the trial, we were able to show that tumors with the highest levels of estrogen receptor were the most likely to respond to treatment," Langdon said.

"This approach provides an addition to chemotherapy for this disease," he added. "It is unlikely to replace chemotherapy but could be used to delay the need for chemotherapy."

The patients most likely to benefit from the therapy can be identified before treatment starts. So, this kind of approach means women can be better targeted and the drug not given to those unlikely to benefit who should receive some other type of treatment, Langdon said.

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The American Cancer Society reports that ovarian cancer is the eighth most common cancer in women, not including skin cancer. There will be about 22,430 new cases of ovarian cancer in the United States this year, and an estimated 15,280 women will die from the disease.

A large majority -- about two-thirds -- of women with ovarian cancer are 55 or older. A woman's risk of getting ovarian cancer is about one in 67, according to the cancer society.

Dr. Len Lichtenfeld, the deputy chief medical officer at the American Cancer Society, said, "Letrozole is already approved for treating ovarian cancer in women who have failed other treatment. This study refines these researchers' previous work by identifying those women with estrogen-receptor-sensitive ovarian cancer who are the most likely to respond to this drug.

"Whether the drug should be started earlier in the course of ovarian cancer and whether we should be evaluating whether or not a woman has estrogen-receptor-sensitive ovarian cancer are questions that need to be answered," he said.

More information
For more information on ovarian cancer, visit the American Cancer Society.

New Study Stresses Mammogram's Importance in Breast Cancer Decline

(HealthDay News) -- The decline in U.S. breast cancer cases is caused not only by fewer women using hormone replacement therapy but also by the use of mammography screening, new research suggests.

"Two distinct patterns are observed in breast cancer trends," wrote Dr. Ahmedin Jemal, strategic director for cancer surveillance for the American Cancer Society, in a report published in the May 3 online edition of the journal Breast Cancer Research.

After colleagues presented an abstract at a breast cancer symposium that attributed the 7 percent decline in U.S. breast cancer cases in the years 2002 to 2003 to the reduced use of hormone replacement therapy, Jemal's team decided to look at an older data base.

The researchers who linked the decline to reduced hormone use looked at a large data base from 2002 and 2003 called SEER (Surveillance, Epidemiology, and End Results). In 2002, a large federally funded trial -- part of the Women's Health Initiative -- was halted when evidence emerged of an increased risk of heart disease and breast cancer due to hormone therapy.

After that, women in large numbers went off their hormone replacement regimens.

But Jemal's team looked at older SEER data bases, from 1975 to 2003. The researchers looked at breast cancer incidence rates by tumor size, tumor stage, and whether the tumor was estrogen-receptor positive or negative among women who were age 40 or older in the years studied.

They found that the decline in breast cancer cases also dropped prior to the 2002-2003 SEER data, although the decrease was less dramatic -- about 5 percent between 1999 and 2000 there was a 5 percent drop, according to Jemal.

"The point is breast cancer started to decrease before 2002," Jemal said. And screening mammograms were the reason, he added.

The decline in breast cancer rates directly attributed to mammography, he said, has now leveled off.

"The message for women over 40 is still, they should get a mammogram every year so the tumor [if there is one] can be detected," Jemal said.

The new study is "a more nuanced analysis," said Roshan Bastani, professor and associate dean for research at the University of California, Los Angeles, and associate director for cancer prevention and control at the university's Jonsson Comprehensive Cancer Center. "It shows there were declines in breast cancer that started before the recent declines."

While from a public health perspective a plateau may have been reached when it comes to the benefits of screening mammography, Bastani added, it's still crucial for women over age 40 to keep their mammogram appointments. "About 75 percent of [U.S.] women are getting screened. That has not changed since 1999," she said.

More information
To learn more about breast cancer, visit the American Cancer Society.

HEALTH EFFECTS OF XENOBIOTICS

We Are All Toxic!

There is not a person on this earth that does not have some hazardous chemicals in their tissues; exposure to them has been linked to several cancers and to a broad range of reproductive problems, including birth defects.

The increasing incidence of some of these conditions, and our continued exposure to a cocktail of these chemicals, is alarming. On of the patterns being observed in developed countries is the increase in chronic diseases associated with environmental factors: indeed, a quarter of all diseases have been attributed to environmental causes, and there can be little doubt that exposure to hazardous chemicals is one of them.

Hormone (or endocrine) disrupting chemicals inparticular pose a high risk to human welfare and are likely to be causing widespread harm. For example, some man-made chemicals have been linked with:

• a range of effects on the reproductive system including sperm quality and the incidence of male genital abnormalities;


• spontaneous abortion, premature deliveries and low birth weight;


• alterations in the ratio of male to female offspring; and
  delays in development of, and deficits in, the mental ability of children.


• In addition, some chemicals may play a role in certain diseases such as breast and testicular cancer.

It’s a Big Problem!

Global chemical production has escalated from around one million tonnes a year in 1930 to some 400 million tonnes in 2000. By the end of the 1990s, some 100,000 chemicals had been registered in the EU, of which 30,000 have annual production volumes above one tonne.

Synthetic chemicals can affect human biology in numerous ways. Many are carcinogens, others can cause birth defects, and still others can disrupt the hormone system. These chemicals, on the market today, can be found in everything from pesticides, paints and industrial detergents to cosmetics, furniture and hair dyes. Many of these xenobiotics were present in the September 9-11 calamity, as well as some of the other wars in the Middle East - polycyclic aromatic hydrocarbons (PAHs), polychlorinated biphenyls, polychlorinated dibenzodioxins, polychlorinated dibenzofurans, pesticides, phthalate esters, brominated diphenyl ethers, and other hydrocarbons.

Some accumulate over time and contaminate our water, soil and food, and some are transported long distances on air and ocean currents, so that they contaminate people living in remote areas as far away as the Arctic. Regulations have not kept up with the scale of chemical production. Most chemicals on the market and in everyday use have never been adequately assessed for their human and environmental safety. Of particular concern to World Wildelife Fund (WWF) are chemicals that are very persistent and bioaccumulative, and those that are capable of disrupting the normal functioning of the hormone (or endocrine) system.

Bioaccumulation of XenobioticsOur bodies build up over time very persistent and bioaccumulative xenobiotics – most of these will last many years and probably be one of the main causes of our mortality. This is really quite a new science as most of the toxic reference ranges set by most authorities are based on a one-dose toxic level, not on a bioaccumulative process - scientists must now put on their thinking caps and begin thinking laterally! It is probably a good idea to begin phasing these chemicals out NOW before they kill our grandchildren and great grandchildren!

Endocrine Disrupting Chemicals, Reproductive Problems & Obesity

Previous studies have found that exposure to phthalates—found in cosmetics, shampoos, soaps, lotions, lubricants, paint, pesticides, plastics and in the coating of some timed-release medicines - may be associated with reproductive problems. More than 75 percent of the United States population is thought to have measurable levels of several phthalates in their urine. Researchers have theorized that this class of chemicals, as well as other environmental pollutants, may be lowering testosterone levels in men and may be responsible for the substantial declines in testosterone levels and sperm quality that have occurred in the United States and other countries over the last several decades.

Animal studies have demonstrated that phthalates lower testosterone levels and recent human data has found that phthalates are associated with poor semen quality in men and subtle changes in the reproductive organs in male children. Researchers of the current study decided to investigate the effect of this class of chemicals on obesity after noting that low testosterone appears to cause increased abdominal fat and pre-diabetes in men.

Consequently, if phthalates cause a decrease in testosterone, they theorized, then it could also play a role in weight gain and insulin resistance. The scientists analyzed urine, blood samples and other data from subjects participating in the National Health and Nutrition Examination Survey, a large, multi-ethnic, cross-sectional sampling of the U.S. population conducted routinely by the Centers for Disease Control and Prevention.

After adjusting for confounding factors, the researchers discovered that there was a definite link between levels of several phthalate metabolites and abdominal obesity. Men who had the highest phthalate levels in their urine had more belly fat and a greater prevalence of insulin resistance compared to subjects with lower levels.

This is why it is important to detoxify on a regular basis, clean our liver and gallbladder as well as help to remove these phthalates and other xenobiotics or foreign chemicals – taking HMD can help this process -

Health Effects in Children

Children are exposed to more toxic chemicals in food, air and water than adults because relative to their size, they breathe twice as much air, eat three to four times more food, and drink as much as seven times more water. There is increasing scientific evidence that children face much higher cancer risks from exposure to environmental contaminants than adults.

Only last year, a US study showed that neonate cord blood contained an average of 287 chemicals, of which 180 of these were carcinogens. A similar study in neonates in the Inuit Eskimos living in the North Pole also showed arsenic, lead, mercury and organochlorine pesticides such as DDT which has been banned in the Western world for more than 20 years. This is why the statement “we are all toxic” can no longer be refuted.

Given this level of toxicity from the womb, it should be no surprise that there is a rise in childhood cancers, such as brain cancer, as well as in cancers such as non-Hodgkin’s lymphoma and multiple myeloma among adults. The risk of non-Hodgkin’s lymphoma has been linked to industrial chemicals used in dark hair dyes and the incidence of this disease was seven times greater in children whose parents frequently used home pesticides.

Neurological and Behavioural EffectsThere is evidence that children’s exposure to some man-made chemicals, especially PCBs, can affect their neurological development and mental ability. Xenobiotics commonly present in women, which are passed on to the developing foetus, can affect the behaviour and mental development of their children, particularly in early childhood. However, these effects may persist to such an extent that impaired reading ability and reduced IQs have still been found in American children aged 11. Man-made chemicals are also suspected of contributing to learning disabilities, including attention deficithyperactivity disorder (ADHD) and autism.

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Best wishes,© Dr. George J Georgiou, Ph.D.,ND.,D.Sc (AM)
Natural Medicine Practitioner & Researcher

Periodic Health Checkups Boost Cancer Screening Rates

(HealthDay News) -- For people age 50 and older, getting a checkup every year or two may improve the likelihood they'll get the cancer screenings experts recommend, a U.S. study finds.

"Because people go to the doctor anyway when they feel sick or have a medical problem, some authorities have questioned whether preventive, or general, health examinations are worth the extra time and effort," study lead author Joshua Fenton, assistant professor of family and community medicine at the University of California, Davis, said in a prepared statement.

"Our study suggests they are. If people over 50 have checkups every year or two, they're more likely to go ahead and get the cancer screenings they need," Fenton said.

The two-year study, published in the March 26 issue of the journal Archives of Internal Medicine, included over 64,000 patients, ages 52 to 78, who were eligible for breast, colon or prostate cancer screenings. Patients who had a regular checkup during that time were more than three times as likely to get a colon or prostate cancer screening than those who didn't have a checkup. Women who had a checkup were also more likely to be screened for breast cancer.

This difference in screening rates persisted, regardless of how many "illness" visits patients made to doctors during the study. This suggests that doctors may not have time to promote cancer screening when they're assessing a sick patient.

Fenton noted that a recent survey found that 97 percent of primary care doctors said they recommend appropriate cancer screening tests to patients during checkups, but few doctors discuss cancer screening during other types of patient visits.

"The preventive health exam may be an auspicious time to promote cancer screening. These visits may afford primary care physicians the opportunity to discuss and recommend cancer screening when indicated, and physicians' recommendations have been consistently associated with timely cancer screening," Fenton said.

More information
The U.S. National Cancer Institute has more about cancer screening.

Researchers Seek More Women for 'Sister Study' of Breast Cancer

Researchers Seek More Women for 'Sister Study' of Breast Cancer

(HealthDay News) -- So far, more than 33,000 American women have joined the Sister Study, a research effort to uncover the causes of breast cancer.

But the study is still looking for another 17,000 more women to reach its enrollment target of 50,000 women by the end of 2007, according the U.S. National Institute of Environmental Health Sciences (NIEHS).

The study is enrolling women, aged 35 to 74, whose sisters were diagnosed with breast cancer. The women who join the study must never have been diagnosed with breast cancer. The 10-year observational Sister Study was launched in October 2004.

"Many women have heard about the Sister Study, but they haven't signed up yet, and we really need them now," principal investigator Dale Sandler, chief of the epidemiology branch at the NIEHS, said in a prepared statement.

"Doctors know very little about how the environment may affect breast cancer, that is why the Sister Study is so important. We hope women will make that call today," Sandler said.

The Sister Study, which is available in English and Spanish, doesn't require a major time commitment from participants. When they enroll, they answer questions about diet, job, hobbies, and things they've been exposed to throughout their lives. Later, they'll be asked to give small samples of blood. urine, toenail clippings and house dust.

More information
You can learn more by going to the Sister Study Web site, which is also available in Spanish.

Tykerb Approved for Advanced Breast Cancer

(HealthDay News) -- GlaxoSmithKline's Tykerb (lapatinib) has been approved by the U.S. Food and Drug Administration to treat advanced breast cancer when other cancer drugs haven't succeeded, the agency said Tuesday.

Tykerb was sanctioned to be used in combination with Xeloda (capecitabine) for people with advanced, metastatic (spreading) cancer that is positive for a protein called HER2. About 8,000 to 10,000 women die from metastatic HER2-positive breast cancer each year, the FDA said.
Tykerb, among a class of drugs called kinase inhibitors, deprives tumor cells of signals they need to grow. But it differs from other cancer drugs in that it actually enters cells and blocks the function of the HER2 protein, the FDA said.

The drug was tested in a trial involving 400 women with advanced or metastatic breast cancer that was HER2 positive. Common side effects included diarrhea, nausea, vomiting, and rash. A small percentage of participants also had a decrease in heart function that may have been characterized by shortness of breath. This condition generally was reversible, the agency said.

More information
To learn more about breast cancer, visit the U.S. National Cancer Institute.

FDA OKs New Drug for Advanced Breast Cancer

(HealthDay News) -- U.S. regulators approved on Tuesday a new drug that in clinical trials delayed breast cancer progression in women no longer responding to Herceptin, a drug effective against tumors with too much of a protein called HER-2.

When given in combination with chemotherapy, the new drug, Tykerb (lapatinib), did a better job of curtailing cancer growth than did the chemo drug alone.

"Today's approval is a step forward in making new treatments available for patients who have progression of their breast cancer after treatment with some of the most effective breast cancer therapies available," Dr. Steven Galson, director of the U.S. Food and Drug Administration's Center for Drug Evaluation and Research, said in a prepared statement. "New targeted therapies such as Tykerb are helping expand options for patients."

Tykerb, which comes in pill form, is made by GlaxoSmithKline, which funded the clinical trial. The results of the trial were initially announced last June at the American Society of Clinical Oncology annual meeting, in Atlanta.

About 8,000 to 10,000 American women die from metastatic HER2-positive breast cancer each year, the FDA said.

Tykerb, among a class of drugs called kinase inhibitors, deprives tumor cells of signals they need to grow. But it differs from other cancer drugs in that it actually enters cells and blocks the function of the HER2 protein, the agency said.

The drug was tested in a trial involving 400 women with advanced or metastatic breast cancer that was HER2 positive. Common side effects included diarrhea, nausea, vomiting, and rash. A small percentage of participants also had a decrease in heart function that may have been characterized by shortness of breath. This condition generally was reversible, the agency said.
Some 20 percent to 25 percent of breast cancers have abnormally high levels of the HER2/neu receptor and, as a result, are generally more aggressive. Herceptin (trastuzumab) blocks activity of the receptor by binding to the part of the receptor outside the cell. Tykerb, by contrast, binds to a part of the receptor inside the cell.

The clinical trial included a plan for an independent data monitoring committee to analyze data at the halfway point to see if the benefits were larger than anticipated, in which case the committee would recommend the study be closed.

On March 20, 2006, the monitoring committee made a unanimous recommendation to terminate the trial because the results were so encouraging.

Women in the combined therapy group had almost double the time to disease progression as did women receiving Xeloda alone: 36.9 weeks vs. 19.7 weeks.

Responding to the FDA's approval of Tykerb, Dr. Len Lichtenfeld, deputy chief medical officer of the American Cancer Society, said in a prepared statement: "The approval of Tykerb is a significant step forward because it once again demonstrates the promise of targeted therapies, where we take our understanding of how cancer cells work and apply that knowledge to new drug development. We now have a new drug that offers promise and hope to women who have a more aggressive form of breast cancer, where until very recently we had little to offer. And we now have two drugs that are effective in treating this particular form of the disease.

More information
To learn more, visit the U.S. National Cancer Institute.