Prostate Cancer Treatment Risk

An increasingly popular prostate cancer treatment also makes bones brittle and may be responsible for over 3,000 fractures each year in the United States, researchers reported recently.

The treatment calls for blocking the effects of the male hormone testosterone, either with drugs or by castration. Until now, doctors have regarded the treatment as relatively harmless, Vahakn Shahinian, chief author of the new research, told Reuters. He said that given the new findings, doctors and patients should be aware of the risks of the therapy, which seems to slow the growth of prostate tumors, but may not always help patients live longer.

Heart Risk in Another Drug

A new study has found that Aleve, a popular over-the-counter painkiller made by Bayer, could increase heart problems, and US government officials are warning patients not to exceed the recommended dose of two 200-milligram pills a day or to continue therapy for more than 10 days with-out consulting a doctor.

Aleve is the fourth big-selling pain medicine in recent months to be suspected of hurting the heart, and federal officials said that similar drugs, like Advil, might also increase heart risks. Patients taking a prescription form of Aleve known as Naprosyn or naprogen should consult their doctors.

The study, sponsored by the National Institutes of Health, was intended to measure whether Aleve and Celebrex; which is made by Pfizer, might prevent Alzheimer's disease. In the study, nearly 2,500 patients were given one of the two drugs or a placebo and were followed for three years. Those taking Aleve had a 50 per cent greater rate of heart problems - including heart attacks and stroke - than those given a placebo. The Celebrex patients saw no increase in heart problems.

Last month, it was announced that a different national study had found that those given high doses of Celebrex had a 240 per cent increase in heart problems, some of them fatal. Merck executives withdrew their painkiller Vioxx after a study found that it increased the risk of heart attack and stroke by more than 100 per cent.

Also, Pfizer announced recently that a study of Bextra found that it increased the risk of heart attacks in those who had had cardiac surgery.

US officials said that the entire class of painkillers known as nonsteroidal anti-inflammatories - including Celebrex, Advil and Mobic - could cause worrisome heart symptoms. Sales of Celebrex, along with those of other anti-inflammatories, like Advil and Mobic, are expected to fall as a result.

FDA was studying the results of this latest study and will be assessing what regulatory actions are appropriate over the next day or two.

The latest results could prove beneficial to Pfizer, which has been arguing that last week's finding about Celebrex should be placed in the context that similar pills may be just as harmful to the heart and that other studies of Celebrex have shown no such problems. Indeed, if there is one message from these studies, it is that nothing is certain.

The results surprised many observers because other studies suggested that naproxen may actually protect the heart. Some said the latest results suggested that many pain pills were far too popular in the United States.

Many critics of the drug industry say that the manufacturers have used widespread advertising to sell medicines to more patients than need them. Drug manufacturers make more than half of their sales and the majority of their profits in the United States, and drug side effects are one of the leading causes of deaths in the United States, critics say. The one drug that is known to protect the heart is aspirin, All other painkillers are now under suspicion.

Those making the announcement recently cautioned that the results were preliminary. Researchers decided to stop the trial because news of problems with Celebrex had led many of the subjects to threaten to drop out of the study. Researchers had long known that those given naproxen in the study had a somewhat increased risk of heart problems, but that increased risk is not what led them to stop the study.

A safety committee overseeing the trial met as recently as December 10 and decided that the results were not worrisome enough to stop the trial. Only when last month widely publicized test of Celebrex found that that drug could more than triple the risk of heart disease did the researchers decide to end the study and issue their warnings about Aleve, even though the increase in heart risks may not prove to be statistically significant, once they are subjected to further analysis. A Bayer spokesman had no comment to offer.

Health professionals and experts say, making a decision to suspend a trial was far different and far easier than making regulatory decisions about drugs. In the case of the Alzheimer's trial, patients were taking the medicines simply in hopes of preventing a disease, not because the medicines were providing a needed benefit. It is very different advising patients who need such medicines to soothe their pain, Zerhouni said.

Letrozole reduces the risk of rost-surgery recurrence of early breast cancer when compared with Tamoxifen, study shows

In postmenopausal women with early breast cancer, letrozole offers better post-surgery protection against breast cancer recurrence than does tamoxifen, the current standard of care, according to data presented on Wednesday at the Primary Therapy of Early Breast Cancer 9th International Conference in St. Gallen, Switzerland. The data from the Breast International Group (BIG) 1-98 Trial showed a significant difference in disease-free survival (DFS) in favor of letrozole.

"The results of BIG 1-98 are of great importance for the majority patients with breast cancer. Letrozole reduced the risk of cancer recurrence by 19 per cent beyond the risk reduction achieved by tamoxifen. We now have an additional tool to improve the outcome for postmenopausal women with hormone sensitive breast cancer. Together with optimal surgery, followed by chemotherapy and radiotherapy if needed, incorporation of letrozole in the treatment plan is a step forward in the patients' way of remaining disease from cancer. Further investigations and longer follow-up are necessary to optimize the use of letrozole in order establish longterm safety and tolerability of the drug and to further improve its treatment benefits," says PD Dr. Thurlimann, BIG 1-98 Trial study chair.

BIG 1-98 is the first clinical trial ever designed to incorporate both a head-to-head comparison of letrozole with tamoxifen and a sequencing of both agents, during the first five years following breast cancer surgery, to determine the most effective approach to minimizing the risk of breast cancer recurrence.

The Study Compares:

Data from the study are expected to answer important questions regarding the optimal sequencing of aromatase inhibitor therapy in postmenopausal women with endocrineresponsive early breast cancer.

Methods and Results

BIG 1-98 is a multinational Phase III double-blind, randomised multicenter trial that is being conducted in 27 countries and involves more than 8000 postmenopausal women with early breast cancer who have hormone receptor-positive tumors.

A primary goal of the study was to determine if letrozole could reduce the risk of a disease-free survival event (breast cancer relapse, occurrence of a second (non-breast) malignancy or death without recurrence) compared with tamoxifen. At a median follow-up of 26 months the study shows that, compared with tamoxifen, letrozole reduced the risk of such events by 19 per cent. Among the 4003 patients in the letrozole group, 84.0 per cent remained alive and disease-free at five years compared with 81.4 per cent of the 4007 patients in the tamoxifen group.

There was also a difference in side effects between letrozole and tamoxifen.

Heart attacks and strokes slightly more often, though these events were very rare with both treatments. Early breast cancer is defined as cancer that is localized to breast tissue and/or nearby lymph nodes. Worldwide, about 800,000 women are diagnosed with early breast cancer every year.

Primary therapy for early breast cancer usually involves surgery to remove the tumor and surrounding tissue. Standard post-surgery therapy (early adjuvant) typically includes radiation and/or chemotherapy, followed by treatment with five years of tamoxifen, previously the "gold standard of care" for postmenopausal women.

BIG 1-98 is being conducted under the umbrella of the Breast International Group, coordinated and managed by the International Breast Cancer Study Group (IBCSG). Novartis, the producer and distributer of letrozole (Femara(R)) gave financial support. The IBCSG is an active member of the BIG organization.

About The International Breast Cancer Study Group

The International Breast Cancer Study Group (IBCSG) is a non-profit organisation founded as the 'Ludwig Breast Cancer Study Group' in 1977, which has always been dedicated to innovative clinical research designed to improve the outcome of women with breast cancer. The IBCSG is headquartered in Bern as a foundation under Swiss law. The Statistical and Data Management Centers are in the United States (Boston, MA and Amherst, NY), and the central pathology review offices are in Milan, Italy and Glasgow, Scotland.

About the Breast International Group

The Breast International Group is an international non-profit organization dedicated to serve as a network for large breast cancer trials among its members. The participants are well established clinical research and cooperative groups based in Europe, Australia, New Zealand, South Africa, and Canada, with affiliated centers around the world.

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