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Summaries of Newsworthy Clinical Trial Results

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    Posted: 05/01/2000    Updated: 01/19/2005
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Early Breast Cancer Patients Benefit from Shortened Chemotherapy

Women with one type of early breast cancer get the same benefit from three months of one chemotherapy as they do from six months of another drug combination, according to a large study presented at the 2000 American Society for Clinical Oncology annual meeting. (Updated information below.)

The results mean that breast cancer patients who do not benefit from the drug tamoxifen - which includes about half of all early cases - can halve the duration of their drug therapy without diminishing the chances for long-term survival.

The study compared the chemotherapy combination AC (adriamycin and cyclophosphamide) to the more widely used CMF (cyclophosphamide, methotrexate, and flurouracil) in 2,000 women whose cancer had not spread to their lymph nodes and who had tumors classified as estrogen receptor negative. Half received four cycles of AC over three months; the other half received six cycles of CMF over six months. Cancer-free survival after five years was 82 percent in both groups and overall survival was 89 percent in both.

"There has been a swing toward using the AC regimen, and these findings should accelerate that trend," said Bernard Fisher, M.D., the lead researcher on the study conducted by the National Surgical Adjuvant Breast and Bowel Project in Pittsburgh.

Dr. Lori GoldsteinLori Goldstein, M.D., of Fox Chase Cancer Center in Philadelphia, went a step further by saying, "This is one of the studies that will have a direct and immediate impact on patients being treated today."

That impact includes three fewer months of side effects that can include fatigue, nausea, and generally diminished quality of life.

Begun in 1991, the study originally sought to measure tamoxifen's worth in women who had estrogen receptor negative breast tumors. To that end, half of each of the two groups of women received tamoxifen in addition to their AC or CMF regimens. In the intervening decade, though, lab researchers discovered that tamoxifen acts directly on estrogen receptors to shut down tumor growth. It was no surprise, Fisher said, when tamoxifen offered no extra benefit to either group in the study.

He also took the opportunity to summarize progress against the disease. "I think we have made, in the last five or ten years, particularly in lymph node negative patients, greater strides than we have in all the years before. Early detection has made it possible for, not only for people to do better, but for therapeutic agents to work better."

(Updated information: The full report was subsequently published in the Feb. 15, 2001, issue of the Journal of Clinical Oncology [see the journal abstract]. An updated analysis confirming the findings was also published in the Dec. 15, 2004, issue of the Journal of the National Cancer Institute [see the journal abstract].)

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