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Title: Success on Tamoxifen Plus Chemotherapy Varies by Age, Menopausal Status: Presented at SABCS

"Success on Tamoxifen Plus Chemotherapy Varies by Age, Menopausal Status: Presented at SABCS"

By Andrew Bowser SAN ANTONIO, TX -- December 13, 2002 -- Chemotherapy plus tamoxifen did not produce a reduction in mortality or relapse any more than did tamoxifen alone in women with breast cancer who were older than 60 years of age or postmenopausal, a new analysis of pivotal trials suggests. The findings, resulting from a new analysis of the National Surgical Adjuvant Breast and Bowel Project trials B-14 and B-20, were presented here December 11th at the 25th Annual San Antonio Breast Cancer Symposium. The analysis included 2,817 women with node-negative, oestrogen receptor (ER)-positive tumours enrolled in one of two tamoxifen studies. Trial B14, first reported in 1989, set the trend for use of this drug in women with node-negative, ER-positive tumours. The second study was B20, which when reported in 1997, showed the advantage of chemotherapy plus tamoxifen vs. tamoxifen alone. At the time, investigators noted that the risk reduction associated with tamoxifen/chemotherapy was 46 percent in patients under the age of 49 and 26 percent in those older than 50 years of age. This reanalysis of tamoxifen trials was prompted in part by results of a recent international trial suggesting that a cyclophosphamide, methotrexate and 5-fluorouracil chemotherapy regimen plus tamoxifen (CMFT) provided no benefit over tamoxifen alone in postmenopausal women. "Our findings suggest that in usual clinical practice, age is likely to be a better discriminant for deciding upon the use of CMFT than is menopausal status," said Bernard Fisher, MD, Lead Researcher and Service Professor at the University of Pittsburgh, Pittsburgh, Pennsylvania, United States. Dr. Fisher and colleagues reanalysed the patients who received CMFT from both trials. Investigators in the trials had reported menopausal status for almost every patient in the studies (98.9 percent). In women aged 49 or younger who received tamoxifen plus chemotherapy, recurrence was reduced by 56 percent vs. placebo, or an absolute 17 percent reduction. The relative and absolute reductions were 56 percent and 13 percent, respectively, in patients 50 to 59 years old. By contrast, women aged 60 or older who received both tamoxifen and chemotherapy had a 25 percent relative and eight percent absolute reduction in recurrence, very similar to what was seen among older women who received tamoxifen only. Similarly, the relative reduction in mortality vs. placebo was 63 percent for patients aged 49 and younger and 56 percent for women aged 50 to 59 who had the combination of therapies. Relative mortality reduction was 25 percent in women aged 60 and older on the combination, which again was similar to what was seen in women who received tamoxifen only. "The outcome of the few patients judged to be perimenopausal was similar to that of patients greater than or equal to 60 years old," Dr. Fisher said.

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