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December 11, 2007 NEW YORK (Reuters Health) - Women with breast cancer who complete 5 years of tamoxifen therapy derive significant benefit from an additional 3 years of treatment with the aromatase inhibitor anastrozole, results of the Austrian Breast and Colorectal Study suggest. Study subjects were women with hormone receptor-positive postmenopausal breast cancer who were disease free following primary surgery and 5 years of adjuvant tamoxifen therapy. They were randomly assigned to 3 years of anastrozole (n = 387) or no further treatment (n = 469). After median follow-up of more than 5 years, anastrozole treatment was associated with a statistically significant 38% reduced risk of locoregional recurrence, contralateral breast cancer, or distant metastasis, compared with no further treatment, Dr. Raimund Jakesz, from Vienna Medical University, and colleagues report. According to their paper in the December 11 issue of the Journal of the National Cancer Institute, there was no significant between-group difference in overall survival. Three years of anastrozole following 5 years of tamoxifen was generally well tolerated and "no unexpected adverse events were reported," Dr. Jakesz and colleagues note. They suggest that the "more manageable side effect profile of anastrozole compared with tamoxifen may allow the duration of adjuvant treatment to extend beyond the 5-year period recommended for tamoxifen." In an accompanying editorial, Dr. Tatiana Powell and Dr. Vered Stearns of Johns Hopkins University School of Medicine say these results "provide further support for extending the total duration of adjuvant therapy with sequential tamoxifen and an aromatase inhibitor to 8 years." "However, whether such a course of extended adjuvant therapy is superior to either aromatase inhibitor monotherapy or shorter courses of sequential therapy is presently unknown," they add. The Boston-based editorialists also point out that, while the safety profile of extended adjuvant therapy with an aromatase inhibitor "appears to be generally acceptable," with increasing clinical use of these agents "it has become clear that clinical trials of aromatase inhibitors in the adjuvant setting may have underestimated the prevalence and severity of musculoskeletal symptoms that are associated with aromatase inhibitors." Recent observational studies, Drs. Tatiana Powell and Vered Stearns note, have shown that nearly half of patients taking adjuvant aromatase inhibitors experienced symptoms of joint pain and stiffness. One quarter of these symptoms were described as severe, and led to drug discontinuation within the first year by up to 13% of women. Copyright 2008 Reuters. Click for Restrictions.
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