WESTPORT, CT (Reuters Health) Nov 29 – In postmenopausal women with early breast cancer, switching from tamoxifen to aminoglutethimide after 3 years of adjuvant treatment appears to improve overall survival significantly, according to new findings published in the November 15th issue of the Journal of Clinical Oncology.
"Should these preliminary results be confirmed…sequencing tamoxifen with an aromatase inhibitor could become a preferable alternative to tamoxifen alone in early breast cancer patients," Dr. Francesco Boccardo, of the University and National Cancer Research Institute, Genoa, Italy, and other investigators for the Italian Breast Cancer Cooperative Group suggest in the report.
The investigators randomized 380 postmenopausal breast cancer patients who had been using adjuvant tamoxifen for 3 years. For the next 2 years patients either continued on tamoxifen or used low-dose aminoglutethimide (250 mg/day).
Dr. Boccardo and others observed no "major advantages" in terms of event-free survival in the aminoglutethimide group versus patients who continued to use tamoxifen. However, when they looked at overall survival, a highly significant difference emerged, favoring patients who switched to aminoglutethimide (p = 0.005). Moreover, in terms of breast cancer-specific survival, there was a trend in favor of the aminoglutethimide group (p = 0.06).
Serious adverse events occurred less often in the aminoglutethimide group, despite a higher rate of drug-related complaints and treatment discontinuation in this group than in the tamoxifen group.
The authors warn that their findings are preliminary. "The size of this trial and the number of events that have occurred so far are relatively small," they point out. "Therefore, we cannot rule out that the results observed might be because of chance or confounding factors."
Nevertheless, Dr. Boccardo's group suggests that the sequential tamoxifen-aminoglutethimide protocol could become the standard first-line therapy for early breast cancer patients if the results are confirmed in larger, ongoing trials of newer aromatase inhibitors.
J Clin Oncol 2001;19:4209-4215.
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