RANDOMIZED STUDY COMPARING CHEMOTHERAPY WITH AND WITHOUT ESTROGEN PRIMING IN ADVANCED BREAST-CANCER

A randomized trial was performed to determine if combination chemother apy (CT) with estrogen (E) priming (E+ study arm) was superior to CT a lone (E- study arm) in patients with advanced breast cancer. CT for bo th arms included adriamycin + vincristine (AV) starting on day 7 alter nating with cytoxan + methotrexate + fluorouracil (CMF) starting on da y 28, the entire cycle repeated every 6 weeks. Estrogen priming consis ting of 2 mg estradiol + 1 mg estriol (E+ arm) was given orally twice daily beginning on day 1 and continuously through CT until disease pro gression or unacceptable toxicity. Performance status (KPS) for all pa tients (n=19, E+ arm; n=22, E- arm) ranged between 70-100%. Mean age ( 53 y, E+ arm; 56 y, E- arm), menopausal and estrogen receptor status a nd treatment duration (approximately 38 weeks) were similar for both g roups. Estrogen priming did not alter or enhance CT toxicity. Objectiv e responses (CR,PR) were noted in 79% on the E+ arm (CR=11%, PR=68%) a nd in 73% on the E- arm (CR=9%, PR=64%). Thus, estrogen priming in thi s cohort of patients with advanced breast cancer did not appear to add to the toxicity or palliative benefit of CT.