A phase II trial of anastrozole in advanced recurrent or persistent endometrial carcinoma: A gynecologic oncology group study

Background. Some endometrial cancers are hormonally dependent, A principal source of circulating estrogen is conversion of adrenal androstenedione by aromatase, Anastrozole (Arimidex) is an oral nonsteroidal aromatase inhibit or which is active in recurrent breast cancer. This Phase II study was unde rtaken to evaluate anastrozole in recurrent endometrial carcinoma. Methods. Patients with advanced or recurrent endometrial cancer not curable with either surgery or radiation therapy and with measurable disease, a GO G (Zubrod) performance status of less than or equal to 2, no more than one prior hormonal therapy regimen, and no prior chemotherapy were eligible. An astrozole was administered at a dose of 1 mg/day orally for at least 28 day s. Results. Twenty-three patients were entered on this trial, On central patho logy review, 9 of them had grade 2 and 14 had grade 3 tumors. One to 24 cou rses (median: 1) of therapy were administered. Two partial responses were n oted (9%; 90% confidence interval 3 to 23%), Two additional patients had sh ort-term stable disease. With the exception of 1 case of venous thrombosis, the toxicity profile was mild. Median durations of progression-flee surviv al and overall survival are 1 and 6 months, respectively. Conclusions. Anastrozole has minimal activity in an unselected population o f patients with recurrent endometrial cancer. (C) 2000 Academic Press.