Tamoxifen in the treatment of advanced or recurrent endometrial carcinoma:A gynecologic oncology group study

Purpose: In two large Gynecologic Oncology Group studies of patients with a dvanced or recurrent endometrial carcinoma and no previous systemic therapy , progestins have demonstrated activity against advanced or recurrent endom etrial carcinoma with response rates between 15% and 25%. Tamoxifen has bee n reported as variously active or inactive with or without previous systemi c therapy. The purpose of this study was to determine whether tamoxifen exh ibits enough activity in patients with advanced or recurrent endometrial ca rcinoma, who have not received systemic therapy, to warrant a phase III tri al. Patients and Methods: Sixty-eight eligible patients with advanced or recurr ent endometrial carcinoma received oral tamoxifen 20 mg bid until toxicity was unacceptable or disease progressed. Results: Three complete (4%) and four partial (6%) responses were observed for an overall response rate of 10% (90% confidence interval [CI], 5.7% to 17.9%). Patients with tumors that were more anaplastic tended to respond le ss frequently. The median progression-free survival for all 68 eligible pat ients was 1.9 months (90% CI, 1.7 to 3.2 months). The median survival wets 8.8 months (90% CI, 7.0 to 10.1 months). Conclusion: Tamoxifen demonstrated modest activity at best against endometr ial carcinoma and does not warrant further investigation as a single agent for this disease. Ongoing trials will assess the sequential use of tamoxife n and progestational agents. J Clin Oncol 19:364-367. (C) 2001 by American Society of Clinical Oncology.