Megestrol and tamoxifen in patients with advanced endometrial cancer - An Eastern Cooperative Oncology Group study (E4882)

To investigate the effect of adding tamoxifen to megestrol in the hormonal therapy for advanced endometrial cancer, 66 patients were entered in this s tudy. Initially. 41 patients were randomized to either the standard progest in therapy of megestrol or to the combination of megestrol and tamoxifen be tween October 1982 and October 1984. The megestrol arm was terminated becau se of poor accrual and 25 patients were directly assigned to the combinatio n arm. Among the 20 eligible cases on the megestrol arm, the response rate of 20% consisted of 1 complete response and 3 partial responses. The respon se rate on the megestrol plus tamoxifen arm was 19% with 1 (2%) complete re sponse and 7 (17%) partial responses among 42 eligible cases. The median su rvival times were 12.0 months and 8.6 months, respectively. Only mild and m oderate toxicities were observed on megestrol compared with more toxic comp lications observed on the combination of megestrol and tamoxifen, including a life-threatening case of pulmonary embolism. Although we could not carry out a comparative evaluation as intended, we conclude that the combination of megestrol and tamoxifen offers no clinical advantage over megestrol alo ne in the treatment of advanced endometrial carcinoma.