RANDOMIZED COMPARISON OF TAMOXIFEN AND 2 SEPARATE DOSES OF TOREMIFENEIN POSTMENOPAUSAL PATIENTS WITH METASTATIC BREAST-CANCER

Purpose: To perform a randomized three-arm comparison tamoxifen (TAM; 20 mg/d) and two separate doses of toremifene (TOR; 60 mg/d [TOR60] an d 200 mg/d [TOR200]) in postmenopausal patients with hormone receptor- positive or -unknown metastatic breast cancer. Materials and Methods: Six hundred forty-eight patients with hormone receptor-positive or -un known metastatic breast cancer were randomly assigned to receive TAM ( n = 215), TOR60 (n = 221), or TOR200 (n = 212). Results: The combined response rates (by intent to treat) were as follows: TAM, 44%; TOR60, 50%; and TOR200, 48%. Complete and partial response rates were as foll ows: TAM, 19%; TOR60, 21%, and TOR200, 23% (not statistically differen t). Median times to progression and overall survival were not signific antly different. Adverse events (lethal, serious but nonlethal, and im portant but non-life-threatening) were similar in all three arms, exce pt that patients in the TOR200 arm had a statistically significantly i ncreased rate of nausea (37% v 26% and 26% for TOR200, TAM, and TOR60, respectively; P = .027). Quality-of-life assessments were not differe nt among the three arms. Conclusion: The activity, toxicity, and side effects of TOR in postmenopausal women with hormone receptor-positive or -unknown metastatic breast cancer are similar if not equivalent to those of TAM. We detected no clear evidence of ct dose-response effect for TOR. TOR60 is on effective and safe agent for the treatment of po stmenopausal women with hormone receptor-positive metastatic breast ca ncer and can be considered an alternative to TAM as first-line treatme nt for such patients. (C) 1995 by American Society of Clinical Oncolog y