Phase III randomized trial of toremifene vs tamoxifen in hormonodependant advanced breast cancer

Purpose. Efficacy and safety of toremifene (TOR) 60 mgs/dayly/o.r. was comp ared with tamoxifen (TAM) 40 mgs/dayly/o.r. in a group of postmenopausal wo men with advanced breast cancer, without previous systemic therapy for adva nced breast cancer. Material and methods. The study was a prospective double-blind randomized t rial. All treated patients presented with positive estrogen receptors. Main end points were response rates, toxicity profile analysis, time to progres sion and survival. WHO and ECOG criteria were employed for response evaluat ion while toxicity was assesed according to WHO guidelines. Curves were con structed by means of Kaplan-Meier methodology and were compared by means of log-rank test. Results. From January 1996 to January 1999 a total of 217 patients were inc luded in the study (106 in the TOR branch and 111 in the TAM arm). Both gro ups of patients were homogeneous regarding the main prognostic factors. A r esponse rate of 64% (68/106) was observed in the TOR group as compared with a 52% (58/111) in the TAM group. Median times to progression and overall s urvival were not significantly different. A lower incidence of undesirable effects was apreciated in the TOR arm. Conclusions. Our data suggest that TOR is an efficient and well-tolerated a gent for the therapy of postmenopausal women with hormonal positive recepto rs advanced breast cancer, and must be considered an alternative to TAM as first line therapy for ER+ advanced breast cancer patients and as well as a n adjuvant treatment.