Comparison of toremifene and tamoxifen in post-menopausal patients with advanced breast cancer: a randomized double-blind, the 'nordic' phase III study.

摘要: The study was planned to compare, in a prospective double-blind randomized trial, the efficacy and safety of toremifene (TOR) tamoxifen (TAM) post-menopausal patients with advanced breast cancer who have not had prior systemic therapy for disease. Four hundred fifteen oestrogen receptor (ER)-positive or ER-unknown were randomly assigned receive daily either 60 mg TOR 40 TAM. stratified measurable non-measurable but evaluable groups. They assessed response therapy, time progression (TTP), treatment failure (TTF), duration, overall survival drug toxicity. Two fourteen into 201 TAM treatment. rate (complete + partial) 31.3% 37.3% (P = 0.215). 95% confidence interval (CI) 6% difference -15.1% 3.1%. median TTP 7.3 months 10.2 0.047). CI hazard ratio 0.80 0.64-1.00. A percentage (9.8%) (18.9%) discontinued prematurely 0.011) various reasons. Consequently, TTF 6.3 vs 8.5 did differ significantly 0.271). 0.89 subsequent 0.73-1.09. 33.0 38.7 0.645). 0.94 0.73-1.22. transient may be related an imbalance ER content tumours. When only ER-positive tumours considered (n 238), no between two treatments seen 0.578). associated slightly higher frequency adverse reactions than (44.3 39.3%) discontinuation due these events (3.5% 0.9%). Treatment-emerged moderate dizziness 0.026) cataracts more frequent among patients. In conclusion, (60 day(-1)) (40 are equally effective safe cancer.