Combined cytotoxic and endocrine therapy in postmenopausal patients with advanced breast cancer. A randomized EORTC study of CMF vs CMF + tamoxifen.

摘要: Two hundred and sixty-three patients with advanced measurable breast cancer were randomized to receive cyclophosphamide, methotrexate 5-fluorouracil (CMF) or CMF + tamoxifen (T). Each cycle of (C, 100 mg/m2 p.o. days 1–14, M, 40 i.v. 1 8, F, 600 8) was repeated every 4 weeks. Tamoxifen, 20 mg twice daily, given continuously. The treatment results as assessed by external reviewing follows in the T groups, respectively: PD 24 10%, NC 27 15%, PR 29 44%, CR 31%. difference between response (CR PR) rates is highly significant (P = 0.0001). Derived from life-table analysis, median duration remission 12 months CMF-treated group 18 treated CMP 0.04). Median survival 19 months, respectively 0.12), but responders CMF+T significantly superior (32 vs 21 P 0.03). addition benefit all subgroups only reached statistical significance dominant site disease viscera, a Karnofsky index more than 60 years age. amount identical two groups trend for decrease dose increasing No relation rate observed. In conclusion, improves therapeutic although superiority combined statistically some subsets patients.