Doxorubicin versus methotrexate both combined with cyclophosphamide, 5-fluorouracil and tamoxifen in postmenopausal patients with advanced breast cancer—a randomised study with more than 10 years follow-up from the danish breast cancer cooperative group

摘要: To evaluate the substitution of methotrexate with doxorubicin (Dox) in CMF-(cyclophosphamide, methotrexate, 5-fluorouracil) containing regimen for advanced breast cancer, 415 postmenopausal patients below age 66 years, naive to chemotherapy, were accrued from 1980 1984 and followed-up until 1995. They received tamoxifen 30 mg daily orally by randomisation either 400 mg/m2, cyclophosphamide, 25 mg/m2 500 5-fluorouracil (CAF) or 40 instead Dox (CMF) intravenously (i.v.) days 1 + 8 repeated every 4 weeks. was substituted at a cumulative dose 550 mg/m2. Among 341 eligible response rate median time progression significantly favour CAF: 53% CAF versus 36% CMF (P = 0.002) 11.8 months 6.5 0.001). Median duration 19.5 18.0 months, survival 20.8 17.4 (non-significant). The two regimens equimyelotoxic. There no treatment-related fatalities but patient congestive heart failure on reported. Nausea/vomiting, stomatitis infections modest both groups, whilst alopecia more common CAF. Regression analysis showed that long recurrence free interval, good performance status, visceral involvement related long-term survival, treatment not. It is concluded chemotherapy-naive cancer Dox-containing are superior remain first choice especially metastases, newer drugs combinations have been proven be superior.