Clinical controlled trial in advanced breast cancer: CMFV (cyclophosphamide, methotrexate, fluorouracil, vincristine) verus CD (carminomycin, dibromodulcitol).

A controlled study with two independent cytostatic combinations in advanced breast cancer was performed in total 236 patients. Results of the treatment in 218 evaluable patients are reported. The first combination included cyclophosphamide, methotrexate, 5-fluorouracil, and vincristine (CMFV, 108 patients), the second one carminomycin and dibromodulcitol (CD, 110 patients), both treatments having been administered intermittently. Those patients who became resistant to the first applied schedule or those after five CD cycles, were crossed over to the alternative schedule. Patients were perspectively stratified according to dominant sites of metastases and randomized then to the treatment schedule. Overall response (CR + PR + MR) was achieved in CMFV combination in 35/108 patients (32%), conventional response (CR + PR) in 31/108 patients (29%), complete response (CRP) in 7/108 patients (7%). In CD combination the corresponding values were 34/110 (31%), 27/110 (25%), 1/100 (1%). Response (CR + PR) in patients crossed over from CMFV to CD was seen in 2/37 patients (5%), and from CD to CMFV in 4/36 patients (11%). Median duration of response observed in the CMFV combination was 5.5 months (range 1-12 + months), in the CD combination 4.5 months (range 1-15 months). Toxic reactions were reversible, grade 3 and 4 cardiotoxicity in the CD combination in 4% of patients in the primary treatment and in 14% in patients when crossed over from the primary treatment and in 14% in patients when crossed over from the primary CMFV regimen.