CAP (cyclophosphamide, adriamycin, platinum) vs CMFVP (cyclophosphamide, methotrexate, 5-fluorouracil, vincristine, prednisolone) combination chemotherapy in untreated metastatic breast cancer. A preliminary report of a controlled clinical study.

The prospective controlled phase III clinical trial compared the therapeutic value of the cis-platinum - adriamycin - cyclophosphamide combination (CAP) and that of the combination of cyclophosphamide, methotrexate, 5-fluorouracil, vincristine, and prednisolone (CMFVP) in untreated metastatic breast cancer. Seventy-two patients (greater than 2 cycles) were evaluated: 36 had received CAP and 36, CMFVP. An objective response (CR + PR) to CAP combination chemotherapy was achieved in 75% of patients (27 of 36), with a high rate (42%) of complete remissions. In terms of metastatic site, the response rate appeared to be particularly high in soft tissue and visceral organ (lung, liver) metastases. In the CMFVP group, an objective response was noted in 16 of 36 patients (44%) with 19% complete remissions. Overall therapeutic response and the complete remission rate were better with CAP regimen (statistically significant; P less than 0.01). The duration of remissions was 4-16+ months (M = 12) for CAP and 2-12+ months (M = 8) for CMFVP. Toxic side-effects were more pronounced in the CAP group, particularly myelosuppression, and anemia was prevalent. Side-effects of CMFVP treatment were mild. In 11 CMFVP-resistant cases CAP was administered as second-line treatment, and an objective response was observed in 45% of cases (5 of 11). The preliminary results of this controlled trial show the advantage of the CAP combination in the treatment of metastatic breast cancer.

RCT Entities:   Population Interventions Outcomes