The prospective controlled Phase III clinical trial tested the therapeutic value of the
cis-platinum-
adriamycin-
cyclophosphamide combination (CAP), compared with the combination including
cyclophosphamide,
methotrexate,
5-fluorouracil,
vincristine and
prednisolone (
CMFVP), in untreated metastatic
breast cancer. One hundred and twenty-three patients (greater than 2 cycles) were evaluated: 61 on the CAP, and 62 on the
CMFVP schedule. An objective response (CR + PR) to
CAP combination chemotherapy was achieved in 72% of patients (43/61), with a high rate (36%) 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 26 of 62 patients (42%), with 16% complete remissions. The difference in overall therapeutic response - and in the complete remission rate as well - was statistically significant to the advantage of the CAP regimen (P less than 0.01). The duration of remissions was 6-28 + months (means = 14) for the CAP, and 4-15 + months (mean = 9) for the
CMFVP schedule. Toxic side effects were more pronounced in the CAP group, particularly myelosuppression, with
anemia prevailing. Side effects of
CMFVP treatment were moderate. In 39
CMFVP previously treated cases, CAP was administered as second-line treatment, and an objective response was observed in 51% of cases (20/39). Results of this controlled trial showed the advantage of the
CAP combination chemotherapy in the treatment of metastatic
breast cancer.