Combination chemotherapy in advanced breast cancer.: a randomized trial comparing a three-vs a five-drug program.

A prospective randomized trial was undertaken to compare the efficacy of a three-drug regimen using cyclophosphamide, methotrexate, and fluorouracil to a five-drug regimen using vincristine sulfate and prednisone in addition to cyclophosphamide, methotrexate, and fluorouracil in advanced breast carcinoma. Seventy-two patients who had received no prior chemotherapy were randomized. Thirty-eight patients received three drugs, and 34 received five-drug therapy. The objective response rates, 34% and 50% respectively, did not differ signficantly (P = .13). As expected, myelosuppression occurred in most patients, and neurotoxicity was much more common in patients receiving vincristine. Three of 12 patients treated with the five-drug regimen after progession of disease while receiving the three-drug regiment showed an objective response to the five-drug regimen.