A phase III clinical trial comparing the combination cyclophosphamide, adriamycin, cisplatin with cyclophosphamide, 5-fluorouracil, prednisone in patients with advanced breast cancer.
The efficacy was assessed of a regimen consisting of 4 cycles of cyclophosphamide, adriamycin, cisplatin (CAP) followed by maintenance with cyclophosphamide, 5-fluorouracil, prednisone (CFP) compared with CFP alone in a randomized trial of 86 patients with advanced breast cancer. The objective regression rates were 46% (CFP) and 49% (CAP with CFP) which included complete regression rates of 7% (CFP) and 4% (CAP with CFP). The median time to progression was 9 mo. for CFP and 6 mo. for CAP with CFP. Median survival in the CFP group was 18 mo. vs. 11 mo. in the CAP recipients. Due to the therapeutic trend in favor of patients receiving CFP, the study was terminated before achieving the initially projected accrual. Over a 2-fold excess of substantial nausea and vomiting among patients receiving the Pt-based regimen was observed. The CAP followed by the CFP regimen is a more toxic program that offers no clinically meansingful improvement over CFP to patients with advanced breast cancer.