RANDOMIZED PHASE-II TRIAL OF INFUSIONAL FLUOROURACIL, EPIRUBICIN, ANDCYCLOPHOSPHAMIDE VERSUS INFUSIONAL FLUOROURACIL, EPIRUBICIN, AND CISPLATIN IN PATIENTS WITH ADVANCED BREAST-CANCER

Purpose: We previously developed an inpatient regimen that consisted o f infusional fluorouracil (5-FU), epirubicin, and cisplatin (ECisF), w ith a response rate of 86% in advanced breast cancer. The current phas e II 2:1 randomised study investigated whether cyclophosphamide can be substituted for cisplatin (ECycloF) to reduce toxicity and allow the regimen to be administered on an outpatient basis without loss of effi cacy. Patients and Methods: Ninety-six women (median age, 49 years; ra nge, 28 to 73) with breast cancer (59 metastatic, 37 locally advanced) received continuous infusional 5-FU (200 mg/m(2)/d via Hickman line) and six cycles of epirubicin (60 mg/m(2) every 21 days) with either cy clophosphamide 600 mg/m(2) every 21 days (38 metastatic, 24 locally ad vanced) or cisplatin 60 mg/m(2) every 21 days (21 metastatic, 13 local ly advanced). There were no significant differences in patient charact eristics between these groups. Results: ECycloF was better tolerated t han ECisF in terms of lethargy (P = .005), stomatitis (P = .008), plan tar palmar erythema (P = .02), constipation (P < .001), thrombosis (P = .0014), and nausea and vomiting (P = .05). Although there was a tren d toward more anemia and leukopenia with ECisF (P = .1), there was no significant difference in the rates of infection. Efficacy was compara ble in terms of overall response (69% v 68%), complete response (CR; 1 3% v 15%), and median progression-free survival (9 v 8 months). Conclu sion: ECycloF is an outpatient regimen with a lower incidence of sever e nonhematologic toxicity than inpatient ECisF; it has comparable effi cacy and is considerably more economical. (C) 1998 by American Society of Clinical Oncology.