Treatment with a nonanthracycline regimen in advanced breast cancer - Vinorelbine, cyclophosphamide, and 5-fluorouracil with folinic acid

The efficacy of combination therapy with vinorelbine, cyclophosphamide, and 5-fluorouracil was assessed in women who had received no prior therapy for locally advanced or metastatic breast cancer. Sixty patients with metastat ic breast cancer who had finished any adjuvant therapy at least 6 months pr eviously and who had not received treatment for advanced disease were enter ed onto the study. The schedule consisted of vinorelbine (Navelbine, Pierre Fabre Medicament) 25 mg/m(2) on days 1 and 8, cyclophosphamide 500 mg/m(2) on day I, and 5-fluorouracil 500 mg/m(2) followed by folinic acid 200 mg/m (2) on days 1 and 8. Treatment was repeated every 21 days up to a maximum o f 8 cycles. Objective responses were observed in 27 of 60 patients (45%; Cl -95 32.4-57.6) including 4 complete responses (6.7%; Cl-95 0-13) and 23 par tial responses (38.3%; Cl-95 22.5-54.1), The responses were achieved in bot h visceral and nonvisceral sites and at the same rate for patients with mul tiple sites of disease. Neutropenia was dose Limiting, with 40% of patients affected at grade 3 or 4, while other hematologic and nonhematologic toxic ity was very mild. This schedule achieves good levels of response without t he use of an anthracycline, so it is suitable either for patients who have been extensively exposed to anthracyclines during adjuvant therapy or for t hose who have other contraindications to their use.