Phase II study of vinorelbine with protracted fluorouracil infusion as a second- or third-line approach for advanced breast cancer patients previously treated with anthracyclines

Purpose: to evaluate the feasibility and activity of vinorelbine in associa tion with protracted infusional fluorouracil in patients with advanced brea st cancer who were previously treated with anthracycline-containing regimen s. Patients and Methods: Eighty-three consecutive patients were entered onto t he study. Forty-three patients experienced treatment failure or relapse aft er anthracycline-based, first-line chemotherapy for advanced disease and 29 experienced treatment failure or relapse after first- and second-line appr oaches; 11 patients experienced progressive disease within 6 months of comp letion of adjuvant anthracycline therapy. Sites of involvement were as foll ows: liver involvement, 42 patients (50.6%); lung 24 (28.9%); bone, 49 (59. 0%); and skin/lymph nodes, 21 (25.3%). Treatment consisted of vinorelbine 3 0 mg/m(2) administered on days 1 and 15 every 28 days and fluorouracil 200 mg/m(2)/d given continuously over a 24-hour period. Results: Toxicity was recorded for 441 cycles. The scheme wets well tolerat ed: grade 1/2 nausea/vomiting occurred in 13 patients(15.6%), grade 1/2 dia rrhea in nine (10.8%), and grade 2/3 stomatitis in six (7.2%). Three patien ts (3.6%) experienced grade 3/4 leukopenia and four (4.8%) experienced grad e 2/3 anemia. Grade 2/3 neurologic toxicity was observed in three cases (3. 6%), and grade 2/3 hand-foot syndrome war observed in three (3.6%). The med ian relative dose-intensity was 92% and 100% for vinorelbine and fluorourac il, respectively. Six patients (7.2%) attained a complete clinical response and 45 (54.2%) attained a partial response, for an overall response rate o f 61.4% (95% confidence interval, 50.9% to 71.9%). Twenty-one patients (25. 3%) obtained disease stabilization, and 11 (13.3%) experienced disease prog ression. Median time to progression in responding patients was 15 months; m edian overall survival of the entire population wets 22 months. Conclusion: Vinorelbine associated with protracted infusional fluorouracil is an active and manageable scheme in advanced breast cancer patients previ ously treated with anthracyclines. The response obtained is durable. J Clin Oncol 18:3370-3377, (C) 2000 by American Society of Clinical Oncology.