A phase II trial of weekly paclitaxel and high-dose 5-fluorouracil plus leucovorin in patients with chemotherapy-pretreated metastatic breast cancer.

BACKGROUND Weekly paclitaxel and infusional high-dose 5-fluorouracil/leucovorin (HDFL) are both effective regimens for metastatic breast cancer (MBC) patients. PATIENTS AND METHODS A study was designed using weekly paclitaxel 90 mg/m(2) 1-hour infusion followed by 2,000 mg/m(2) 5-fluorouracil plus 300 mg/m(2) leucovorin 24-hour infusion on days 1, 8 and 15, repeated every 28 days, in patients who had previously received a > or =1 regimen for MBC. The dose of paclitaxel was adjusted in each cycle according to toxicity. RESULTS A total of 182 cycles were given to 28 patients. The doses of paclitaxel needed to be reduced only in 22 (12%) cycles. Forty-five cycles were skipped or delayed more than 7 days, mostly due to neutropenia, infection, or neurotoxicity. Twenty-five patients were evaluable for response. Four had complete response, 13 partial response, seven stable disease, and two progressive disease. The response rate was 60.7% (95% CI: 42.6-78.8). Median survival was 18.1 months (95% CI: 11.4-24.9), and progression-free survival seven months. CONCLUSION Weekly paclitaxel plus infusional HDFL is an active and well tolerated regimen for pretreated MBC patients.