Paclitaxel in combination with weekly 24-hour infusional 5-fluorouracil plus leucovorin in the second-line treatment of metastatic breast cancer: Results of a phase II study

摘要: Summary Purpose To evaluate the antitumor activity in terms of response rate (RR), time to progression (TTP) and survival paclitaxel combination with weekly 24-hour infusional 5-fluorouracil (5-FU)/leucovorin pretreated metastatic breast cancer (MBC). Patients methods Fifty-four patients bidimensionally measureable disease were included during phase II. Thirty-two had anthracycline resistant disease. Treatment consisted 5-FU (24-hour i.v. infusion) 2.0 g/m2, leucovorin (two-hour infusion prior 5-FU) 500 mg/m2, for six weeks (day 1, 8, 15, 22, 29, 36) (three-hour 175 mg/m2 was administered additionally on days 1 q 50 days. Results We observed complete remissions 4% (2 54), partial 55% (30 stable 37% (20 54) progressive 54). The overall RR 59% (95% CI 48%–72%). 32 (19 32). median duration 12 months 3–22, TTP eight (2–22) 15 (2–28). Neutropenia common, but CTC grade 2 or 3 most patients. Nonhematologic toxicities mostly myalgia, diarrhea, mucosits, nausea vomiting. Conclusions Paclitaxel combined 5-FU/leucovorin is well tolerated second line treatment MBC. High efficacy documented even disease, which warrants further evaluation.