PACLITAXEL AND VINORELBINE IN ANTHRACYCLINE-PRETREATED BREAST-CANCER - A PHASE-II STUDY

Background: Paclitaxel and vinorelbine are active in advanced breast c ancer pretreated with anthracyclines We therefore conducted a phase II study to define the toxicity and activity of paclitaxel and vinorelbi ne administered in combination. Patients and methods: Our patient popu lation consisted of 37 patients with metastatic breast cancer, 35 of w hom had received prior chemotherapy including anthracyclines. The trea tment regimen included vinorelbine (25 mg/m(2) i.v.) followed by pacli taxel (135 mg/m(2) i.v. as a 3-hour infusion) on day 1; vinorelbine wa s repeated on day 8 in the first 14 patients and on day 3 in the remai ning 23 patients. Results: Because of grade 4 neutropenia, the second dose of vinorelbine was reduced or omitted in 88% of the courses on th e days 1 and 8 schedule and in 48% of the courses on the days 1 and 3 schedule. As a consequence the administered dose intensity of vinorelb ine was significantly higher on the days 1 and 3 schedule (13 mg/m(2)/ wk versus 8.3 mg/m(2)/ wk, P = 0.005). The overall response rate was 3 8% (95% CI: 22-55); four responses have been observed in the ten patie nts with absolute anthracycline resistance. The median duration of res ponse was 6.5 months. Conclusions: The combination of paclitaxel and v inorelbine is a feasible and active salvage regimen in advanced breast cancer patients pretreated with anthracyclines.