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Annals of Oncology 7:857-860, 1996
© 1996 European Society for Medical Oncology

brief-report

Paclitaxel and vinorelbine in anthracycline-pretreated breast cancer: A phase II study

A. Michelotti, A. Gennari, B. Salvadori, A. Tognoni, C. Tibaldi, E. Baldini and P. F. Conte

Division of Medical Oncology, St. Chiara Hospital Pisa, Italy

Correspondence to: Pier Franco Conte, MD Division of Medical Oncology Santa Chiara Hospital Via Rorna 67 56100 Pisa, Italy

BACKGROUND:: Paclitaxel and vinorelbine are active in advanced breast cancer pretreated with anthracyclines We therefore conducted a phase II study to define the toxicity and activity of paclitaxel and vinorelbine administered in combination.

PATIENTS AND METHODS:: Our patient population consisted of 37 patients with metastatic breast cancer, 35 of whom had received prior chemotherapy including anthracyclines. The treatment regimen included vinorelbine (25 mg/m2 i.v.) followed by paclitaxel (135 mg/m2 i.v. as a 3-hour infusion) on day 1; vinorelbine was repeated on day 8 in the first 14 patients and on day 3 in the remaining 23 patients.

RESULTS:: Because of grade 4 neutropenia, the second dose of vinorelbine was reduced or omitted in 88% of the courses on the 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 vinorelbine was significantly higher on the days 1 and 3 schedule (13 mg/m2/wk versus 8.3 mg/m2/wk, P = 0.005). The overall response rate was 38% (95% CI: 22–55); four responses have been observed in the ten patients with absolute anthracycline resistance. The median duration of response was 6.5 months.

CONCLUSIONS:: The combination of paclitaxel and vinorelbine is a feasible and active salvage regimen in advanced breast cancer patients pretreated with anthracyclines.

breast cancer, paclitaxel, vinorelbine


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