Paclitaxel in combination with vinorelbine in pretreated advanced breast cancer patients

A. Michelotti, A. Gennari, B. Salvadori, P. G. Giannessi, E. Baldini, C. Tibaldi, M. Da Prato, P. F. Conte

Research output: Contribution to journalArticlepeer-review

Abstract

This phase II study combined paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) 135 mg/m2 by 3-hour infusion on day 1 and vinorelbine 25 mg/m2 on days 1 and 8 (in the first 14 patients) or on days 1 and 3 (in the subsequent 20 patients). The courses were repeated every 3 weeks. The second vinorelbine dose (on days 3 or 8) was reduced or omitted according to the toxicities encountered. Thirty-four patients have been treated to date; 21 had received one prior regimen of chemotherapy, 11 had two prior regimens, and two had three prior regimens. Only two patients (6%) had not been exposed to anthracyclines. One hundred twenty-six courses have been administered: 52 with vinorelbine given on days 1 and 8, and 74 with vinorelbine administered on days 1 and 3. The most frequent toxicity was grade 4 neutropenia, which occurred in 64% of the courses; 13 episodes of febrile neutropenia have been reported in eight patients. Filgrastim was administered in 43% of the courses because of febrile neutropenia or delayed recovery (>72 hours) from grade 4 neutropenia. Mucositis was observed in 18% of the courses (12% grade 1, 3% grade 2, and 3% grade 3). The dose of vinorelbine was reduced or omitted in 86% of courses with the clays 1 and 8 schedule, and in 48% of courses with the days 1 and 3 schedule. Among 28 evaluable patients, two complete and 10 partial responses have been observed (response rate, 43%; 95% confidence interval, 19% to 51%). Median duration of response is 5 + months (range, 1 to 15 months). In conclusion, this combination is active and has acceptable toxicities in anthracycline- pretreated breast cancer patients. The delivered dose intensity of vinorelbine is higher with the schedule adopted later in the study, with vinorelbine given on days 1 and 3.

Original languageEnglish
Pages (from-to)38-40
Number of pages3
JournalSeminars in Oncology
Volume23
Issue number5 SUPPL. 11
Publication statusPublished - 1996

ASJC Scopus subject areas

  • Oncology

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