A phase II trial of docetaxel and vinorelbine in patients with advanced breast cancer previously treated with anthracyclines.

Abstract

It was the aim of this study to evaluate the efficacy of docetaxel and vinorelbine combination in well-defined anthracycline-'exposed' or -'resistant' advanced breast cancer patients.
A phase II trial was carried out enrolling 43 advanced breast cancer patients, all previously treated with anthracyclines, both in an adjuvant or advanced setting. Docetaxel 75 mg/m(2) as 1-hour infusion and vinorelbine 25 mg/m(2) as 30-min infusion were administered on day 1, every 3 weeks.
According to an intent-to-treat analysis, the response rate was 37.2% (95% CI 22.8-51.6) in 43 patients, whereas responses were observed in 16 (1 complete response, 15 partial response) out of 39 evaluable patients (41%, 95% CI 25.6-56.5); there were 50% with first-line and 33% with second-line therapy, and 50 and 29% of patients were considered anthracycline 'exposed' and 'resistant', respectively; responses by estrogen receptor (ER) status were given in 48% (ER positive) and 25% (ER negative), and by HER2 status, in 21% (HER2 positive) and 52% (HER2 negative). Median time to progression and median overall survival were 7.7 and 28.7 months, respectively. Toxicity was generally acceptable, with grade 3 neutropenia encountered in 15 (35%) patients and grade 4 neutropenia in 1 (2%) patient. Neutropenic fever occurred in 7 patients (16%), usually short-lasting. Grade 3 mucositis was encountered in 2 patients (5%).
The combination of docetaxel and vinorelbine as a 3-weekly schedule is active and manageable in advanced breast cancer patients previously treated with anthracyclines.