Weekly paclitaxel plus capecitabine in advanced breast cancer patients: Dose-finding trial of GOIRC and GOL

Abstract

Background: Paclitaxel and capecitabine have demonstrated a synergic effect and significant antitumor activity in patients with advanced breast cancer. A weekly schedule of paclitaxel obtained a response rate of 50 - 68% in advanced breast cancer and less serious side-effects. Patients and methods: Thirty-two patients with advanced breast cancer pretreated with chemotherapy were enrolled in a dose-finding trial to determine the maximum tolerated dose (MTD) and the dose-limiting toxicity (DLT) of paclitaxel given on days 1, 8 and 15 of each cycle combined with capecitabine given twice daily from day 1 through day 14, every 21 days. Three patients were recruited at one of six dose levels (paclitaxel 70 - 100 mg/m2, capecitabine 1650 - 2500 mg/m2). Results: Thirty-two patients were accrued and 31 were evaluated for toxicity. One DLT has been experienced at level VI as diarrhea grade 3. We determined dose level V as the MTD, but we recommend dose level IV for phase II studies (capecitabine 1250 mg/m2 orally twice daily plus paclitaxel 80 mg/m2 intravenously weekly), owing to cumulative toxicity at level V. The objective response rate was 43%. Conclusions: Weekly paclitaxel plus capecitabine is a safety and active chemotherapy in previously treated metastatic breast cancer. © 2005 European Society for Medical Oncology.