Multicenter phase II study of capecitabine in paclitaxel-refractory metastatic breast cancer

Purpose: Capecitabine is a novel, oral, selectively tumor-activated fluorop yrimidine carbamate, This large multicenter phase II trial tested the effic acy and safety of twice-daily oral capecitabine at 2,510 mg/m(2)/d given fo r 2 weeks followed by a I-week rest period and repeated in 3-week cycles, i n patients with paclitaxel-refractory metastatic breast cancer. Patients and Methods: Patients were ta have received at least two but not m ore than three prior chemotherapeutic regimens, one of which had to have co ntained paclitaxel given for metastatic disease. One hundred sixty-three pa tients were entered onto the study at 25 centers, and 162 patients received capecitabine. One hundred thirty-five patients had bidimensionally measura ble disease, and 27 patients had assessable disease, Results: The overall response rate was 20% (95% confidence interval, 14% to 28%), All responding patients were resistant to or had failed paclitaxel, and all had received an anthracycline, Three complete responses were seen, with complete response durations of 106, 109, and 194+ days. Median duratio n of response war 8.1 months, median survival time was 12.8 months, and the median time to disease progression was 93 days. The most common treatment- related adverse events were hand-foot syndrome, diarrhea, nausea, vomiting, and fatigue. Diarrhea (14%) and hand-foot syndrome (10%) were the only tre atment-related adverse events that occurred with grade 3 or 4 intensity in more than 10% of patients. Conclusion: Capecitabine is an active drug in the treatment of paclitaxel-r efractory metastatic breast cancer. It has a favorable toxicity profile wit h the added advantage of being an oral drug administered at home. (C) 1999 by American Society of Clinical Oncology.