ESSEN, Germany—The combination of capecitabine(Drug information on capecitabine) (Xeloda) plus vinorelbine (Navelbine) is feasible and has a favorable toxicity profile in anthracycline-pretreated or taxane-pretreated advanced breast cancer, according to results of a recent phase I/II study. "The response rate over 50% is very promising," noted Udo Vanhoefer, MD, professor of medicine at University of Essen Medical School in Germany. "We had no alopecia, the incidence of hand-foot syndrome is very low, and the dose density is very high at 90% and very acceptable for this combination."
The median age of the 33 patients in this study was 54 years (range 30 to 69). The most common sites of metastases were liver, in 21 patients (64%), and bone, in 17 patients (51%). All but one patient received prior anthracyclines, and 12 (36%) had prior taxane exposure.
All patients received the combination of vinorelbine, which has significant activity in advanced breast cancer, and capecitabine, which is a tumor-activated oral fluoropyrimidine. Previously, researchers had shown vinorelbine plus infusional 5-FU to be active in metastatic breast cancer.
Vinorelbine Dose Reduced
Overall response rate among the 29 evaluable patients was approximately 51%, including a 10% complete response rate (3 patients) and a 41% partial response rate (12 patients). Another 14% (4 patients) had stable disease. Median time to progression was 32 weeks.
The main toxicity was neutropenia, and other toxicities were mild. Investigators reported only one case of grade 2 hand-foot syndrome.
Median relative dose density was 0.9 for both capecitabine and vinorelbine. The dosing schedule was vinorelbine IV on days 1, 8, 22, and 29, with capecitabine orally twice daily for two 2-week periods, starting on days 1 and 22 of the 42-day (6 week) cycle.
