Multicenter, Phase II study of capecitabine in taxane-pretreated metastatic breast carcinoma patients

BACKGROUND. Capecitabine is an oral, tumor-targeted fluoropyrimidine carbam ate with high activity in metastatic breast carcinoma and in paclitaxel-pre treated metastatic breast carcinoma. METHODS. The current multicenter, Phase II trial assessed the efficacy and safety of intermittent oral capecitabine, 1255 mg/m(2) twice daily (2 weeks of treatment followed by a 1-week rest period), in patients with metastati c breast carcinoma in whom prior taxane therapy had failed. All patients ha d failed treatment or had disease that was refractory to two or three previ ous chemotherapy regimens, one of which contained a taxane. Nearly all pati ents (96%) also had received prior anthracycline chemotherapy. Seventy-five patients were recruited at 5 centers, 74 of whom received treatment. RESULTS. The overall response rate was 26%, with response rates of 27% and 20%, respectively, in the subgroups of patients previously pretreated with paclitaxel (n = 47) or docetaxel (n = 27). The median survival was 12.2 mon ths, the median duration of response was 8.3 months, and the median time to disease progression was 3.2 months. The most common treatment-related adve rse events (all grades) were hand-foot syndrome (62%), diarrhea (58%), naus ea (55%), emesis (37%), and stomatitis (34%). However, the majority were mi ld to moderate in intensity and only three patients experienced Grade 4 (ac cording to the National Cancer Institute of Canada Common Toxicity criteria ) adverse events. The only Grade 3 treatment-related adverse events reporte d in greater than or equal to 10% of the patients were hand-foot syndrome ( 22%), diarrhea (16%), and stomatitis (12%). Myelosuppression and alopecia w ere rare, and there were no reported treatment-related deaths. CONCLUSIONS. The results of the current study demonstrate that capecitabine is an effective and well tolerated treatment in patients with taxane-refra ctory or taxane-failing metastatic breast carcinoma. In addition, it is a c onvenient, orally administered drug, which makes it an attractive agent for use in outpatient treatment. (C) 2001 Americana Cancer Society.