Multicentre, phase II study evaluating capecitabine monotherapy in patients with anthracycline- and taxane-pretreated metastatic breast cancer.

摘要: Treating patients with anthracycline- and taxane-pretreated metastatic breast cancer (MBC) represents a significant challenge to oncologists. The tumour-activated oral fluoropyrimidine, capecitabine, is the only treatment approved for these patients. Our study evaluated efficacy, safety impact on quality of life (QOL) capecitabine in this setting. Patients (n=126) received 1250 mg/m 2 twice daily, days 1–14, followed by 7-day rest period. Median time progression was 4.9 months (95% Confidence Interval (CI): 4.0–6.4). Thirty-five (28%) achieved an objective response CI: 20–36%), including five (4%) complete responses. overall survival 15.2 13.5–19.6 months). Capecitabine demonstrated favourable profile, low incidence treatmentrelated grade 3/4 adverse events. most common events were hand–foot syndrome gastrointestinal effects. QOL assessment showed that associated increase mean Global Health Score. active, well tolerated improves cancer. Based consistently high activity clinical trials, has become reference # 2003 Elsevier Ltd. All rights reserved.