Final results of a phase II clinical trial of weekly docetaxel in combination with capecitabine in anthracycline-pretreated metastatic breast cancer.

摘要: The addition of capecitabine to docetaxel on a 3-week schedule resulted in superior response rate, increased time progression (TTP), and improved overall survival patients with anthracycline-pretreated metastatic breast cancer (MBC). Because the toxicity profile weekly differs from standard 21-day schedule, we performed phase I/II trial test efficacy safety combination given for 14 days every 21 days. I study identified doses (30 mg/m2 weekly) (900 twice daily 1-14 days) used II. Twenty female measurable or assessable MBC were enrolled. Eighteen had previously received anthracyclines; 2 contraindications anthracyclines. Patients remained maximum eight cycles until tumor unacceptable occurred; assessments scheduled after cycle 2, 5, 8. Seventeen assessed 2; 3 subjects (18%) partial (PR), 9 stable disease (53%; SD), 5 (29%) progressive (PD). Ten 5. Two (20%) PR, (50%) SD, (30%) PD. most common grade toxicities nail loss (45%), asthenia (30%), hand-foot syndrome led discontinuation 10 patients. median treatment failure was weeks TTP 26 weeks. duration SD 16 82 This day has activity; however, discourages use this lieu docetaxel/capecitabine regimen.