Published in:
Oncology, 80 (2011) 3-4, Seite 262-268
Language:
English
DOI:
10.1159/000329066
ISSN:
0030-2414;
1423-0232
Origination:
Footnote:
Description:
<i>Objective:</i> To assess the efficacy of capecitabine plus docetaxel (XT) versus epirubicin plus docetaxel (ET) as first-line therapy for metastatic breast cancer (MBC). <i>Patients and Methods:</i> Patients with no prior chemotherapy for MBC were randomized to 3-weekly cycles of either XT (capecitabine 1,000 mg/m<sup>2</sup> twice daily, days 1–14; docetaxel 75 mg/m<sup>2</sup>, day 1) or ET (epirubicin 75 mg/m<sup>2</sup>, day 1; docetaxel 75 mg/m<sup>2</sup>, day 1). The primary endpoint was non-progression rate 6 months after randomization. The planned sample size was 106 patients based on a randomized, phase II selection design. <i>Results:</i> Between April 2004 and January 2007, 68 patients were randomized, giving 82% power to select the best regimen according to a 6-month non-progression rate. Slow accrual led to premature study termination. Baseline characteristics were generally well balanced between arms. The 6-month non-progression rates were 75.8% with XT versus 65.7% with ET (p<i> = </i>0.36). After 42 months’ median follow-up, median progression-free survival was 12.4 versus 6.8 months, respectively (p<i> = </i>0.040). The safety profiles were consistent with previous experience. <i>Conclusion:</i> Further larger studies are warranted to validate these results. Despite more grade 3 hand-foot syndrome, first-line XT may be a valid alternative to ET, potentially improving efficacy.