Capecitabine (X) in the routine treatment of advanced breast cancer (BC): Results from a large (n = 870) noninterventional study

Abstract

e12021 Background: This observational study evaluated patient (pt) characteristics, treatment schedule and setting, efficacy and tolerability of X in routine clinical practice in Germany. Methods: Pts with advanced BC pretreated with or ineligible for anthracycline-containing therapy received X. As there was no specific protocol for X administration, data on dose, treatment duration, treatment delays/interruptions, and concomitant anticancer therapy were collected as well as efficacy data. Pts were followed until disease progression or completion of 12 cycles (with long-term follow-up in pts who were progression-free after 12 cycles). Results: Between 2002 and 2007, 870 pts were recruited from 135 centers, of whom 846 were eligible. Most pts (62%) were aged 50–69 years and 64% had received prior taxane therapy. X was given as monotherapy in 64% (median starting dose 1070 mg/m2 bid) and combination chemotherapy in 36% (median starting dose 987 mg/m2 bid), typically with vinorelbine or docetaxel. Generally, pts receiving X alone were slightly older and were more likely to have hormone receptor-positive disease than those receiving combination therapy. 35% of pts received X as first-line therapy. Pts received a median of 7 cycles; 26% received ≥12 cycles. Overall response rate (RR) was 41% (95% CI: 38–45) and median progression-free survival (PFS) was 7.5 months (95% CI: 7.1–8.3). RR was higher with combination therapy (49%) than monotherapy (37%), but PFS was similar in the two subgroups. Good performance status at baseline was a significant predictor of efficacy. The most common non-hematologic adverse event was hand-foot syndrome (all grades: 54%; grade 3: 7%), leading to premature treatment discontinuation in 6%. Myelosuppression and alopecia were substantially less common when X was administered as monotherapy than as combination chemotherapy. Conclusions: X, either alone or in combination, is a feasible and effective treatment for advanced BC. Our findings in real-life clinical practice compare favorably with results from interventional studies, perhaps reflecting the longer treatment duration possible at a more tolerable dose. No significant financial relationships to disclose.