Capecitabine in the Routine Treatment of Advanced Breast Cancer: Results from a Non-Interventional Observational Study in 870 Patients

Abstract

Background: This observational study evaluated patient characteristics, treatment schedule and setting, efficacy and tolerability of capecitabine in routine clinical practice in Germany. Patients and Methods: Patients with advanced breast cancer pretreated with or ineligible for anthracycline-containing therapy were treated with capecitabine. Data were collected until disease progression or completion of 12 cycles (with long-term follow-up in progression-free patients). Results: 846 of the 876 patients enrolled between 2002 and 2007 were eligible. Capecitabine was administered as monotherapy in 64% (median starting dose 1,070 mg/m² bis in diem (b.i.d.)) and combination chemotherapy (typically with vinorelbine or docetaxel) in 36% (median starting dose 987 mg/m2 b.i.d.). Capecitabine was given as first-line therapy in 35% of patients. Objective response rate was 41% and median progression-free survival was 7.5 months. Good performance status at baseline was a significant predictor of efficacy. The most common non-hematological toxicity was hand-foot syndrome (all grades: 54%; grade 3: 7%). Myelosuppression and alopecia were substantially less common with capecitabine monotherapy than with capecitabine combination regimens. Conclusions: Capecitabine, alone or in combination, is a feasible, effective treatment for breast cancer. Our findings in real-life clinical practice compare favorably with results from interventional studies, perhaps reflecting the longer treatment duration possible at more tolerable doses.

Secondary analyses of the randomized phase III Stop&Go study: efficacy of second-line intermittent versus continuous chemotherapy in HER2-negative advanced breast cancer

“…In comparison, trials reporting second-line PFS within this review were scarce, and medians varied from 2.5 to 9.8 months depending on the investigated single-agent [10]. Observational studies on multiple lines of chemotherapy for advanced breast cancer reported median second-line PFS or TTP between 2.5 and 11.7 months [11][12][13][14][15][16][17][18][19][20][21]. However, comparison of these outcomes between trials is limited due to the large variety in (amount of) previous treatments, selection of patients, type of chemotherapy and whether or not concurrent treatments were given.…”