Preliminary results of capecitabine metronomic chemotherapy in operable triple-negative breast cancer after standard adjuvant therapy – A single-arm phase II study

Abstract

PurposeThe aim of this study is to investigate efficacy and toxicity of 1year of capecitabine metronomic therapy preceded by standard adjuvant chemotherapy in triple-negative breast cancer (TNBC) patients. MethodsBetween June 2010 and February 2012, 19 women with pathologically proven operable TNBC, who had received standard adjuvant chemotherapy before were enrolled. Patients received 1year of oral capecitabine metronomic therapy (650mg/m2, twice every day), after standard adjuvant chemotherapy and radiotherapy if indicated. The primary endpoints of this study were disease-free survival rates (DFS) and safety profile. Secondary end point was overall survival (OS). ResultsThe maximal follow-up was 46.6months with a median of 30.1months ±11.525 (95% CI; 28.5–33.5months). The median DFS was 41.7months ±2.7 (95% CI; 36.5–46.9). No one developed locoregional recurrence. The actuarial rate of DFS was 88.8% and 82.05% at 2 and 3years, respectively. At the time of the analyses, no patients had died and the median OS was not reached. Treatment-related adverse events were manageable with only 1 patient (5.3%) suffering from Grade 3/4 hand-foot syndrome and another 1 patient (5.3%) suffering from Grade 3 diarrhea. No Grade 3/4 hematologic toxicity was recorded. All patients received full doses of capecitabine throughout the study and dose reduction was not required in any of our patients. ConclusionOne year of capecitabine metronomic therapy preceded by standard adjuvant chemotherapy, is active and well-tolerated in TNBC patients previously treated with standard adjuvant chemotherapy.