Preliminary results of capecitabine metronomic chemotherapy in operable triple-negative breast cancer after standard adjuvant therapy : a singlearm phase II study

Abstract EN

The aim of this study is to investigate efficacy and toxicity of 1 year of capecitabine metronomic therapy preceded by standard adjuvant chemotherapy in triple-negative breast cancer (TNBC) patients.

Methods : Between June 2010 and February 2012, 19 women with pathologically proven operable TNBC, who had received standard adjuvant chemotherapy before were enrolled.

Patients received 1 year of oral capecitabine metronomic therapy (650 mg / 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).

Results : The maximal follow-up was 46.6 months with a median of 30.1 months ± 11.525 (95 % CI ; 28.5–33.5 months).

The median DFS was 41.7 months ± 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 3 years, 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.

Conclusion : One year of capecitabine metronomic therapy preceded by standard adjuvant chemotherapy, is active and well-tolerated in TNBC patients previously treated with standard adjuvant chemotherapy.