Navelbine and Capecitabine (NavCap) versus NavCap Followed by Weekly Docetaxel as First-Line Treatment for Patients with HER-2 Negative Metastatic Breast Cancer

Abstract

Background and Aim: There is an ongoing effort to optimize the management of HER-2 negative metastatic breast cancer (MBC). The aim of this study was to assess the treatment outcome of vinorelbine combines with capecitabine (NavCap) compared to the same combination followed by sequential single agent docetaxel in patients with HER-2 negative MBC.Patients and Methods: Patients with HER-2 negative MBC previously treated with anthracycline in the adjuvant setting were enrolled in this prospective phase II study. Patients received vinorelbine 25mg/m2 on day 1 and 8 combined with pecitabine 825mg/m2 twice daily on days 1 to 14 (NavCap) every 3 weeks for 4 cycles. Patients with complete response (CR), partial response (PR) and stable disease (SD) were randomized to two arms. Arm 1 received another 4 cycles of NavCap and arm 2 received docetaxel 25mg/m2 weekly for 12 weeks.Results: From March 2012 to March 2014, 35 patients were enrolled in the study. Thirty-one patients were randomized to arm 1 (16 patients) and arm 2 (15 patients). The overall response rate was 50% and 60% in arms1 and 2, respectively. With a median follow-up of 15 month, the median time to tumor progression was 13 and 12 months and the median survival were 17 and 16 months for arms 1 and 2, respectively. The most frequent treatment related toxicities in arm 1 were: grade 3- 4 neutropenia (12.5%), anemia (6.25%) and grade 2 nausea and vomiting (12.5%). In arm 2, grade 3- 4 neutropenia (6.7%), anemia (6.7%) and grade 2 alopecia (13.3%) were reported.Conclusion: Both NavCap and NavCap followed by docetaxel schedules appear to be effective and well-tolerated regimens as first line treatment for Egyptian HER-2 negative MBC.