Vinorelbine plus platinum compared to vinorelbine plus capecitabine in treatment of patients with metastatic triple negative breast cancer previously treated with anthracycline and taxane: a prospective randomized study

Introduction. This study aims to investigate the efficacy and tolerability of the vinorelbine-based combination chemotherapy with either cisplatin or capecitabine in metastatic triple-negative breast cancer (mTNBC) pretreated with anthracycline and taxane. Material and methods. This is an open-labeled randomized prospective single-institute study, that included all patients who received chemotherapy for mTNBC in the period between 1st of July 2016 and 30th of June 2017 and were pretreated with anthracycline and taxane. Patients were randomized to either vinorelbine 25 mg/m2 I.V on days 1 and 8 plus oral capecitabine 1000 mg/m2 twice daily, on days 1–14 (NX); or vinorelbine 25 mg/m2 I.V on days 1 and 8 plus cisplatin 75 mg/m2 (NP), every 21 days. The primary endpoint was time to progression (TTP), whereas the secondary endpoints were objective response rate (ORR), safety, and overall survival (OS). Results. Median TTP was 9.9 months with NP vs. 8 months with NX, (p = 0.22). ORR was 40% with NP vs . 36% with NX, (p = 0.77). Median OS was 13 months with NP vs . 13.2 months with NX (p = 0.599). Both regimens demonstrated similar rates of grade ≥ 3 vomiting and neutropenia. A higher incidence of thrombocytopenia, tinnitus, and kidney function alteration were reported with NP. A higher incidence of anorexia, diarrhea, mucositis, and hand-foot syndrome were reported with NX. Conclusions. Vinorelbine-based combination chemotherapy regimens with either cisplatin or capecitabine are active in the treatment of mTNBC pretreated with anthracycline and taxane with manageable toxicity profiles. Both regimens have comparable TTP, ORR, OS, and safety profiles.