Phase II study of single agent oral vinorelbine as first-line treatment in patients with HER-2 negative metastatic breast cancer

Abstract

Previous studies indicated that oral chemotherapy is convenient and preferred by many patients. We hereby report the efficacy and safety of oral vinorelbine as first-line chemotherapy for metastatic breast cancer (MBC). Thirty-one patients with HER-2 negative MBC were enrolled between January 2007 and December 2010 in a prospective phase II trial. Patients were treated every 3weeks with oral vinorelbine 60mg/m² Days 1 and 8 for the 1st cycle and thereafter 80mg/m² Days 1 and 8 every 3weeks. Treatment was administered until disease progression or unexpected adverse event or patient refusal to continue. Primary endpoint was objective response rate (ORR); secondary endpoints were time-to-progression (TTP), overall survival (OS) and safety. Follow-up results until October 2012 are reported. Median age was 42years (range 33-75). 26 (84%) patients had 2 or more metastatic sites. A median of 6 cycles were administered (range 2-20). ORR was achieved in 9 (29%) patients including 1 complete and 8 partial responses. 12 (39%) patients had stable disease, resulting in a disease control rate of 68%. Median TTP was 5.2months [95% CI 2.8-7.5]. Median OS was 16months [95% CI 11.3-20.7]. 3 (10%) patients developed Grade 3-4 neutropenia. No events of febrile neutropenia, cardiac, renal toxicities or alopecia were recorded. Grade 3 thrombocytopenia and nausea-vomiting were reported in 2 (6%) and 5 (16%) patients, respectively. Results show a good efficacy and tolerance profile of oral vinorelbine as first-line chemotherapy for HER-2 negative MBC patients.