392 - Phase II Study of Single Agent Oral Vinorelbine (OV) as First-Line Chemotherapy (CT) in Patients (PTS) with HER-2 Negative Metastatic Breast Cancer (MBC): A Single Center Experience

Abstract

ABSTRACT Background Quality of life and pts' preferences play an important role in treatment decision-making in the metastatic setting. Previous studies indicated that Oral CT is convenient and a preferred option by many pts. We hereby report the efficacy and safety of OV as first-line CT for MBC. Patients and methods 31 pts were enrolled between January 2007 and December 2010. All pts had measurable disease, a majority (84%) relapsing after anthracyclines (ANT) and/or taxanes (TXN) adjuvant treatment, WHO PS ≤ 2, adequate bone marrow, hepatic and renal functions and no adjuvant CT within the last 6 months. Pts were treated every 3 weeks with OV 60 mg/m2 D1 and D8 for the 1st cycle and thereafter 80 mg/m2 D1 and D8 every 3 weeks in the absence of G4 neutropenia and/or febrile neutropenia. Treatment was administered until disease progression or unexpected adverse event or pt refusal to continue. Primary endpoint (EP) was Objective Response Rate (ORR); secondary EPs were TTP, OS and safety. Follow-up results until April 2012 are reported. Results Median age was 42 years (range, 33 -75); median WHO PS 1 (range, 0-2). Previous adjuvant therapy: ANT-based alone: 29%, TXN-based alone: 19%, ANT plus TXN: 36%, other: 16%. Median disease-free interval from end of previous CT was 7 months. 26 pts (84%) had 2 or more metastatic sites, liver (61%), bone (58%), lung (58%) being the most frequent sites. A median of 6 cycles were administered (range, 2-20). ORR was achieved in 9 pts (29%), including 1 complete and 8 partial responses. 12 pts (39%) had stable disease, resulting in a clinical benefit rate (CBR) of 68%. In pts pretreated by ANT, ORR was 35% and CBR was 70%. Median TTP was 3.7 months [95% CI: 2.2-5.2]. Median survival was 16 months [95% CI: 11.4-20.6]. 3 pts (10%) developed G 3-4 neutropenia. No events of febrile neutropenia, cardiac, renal toxicities or alopecia were recorded. G 3 thrombocytopenia was reported in 2 pts (6%). 5 pts (16%) developed G 3 nausea-vomiting. Conclusions: Results show a good efficacy and tolerance profile of OV as first line CT for HER-2 negative MBC pts. Similar activity was observed in the sub-group of pts pretreated by ANT. Disclosure All authors have declared no conflicts of interest.