A Clinical Phase II Study of Oral Vinorelbine in HER-2 Negative Metastatic Breast Cancer

Abstract

Background: Oral vinorelbine, produce an effective and viable treatment option in both the first and secondline settings for patients with metastatic breast cancer (MBC). The present phase II single institution study designed with an aim to analyze the efficacy and safety of oral vinorelbine as first-line therapy for patients with metastatic breast cancer (MBC) Patients and methods: Twenty-one women aged >18 years with histopathologically confirmed HER-2 negative MBC, were enrolled to receive oral vinorelbine given as a single agent at doses of (60 mg/m2, day 1 and 8 of a 3-week cycle and thereafter 80 mg/m2 of days 1 and 8). No prior chemotherapy was allowed for treatment of metastatic disease, patients who received oral vinorelbine as adjuvant or neoadjuvant therapy were excluded. Results: Objective response was observed in 28.7% of patients (6/21), and tumour control rate was 66.8% (14/21). Only one patient (4.8%) experienced complete response following treatment. The median progressionfree survival (PFS) and overall survival (OS) were 6 and 16 months, respectively. The 1-year OS and PFS rates were 64.1% and 16.2%, respectively. Most adverse events were mild to moderate. The most common grade 3/4 hematological toxicities were neutropenia (9.5%), while the most common grade 3/4 non-hematological toxicities were nausea/vomiting (14.3%). No treatment-related mortality was noted in this cohort. Conclusion: Oral vinorelbine as first-line therapy in patients with MBC appeared to offer an acceptable clinical profile and easy to administer in outpatients. The substitution of oral vinorelbine for intra-venous form is not only feasible, but may be in the patients’ best interest.