Results from an observational trial with oral vinorelbine and trastuzumab in advanced breast cancer.

PURPOSE: We evaluated the efficacy and tolerability of oral vinorelbine plus trastuzumab (OV + T) in Her2 positive advanced breast cancer as first line chemotherapy or after progressing on earlier treatment. PATIENTS AND METHODS: Thirty consecutive patients (median age: 59 years) were included. Patients received OV in a dose of 60 mg/m(2) on day 1 and 8, q=21, without dose escalation. Trastuzumab was administered every 3 weeks at a dose of 6 mg/kg bodyweight after a loading dose of 8 mg/kg. Response was evaluated every three cycles using UICC criteria. Time to progression (TTP) and overall survival (OS) were estimated using the Kaplan-Meier product limit method. A multivariate analysis was performed to evaluate factors potentially influencing response rate and TTP. RESULTS: Median time of observation was 20 months. We observed a complete response in 18% of patients, partial remission in 50%, stable disease >or= 6 months in 21%, and progressive disease in 11%. TTP was median 9 months. OS was not reached. Response rate and TTP were influenced by line of treatment only. The main toxicities consisted of neutropenia and nausea. CONCLUSIONS: OV + T appears to be an effective and safe treatment option in advanced breast cancer at the dose and schedule chosen.