oral vinorelbine+Herceptin clinical trial results
Breast Cancer Res Treat. 2006 Sep 21; [Epub ahead of print] Links
Results from an observational trial with oral vinorelbine and trastuzumab in advanced breast cancer. Bartsch R, Wenzel C, Altorjai G, Pluschnig U, Bachleitner-Hoffmann T, Locker GJ, Rudas M, Mader R, Zielinski CC, Steger GG. Department of Internal Medicine I, Division of Oncology, Medical University of Vienna, 18-20 Waehringer Guertel, A-1090, Vienna, Austria, guenther.steger@meduniwien.ac.at. 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 >/= 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. PMID: 17028979 [PubMed - as supplied by publisher] |
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