NO ADVANTAGE OF VINFLUNINE FOR BREAST CANCER

Cancer Invest. 2010 Aug 6. [Epub ahead of print]
A Phase II Trial of Vinflunine As Monotherapy or in Combination with Trastuzumab as First-Line Treatment of Metastatic Breast Cancer.
Yardley DA, McCleod M, Schreiber F, Murphy P, Patton J, Thompson DS, Shastry M, Rubin M, Melnik M, Burris HA, Hainsworth JD.

Sarah Cannon Research Institute, Nashville, Tennesee, USA,1 Tennessee Oncology, PLLC, Nashville, Tennesee, USA,2 Florida Cancer Specialists, Fort Myers, Florida, USA,3 Watson Clinic, Lakeland, Florida, USA,4 Grand Rapids Clinical Oncology Program, Grand Rapids, Michigan, USA5.
Abstract

ABSTRACT We investigated the microtubulin inhibitor vinflunine-with trastuzumab in human epidermal growth factor receptor-2 (HER2)-positive patients-as first-line metastatic breast cancer therapy. HER2-negative patients received vinflunine on day 1; HER2-positive patients received vinflunine/trastuzumab every 21 days. Forty-eight patients in each treatment group were planned; the sponsor terminated the study early. Thirty-two evaluable patients (vinflunine, 11; vinflunine/trastuzumab, 21) were enrolled. In HER2-positive patients, vinflunine/trastuzumab produced an objective response rate (33%), clinical benefit rate (71%), and progression-free survival (6.2 months). Grade-3/4 neutropenia occurred in 14 (44%) patients; gastrointestinal toxicities were common and six patients were hospitalized for treatment-related toxicity. The vinflunine/trastuzumab combination was active and well tolerated, but our results do not suggest advantages over taxane/trastuzumab or vinorelbine/trastuzumab.