A phase II trial of vinflunine as monotherapy or in combination with trastuzumab as first-line treatment of metastatic breast cancer.

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.
Authors	Denise A Yardley, Michael McCleod, Fred Schreiber, Patrick Murphy, Jeffrey Patton, Dana S Thompson, Mythili Shastry, Mark Rubin, Marianne Melnik, Howard A Burris, John D Hainsworth
Journal	Cancer investigation (Cancer Invest) Vol. 28 Issue 9 Pg. 925-31 (Nov 2010) ISSN: 1532-4192 [Electronic] England
PMID	20690806 (Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)
Chemical References	Antibodies, Monoclonal Antibodies, Monoclonal, Humanized vinflunine Vinblastine Receptor, ErbB-2 Trastuzumab
Topics	Adult Aged Antibodies, Monoclonal (administration & dosage, adverse effects) Antibodies, Monoclonal, Humanized Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use) Breast Neoplasms (drug therapy, metabolism, pathology) Drug Administration Schedule Female Follow-Up Studies Humans Middle Aged Neoplasm Metastasis Neutropenia (chemically induced) Pain (chemically induced) Receptor, ErbB-2 (metabolism) Trastuzumab Treatment Outcome Vinblastine (administration & dosage, adverse effects, analogs & derivatives, therapeutic use)

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