A Phase II Trial of Vinflunine As Monotherapy or in Combination with Trastuzumab as First-Line Treatment of Metastatic Breast Cancer

Denise A. YardleySarah Cannon Research Institute, Nashville, Tennesee, USA, Tennessee Oncology, PLLC, Nashville, Tennesee, USA, Florida Cancer Specialists, Fort Myers, Florida, USA, Watson Clinic, Lakeland, Florida, USA, Grand Rapids Clinical Oncology Program, Grand Rapids, Michigan, USA

Michael McCleodSarah Cannon Research Institute, Nashville, Tennesee, USA, Tennessee Oncology, PLLC, Nashville, Tennesee, USA, Florida Cancer Specialists, Fort Myers, Florida, USA, Watson Clinic, Lakeland, Florida, USA, Grand Rapids Clinical Oncology Program, Grand Rapids, Michigan, USA

Fred SchreiberSarah Cannon Research Institute, Nashville, Tennesee, USA, Tennessee Oncology, PLLC, Nashville, Tennesee, USA, Florida Cancer Specialists, Fort Myers, Florida, USA, Watson Clinic, Lakeland, Florida, USA, Grand Rapids Clinical Oncology Program, Grand Rapids, Michigan, USA

Patrick MurphySarah Cannon Research Institute, Nashville, Tennesee, USA, Tennessee Oncology, PLLC, Nashville, Tennesee, USA, Florida Cancer Specialists, Fort Myers, Florida, USA, Watson Clinic, Lakeland, Florida, USA, Grand Rapids Clinical Oncology Program, Grand Rapids, Michigan, USA

Jeffrey PattonSarah Cannon Research Institute, Nashville, Tennesee, USA, Tennessee Oncology, PLLC, Nashville, Tennesee, USA, Florida Cancer Specialists, Fort Myers, Florida, USA, Watson Clinic, Lakeland, Florida, USA, Grand Rapids Clinical Oncology Program, Grand Rapids, Michigan, USA

Dana S. ThompsonSarah Cannon Research Institute, Nashville, Tennesee, USA, Tennessee Oncology, PLLC, Nashville, Tennesee, USA, Florida Cancer Specialists, Fort Myers, Florida, USA, Watson Clinic, Lakeland, Florida, USA, Grand Rapids Clinical Oncology Program, Grand Rapids, Michigan, USA

Mythili ShastrySarah Cannon Research Institute, Nashville, Tennesee, USA, Tennessee Oncology, PLLC, Nashville, Tennesee, USA, Florida Cancer Specialists, Fort Myers, Florida, USA, Watson Clinic, Lakeland, Florida, USA, Grand Rapids Clinical Oncology Program, Grand Rapids, Michigan, USA

Mark RubinSarah Cannon Research Institute, Nashville, Tennesee, USA, Tennessee Oncology, PLLC, Nashville, Tennesee, USA, Florida Cancer Specialists, Fort Myers, Florida, USA, Watson Clinic, Lakeland, Florida, USA, Grand Rapids Clinical Oncology Program, Grand Rapids, Michigan, USA

Marianne MelnikSarah Cannon Research Institute, Nashville, Tennesee, USA, Tennessee Oncology, PLLC, Nashville, Tennesee, USA, Florida Cancer Specialists, Fort Myers, Florida, USA, Watson Clinic, Lakeland, Florida, USA, Grand Rapids Clinical Oncology Program, Grand Rapids, Michigan, USA

Howard A. BurrisSarah Cannon Research Institute, Nashville, Tennesee, USA, Tennessee Oncology, PLLC, Nashville, Tennesee, USA, Florida Cancer Specialists, Fort Myers, Florida, USA, Watson Clinic, Lakeland, Florida, USA, Grand Rapids Clinical Oncology Program, Grand Rapids, Michigan, USA

John D. HainsworthSarah Cannon Research Institute, Nashville, Tennesee, USA, Tennessee Oncology, PLLC, Nashville, Tennesee, USA, Florida Cancer Specialists, Fort Myers, Florida, USA, Watson Clinic, Lakeland, Florida, USA, Grand Rapids Clinical Oncology Program, Grand Rapids, Michigan, USA

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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.

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A Phase II Trial of Vinflunine As Monotherapy or in Combination with Trastuzumab as First-Line Treatment of Metastatic Breast Cancer

Sarah Cannon Research Consortium participating sites

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A Phase II Trial of Vinflunine As Monotherapy or in Combination with Trastuzumab as First-Line Treatment of Metastatic Breast Cancer

ABSTRACT

APPENDIX

Sarah Cannon Research Consortium participating sites

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