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A phase I clinical and pharmacological study evaluating vinflunine in combination with doxorubicin as first line treatment in metastatic breast cancer

Zaman, K. ; Durando, X. ; Baurain, J.-F ; Humblet, Y. ; Mazzeo, F. ; Bostnavaron, M. ; Meheust, N. ; Monnoyer-Favrel, S. ; Machiels, J.-P ; Bauer, J.

In: Breast Cancer Research and Treatment, 2011, vol. 127, no. 3, p. 689-696

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    Titre
    • A phase I clinical and pharmacological study evaluating vinflunine in combination with doxorubicin as first line treatment in metastatic breast cancer
    Auteur
    • Zaman, K.. Breast Center (CePO), University Hospital CHUV, Rue du Bugnon 46, 1011, Lausanne, Switzerland
    • Durando, X.. Centre Jean Perrin, Clermont-Ferrand, France
    • Baurain, J.-F. Department of Medical Oncology Cliniques universitaires Saint-Luc, Université catholique de Louvain, Brussels, Belgium
    • Humblet, Y.. Department of Medical Oncology Cliniques universitaires Saint-Luc, Université catholique de Louvain, Brussels, Belgium
    • Mazzeo, F.. Department of Medical Oncology Cliniques universitaires Saint-Luc, Université catholique de Louvain, Brussels, Belgium
    • Bostnavaron, M.. Institut de Recherche Pierre Fabre, Boulogne-Billancourt, France
    • Meheust, N.. Institut de Recherche Pierre Fabre, Boulogne-Billancourt, France
    • Monnoyer-Favrel, S.. Institut de Recherche Pierre Fabre, Boulogne-Billancourt, France
    • Machiels, J.-P. Department of Medical Oncology Cliniques universitaires Saint-Luc, Université catholique de Louvain, Brussels, Belgium
    • Bauer, J.. Breast Center (CePO), University Hospital CHUV, Rue du Bugnon 46, 1011, Lausanne, Switzerland
    Type de document
    • Postprint
    Langue
    • Anglais
    Publié dans
    • Breast Cancer Research and Treatment, 2011, vol. 127, no. 3, p. 689-696. Springer US; http://www.springer-ny.com
    Autre version électronique
    Identifiant OAI-PMH
    • oai:doc.rero.ch:318188
    Summary
    Vinfunine (VFL) is a novel bifluorinated tubulin-targeted agent of the vinca alkaloids class active in advanced stage breast cancer. We conducted a phase I study combining VFL with doxorubicin (DXR) to define the recommended dose (RD), safety, pharmacokinetic (PK) interaction and efficacy. Two schedules (day 1 every 3weeks; days 1 and 8 every 3weeks) were investigated as first line chemotherapy in metastatic breast cancer patients. Thirty-two patients received a total of 162 cycles of the VFL-DXR combination (median 6). The RDs were VFL 250mg/m2/DXR 40mg/m2 every 3weeks for schedule 1 and VFL 120mg/m2/DXR 25mg/m2 days 1 and 8 every 3weeks for schedule 2. The main dose-limiting toxicity was neutropenia. The most frequent non-hematological adverse events were nausea, fatigue, constipation, vomiting, anorexia, stomatitis and dyspnea. Objective response rate was reached in 47.1% of the patients. No PK interaction was observed. VFL-DXR combination is feasible with manageable toxicity. The antitumor activity was promising and supports further evaluation