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Phase II Study of Vinflunine in Malignant Pleural Mesothelioma

Denis C. Talbot, Jacques Margery, Gérard Dabouis, Graham Dark, Henry Taylor, Hélène Boussemart, Véronique Cadic, Marie-Claire Pinel, Alain Rivière, Liliane Ollivier, Pierre Ruffié

From the Churchill Hospital, Oxford; Newcastle General Hospital, Newcastle upon Tyne; Kent Oncology Centre, Kent, United Kingdom; Institut Gustave Roussy, Villejuif; Hôpital Laënnec, Saint Herblain; Institut de Recherche Pierre Fabre, Boulogne-Billancourt; CF Baclesse, Caen; and Institut Curie, Paris, France

Address reprint requests to Denis Talbot, PhD, FRCP, Cancer Research UK Medical Oncology Unit, Churchill Hospital, Headington, Oxford, OX3 7LJ, United Kingdom; e-mail: denis.talbot{at}cancer.org.uk

Purpose Malignant pleural mesothelioma (MPM) is a disease of increasing incidence for which treatment options are limited. This study reports the clinical efficacy data for vinflunine, a novel microtubule inhibitor, in MPM.

Patients and Methods Patients with a histologically confirmed diagnosis of MPM were eligible for enrollment onto this multicenter phase II trial if they had not received prior chemotherapy or radiotherapy and had measurable lesions by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Vinflunine 320 mg/m² by 10-minute intravenous infusion was administered on day 1 of 21-day cycles. Modifications of dose and schedule were made according to National Cancer Institute Common Toxicity Criteria version 2.0. Efficacy was assessed by an external, independent radiologist. The one-sample multiple testing procedure of Fleming was applied at the predetermined recruitment stages of 20 and 40 assessable patients.

Results Sixty-seven patients were enrolled. Five patients were not assessable for tumor response. The response rate was 13.8% (95% CI, 6.5% to 24.7%). The median survival was 10.8 months (95% CI, 7.8 to 12.0 months). The most common adverse events were anemia, neutropenia, fatigue, constipation, and nausea. Of grade 3 and 4 toxicities, neutropenia and constipation were the most common (45% and 9% of patients, respectively).

Conclusion Vinflunine can be delivered with high-dose intensity in patients with MPM. The response rate and median survival are encouraging for a single agent. These data suggest that vinflunine should be further evaluated in the management of MPM.

Supported by Cancer Research UK and Pierre Fabre Oncology.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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