Mesothelioma TreatmentMesothelioma Alerts
Report from Phase II Study of Vinflunine for Treating Malignant Pleural Mesothelioma
Vinflunine is showing encouraging signs for the treatment of Malignant Pleural Mesothelioma (MPM).
Treatment options for the disease of malignant pleural mesothelioma are becoming increasingly limited. This latest study shows the clinical efficacy data for vinflunine, a new microtubule inhibitor used to treat malignant pleural mesothelioma.
The study patients and methods used are summarized as follows: Patients having a diagnosis of malignant pleural mesothelioma that was histologically confirmed were eligible to enroll in this multicenter phase II trial if they did not have prior chemotherapy or radiotherapy treatments and had lesions that were measurable by Response Evaluation Criteria in Solid Tumors (RECIST). Vinflunine 320 mg/m2 by 10-minute intravenous infusion was given on day 1 of 21-day cycles. Dose and schedule modifications were made according to the National Cancer Institute's Common Toxicity Criteria version 2.0. An external, independent radiologist assessed efficacy. The Fleming one sample multiple testing procedure was used at predetermined recruitment stages of 20 and 40 patients who were considered assessable.
Study results: Sixty-seven patients enrolled in the study. Of those, five patients were not assessable for tumor response. There was a 13.8% (95% CI, 6.5% to 24.7%) response rate. The median survival rate among study participants was 10.8 months (95% CI, 7.8 to 12.0 months). The most common adverse reactions were fatigue, constipation, anemia, neutropenia, and nausea. Neutropenia and constipation were the two most common (45% and 9% of patients, respectively) of the grade 3 and 4 toxicities.
In Conclusion: Vinflunine may be delivered in high doses for patients with malignant pleural mesothelioma. The response rate and median survival rates are promising for a single agent. These data indicate that Vinflunine should continue to be evaluated for the treatment and management of malignant pleural mesothelioma.
