Phase II study of vinorelbine in patients with malignant pleural mesothelioma

Purpose: To evaluate the response rate and impact on quality of life of vin orelbine given as cycles of 30 mg/m(2) weekly for 6 weeks to patients with malignant pleural mesothelioma. Patients and Methods; Twenty-nine patients with histologically proven malig nant pleural mesothelioma were enrolled (26 male patients and three female patients; median age, 58 years [range, 29 to 77 years]). Seventeen patients had epithelioid tumors, two had sarcomatoid tumors, and 10 had biphasic tu mors. The International Mesothelioma Interest Group staging system was used : one patient had stage Ib disease, 10 had stage II disease, eight had stag e III disease, and 10 had stage IV disease. Patients were treated with week ly injections of vinorelbine 30 mg/m(2). A cycle consisted of six weekly in jections. The new guidelines to evaluate the response to treatment in solid tumors were used. Responses were measured by spiral computed tomography sc an. Results: All twenty-nine patients held measurable disease and were assessed for response. There were seven partial responses (24% [95% confidence inte rval, 10% to 44%]), 16 patients had stable disease (55%), and six patients had disease progression on therapy (21%). The median number of vinorelbine injections was 12 (range, 2 to 30). Quality-of-life analyses showed a benef it for vinorelbine therapy. Conclusion: Vinorelbine shows promise in the palliation of patients with ma lignant pleural mesothelioma, The relatively low toxicity of the drug sugge sts that trials of vinorelbine in combination with other agents should be f easible. (C) 2000 by American Society of Clinical Oncology.