Phase II trial of vinorelbine and oxaliplatin as first-line therapy in malignant pleural mesothelioma

The incidence of malignant pleural mesothelioma (MPM) is increasing. Treatment options are limited, although recently published data have offered cause for optimism. We reported a response rate of 24% with low toxicity for single agent vinorelbine (Steele JP, Shamash J, Evans MT, Gower NH, Tischkowitz MD, Rudd RM. J Clin Oncot 2000;18:3912-7). Here we report a phase II trial of vinorelbine with oxaliplatin (VO) in patients with untreated MPM. Chemotherapy consisted of vinorelbine 30mg/m(2), days 1 and 8 of a 21-day-cycle, and oxaliplatin 130mg/m(2), day 1. Treatment continued up to six cycles. The primary endpoint was objective response. Secondary endpoints were toxicity, progression-free and overall survival. Responses were asessed by modified RECIST criteria. Twenty-six patients were enrolled. There were six partial remissions, 17 patients with stable disease, and three patients with PD. Response rate was 23% (95% confidence interval 9-44%). Median number of cycles delivered was four. Progression-free survival from first treatment was 4.7 months, and overall survival was 8.8 months. One-year-survival was 27%. Toxicity (% of patients with at least one episode of grade 3 or 4 toxicity): neutropenia 18%, phlebitis 12%, malaise 12%, anorexia 12%, nausea and vomiting 12%, constipation 6%. Quality of life assessed by Rotterdam symptom checklist was associated with stabilization or improvement of psychological well-being and lung symptoms in the majority of patients, but deterioration in physical symptoms. Conclusion: VO has activity in MPM with most patients responding or having stable disease, although this doublet is associated with significant toxicity. (C) 2004 Elsevier Ireland Ltd. All rights reserved.