文摘
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 Oncol 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/m2, days 1 and 8 of a 21-day-cycle, and oxaliplatin 130mg/m2, 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 assessed 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.