Efficacy and safety of first- or second-line irinotecan, cisplatin, and mitomycin in mesothelioma

BACKGROUND. Malignant pleural mesothelioma (MPM) is a rapidly progressive lethal tumor. Treatment options remain limited and the outcome in recurrent disease is poor. METHODS. A Phase II open-label noncomparative study was conducted to assess the safety and efficacy of the triplet combination irinotecan, cisplatin, and mito-mycin-C (IPM) chemotherapy in untreated patients and in those with previous exposure to chemotherapy. RESULTS. In 62 patients an objective response rate of 25% was observed. In the first-line setting progression-free survival measured 6.4 months (95% confidence interval [CI]: 4.5-7.3) and overall survival was 10.8 months (95% CI: 7.9-13.7). In the second-line setting progression-free survival was 7.3 months (95% CI: 3.4-11.2) and overall survival was also 7.3 months (95% CI: 4.8-9.8). Psychosocial well-being improved during chemotherapy and the main toxicity observed was neutropenia (40%). CONCLUSIONS. IPM appeared to have a reasonable response rate with an acceptable toxicity profile in the first- and second-line treatment of MPM. Cancer 2007;109:93-9. (c) 2006 American Cancer Society.