Pemetrexed Plus Cisplatin or Pemetrexed Plus Carboplatin for Chemonaïve Patients with Malignant Pleural Mesothelioma: Results of the International Expanded Access Program

摘要: Introduction Previously published results from a randomized phase III study of pemetrexed plus cisplatin in patients with malignant pleural mesothelioma (MPM) demonstrated significant survival benefit and higher response rate compared cisplatin. Although was under review by regulatory agencies, an International Expanded Access Program (EAP) provided more than 3000 access to single-agent or combination carboplatin 13 countries. This manuscript reports the safety efficacy data nonrandomized open-label chemonaive receiving platinum EAP. Methods Patients histologically confirmed MPM, not amenable curative surgery, received 500 mg/m 2 either 75 AUC 5, once every 21 days standard premedication. Efficacy were recorded at end participation. Results A total 1704 ( n = 843) 861) evaluated for safety. The evaluable population consisted 745 group 752 whom physician-reported tumor available. 26.3% 21.7% group, similar 1-year rates (63.1% versus 64.0%) median time progressive disease (7 months 6.9 months). most common grade 3/4 hematologic toxicity neutropenia 23.9% 36.1% group. Conclusion large EAP activity demonstrating clinically rates.