A multi-institutional feasibility study of induction pemetrexed (Pem) plus cisplatin (Cis) followed by extrapleural pneumonectomy (EPP) and postoperative hemithoracic radiation (RT) for malignant pleural mesothelioma (MPM): Japan Mesothelioma Research Center (JMRC) 001001 trial.

Abstract

TPS285 Background: Trimodality treatment consisting of preoperative induction chemotherapy with Pem plus Cis (PC), EPP, and postoperative RT might be a promising treatment option for potentially resectable MMP, but its safety as well as efficacy remains unclear, especially in Asian population, as only limited information is currently available from a few Western studies. Methods: The Japan Mesothelioma Research Center (JMRC), supported by the Special Coordination Funds for Promoting Science and Technology from the Japanese Ministry of Education, Culture, Sports, Science, and Technology, has planned a nationwide prospective study to assess the feasibility of trimodality treatment for potentially resectable clinical stage I-III MPM patients. Based on the results of a phase I/II study of PC for unresectable MPM conducted in Japan and a single-institution pilot study of induction PC for resectable MPM, we adopted Cis at the dose of 60 mg/m2 in combination with Pem (500 mg/m2). After 3 cycles of PC, patients received EPP followed by RT (54 Gy in 30 fractions of 1.8 Gy per day). The primary endpoints are macroscopic complete resection rate and treatment-related mortality, and secondary endpoints included completion rate of trimodality treatment, adverse events, radiographic response rate of induction chemotherapy, and 2-year disease-free survival and overall survival. A total of 40 patients will be accrued over 3 years. Patient accrual rate continues as planned after activation of this trial on May 15, 2008, with registration at the UMIN Clinical Trials Registry (No. 000001154). 19 eligible patients have been enrolled as of December 31, 2009. We expect that patient registration will be completed in 2011, and this nationwide multi-institutional study will provide a variety of information on trimodality treatment in the Japanese population, which contributes to planning future prospective studies for resectable MPM. No significant financial relationships to disclose.