Trimodality therapy for malignant pleural mesothelioma : results from an EORTC phase II multicentre trial
Faculty of Medicine and Health Sciences
European respiratory journal
The European respiratory journal. - Copenhagen
, p. 1362-1369
University of Antwerp
EORTC 08031 phase II trial investigated the feasibility of trimodality therapy consisting of induction chemotherapy followed by extrapleural pneumonectomy and postoperative radiotherapy in patients with cT3N1M0 or less malignant pleural mesothelioma. Induction chemotherapy consisted of 3 courses of cisplatin 75 mg·m−2 and pemetrexed 500 mg·m−2. Non-progressing patients underwent extrapleural pneumonectomy followed by postoperative radiotherapy (54 Gy, 30 fractions). Primary endpoint was success of treatment and secondary endpoints toxicity, overall and progression-free survival. Fifty-nine patients were registered, 1 was ineligible. Median age was 57 years, cT1/T2/T3: 36/16/6, cN0/N1: 57/1. Fifty-five patients received 3 cycles of chemotherapy with only mild toxicity. Forty-six patients (79%) were operated and 42 (74%) had extrapleural pneumonectomy with a 90-day mortality of 6.5%. Postoperative radiotherapy was completed in 37 patients (65%). Grade 3/4 toxicity persisted after 90 days in 3 patients (5.3%). Median overall survival time was 18.4 months (95% CI 15.632.9) and median progression-free survival was 13.9 months (95% CI 10.917.2). Only 24 patients (42%) met the definition of success (one-sided 90% CI 0.361.00). Although feasible, trimodality therapy in patients with mesothelioma was not completed within the strictly defined timelines of this protocol and adjustments are necessary.