RT Journal Article
SR Electronic
T1 Phase II trial of trimodality therapy for malignant pleural mesothelioma (EORTC 08031)
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP erj00395-2010
DO 10.1183/09031936.00039510
A1 P.E. Van Schil
A1 P. Baas
A1 R. Gaafar
A1 A.P. Maat
A1 M. van de Pol
A1 B. Hasan
A1 H.M. Klomp
A1 A.M. Abdelrahman
A1 J. Welch
A1 J. Van Meerbeeck
A1 on behalf of the EORTC Lung Cancer Group
YR 2010
UL http://erj.ersjournals.com/content/early/2010/06/04/09031936.00039510.abstract
AB 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 15.6–32.9) and median progression-free survival was 13.9 months (95% CI 10.9–17.2). Only 24 patients (42%) met the definition of success (one-sided 90% CI 0.36–1.00).Although feasible, trimodality therapy in patients with mesothelioma was not completed within the strictly defined timelines of this protocol and adjustments are necessary.