Phase Ii Trial Of Neoadjuvant Pemetrexed Plus Cisplatin Followed By Surgery And Radiation In The Treatment Of Malignant Pleural Mesothelioma (Mpm)

7090 Background: Combined modality approaches to therapy, including surgery (S) and radiation, have proved feasible and are becoming one of the standards of care in MPM. This study was designed to assess the efficacy of the combination of neoadjuvant pemetrexed+cisplatin, extrapleural pneumonectomy (EPP) and hemithoracic radiation (HTR) (trimodality [TM] therapy) in MPM. Methods: This was a multicenter, phase II, open-label study with event-free survival (EFS) (defined as time from enrollment to first observation of disease progression, death due to any cause or early treatment discontinuation) as the primary endpoint. Between 2005 and 2008, 56 patients (pts) with MPM (T1-3, N0-2) were screened, of whom 54 were enrolled (87% male; median age  63 [range 39-75] years; ECOG PS 0-1; adequate organ function). Pre-operative pemetrexed 500 mg/m2+cisplatin 75 mg/m2 IV was given every 21 days x 3 cycles, plus folic acid, vitamin B12 and dexamethasone, followed by EPP and HTR (total dose 54 Gy). After 2 deaths due ...