A multicenter, randomized phase III maintenance study of thalidomide (arm A) versus observation (arm B) in patients with malignant pleural mesothelioma (MPM) after induction chemotherapy.

7006 Background: Standard chemotherapy treatment does not lead to long-term survival; new treatment approaches are required. MPM is known for its high vessel count and levels of vascular growth factors. Suppression of the neo-vasculature by adding thalidomide in the maintenance setting might lead to improved progression free survival (PFS). We here report the final results of PFS, overall survival (OS) and toxicity. Methods: Patients with pemetrexed (500 mg/m2) and carboplatin (AUC 5) or cisplatin (75mg/m2)(q3) for ≥ 4 courses and no signs of progression were eligible. After obtaining informed consent patients were randomized to receive thalidomide 200 mg/day orally (A) or no treatment (B). CT scanning of the thorax and physical examination was performed every 2 months or earlier. PFS and OS were calculated from start of randomization. A number of 190 events were required to show an improvement of 50% in PFS. Results: From 05/2004 until 12/2009 222 patients from 8 Dutch and 4 Australian centers were inclu...