A phase II EORTC study of temozolomide in patients with malignant pleural mesothelioma

The aim of this study was to investigate the anti-tumour activity of temozolomide in patients with malignant pleural mesothelioma. 27 chemotherapy-naive patients with histologically-proven malignant mesothelioma were treated with temozolomide 200 mg/m(2)/day, given orally on days 1 5 of each 28-day cycle. Therapy continued up to 10 cycles unless disease progression or excessive toxicity mandated discontinuation. Toxicity, symptom improvement and pain intensity were regularly assessed. With a median relative dose intensity of 97%, toxicity was moderate with grade 3 or more nausea, vomiting, thrombocytopenia, leucocytopenia, neutropenia, febrile leucocytopenia, arthralgia, infection and fever with infection occurring in 13, 13, 10, 3, 7 and 3% of patients for the remaining events, respectively. Overall, I objective response was observed (response rate 4%, 95% Confidence Interval (Cl): 0.1-19), Median Survival was 8.2 months. Symptom assessment showed no improvement and an increase of pain was observed during the study. Thus, oral temozolomide is an inactive agent in malignant mesothelioma. (C) 2002 Elsevier Science Ltd. All rights reserved.