Thalidomide in patients with malignant pleural mesothelioma

Objectives: The purpose of this study was to describe the experience with the anti-angiogenic agent thalidomide in the treatment of patients with a malignant pleural. mesothelioma (MPM). Materials and methods: Patients with a histological confirmed diagnosis of malignant mesothelioma received thalidomide orally at night. Increasing doses of 100, 200 or maximally 400 mg were given till progression or unacceptable toxicity. Patients that did not show signs of progression for >= 6 months were considered responders. Neurological examination included the use a sensory nerve action potential (SNAP) test. Results: Forty patients were evaluable for toxicity and efficacy. Twenty of them (50%) had received prior treatment. Thirty patients (75%) received a dose of 400 mg, 11 (37%) required dose reduction and 10 patients were confined to a dose of 200 mg or less. The major toxicity elicited by thalidomide concerned constipation (18/40 grade I and II) and two patients developed grade II neurotoxicity. A decline in SNAP test (> 50%) did not seem to be related to the extent of neurological complaints. Eleven patients (27.5%) showed disease stabilization for > 6 months and the median survival was 230 days (CI 130-330). Conclusions: The advised dose for future studies in these patients is 200 mg/day. At this dose level, the toxicity is mild and routine monitoring of neurological toxicity (SNAP test) can be omitted. The percentage of patients seen with prolonged disease stabilization upon thalidomide treatment warrants phase III studies in MPM. (c) 2004 Elsevier Ireland Ltd. All rights reserved.