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Volume 2008, Article ID 412503, 7 pages
Clinical Study

Phase II Study of Temozolomide and Thalidomide in Patients with Unresectable or Metastatic Leiomyosarcoma

1Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY 10065, USA
2Mesothelioma Applied Research Foundation, Santa Barbara, CA 93190, USA
3Department of Biostatistics, Mailman School of Public Health, Columbia University, New York, NY 10032, USA
4Division of Medical Oncology, Department of Medicine, Columbia University Medical Center, Herbert Irving Pavilion, 161 Fort Washington Avenue, New York, NY 10032, USA

Received 6 May 2008; Revised 17 August 2008; Accepted 29 September 2008

Academic Editor: Charles Scoggins

Copyright © 2008 Michelle S. Boyar et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.


We assessed the efficacy of combined temozolomide and thalidomide in patients with unresectable or metastatic leiomyosarcoma in a phase II single-institution trial. Twenty-four patients were enrolled. Temozolomide (150 mg/ /day for 7 days every other week) was administered with concomitant thalidomide (200 mg/day), and continued until unacceptable toxicity or disease progression. There were no complete responses and two (10%) partial responses. Five patients (24%) had stable disease for at least six months. Fourteen patients (67%) progressed after a median of two-month treatment. The median overall survival (twenty-two assessable patients) was 9.5 months [95% CI 7–28 months]. There were no treatment-related deaths or CTC grade 4 toxicities. Thirteen patients were dose-reduced or discontinued thalidomide due to toxicity. In conclusion, this combination of temozolomide and thalidomide provided disease stabilization in a subset of patients with advanced leiomyosarcoma. We hypothesize that temozolomide is the active agent in this regimen, and should be further studied.