Phase II study of temozolomide and thalidomide in patients with unresectable or metastatic leiomyosarcoma Journal Article
| Authors: | Taub, R. N.; Boyar, M. S.; Hesdorffer, M.; Keohan, M. L.; Jin, Z. |
| Article Title: | Phase II study of temozolomide and thalidomide in patients with unresectable or metastatic leiomyosarcoma |
| Abstract: | 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/ m 2 /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. Copyright © 2008 Michelle S. Boyar et al. |
| Keywords: | clinical article; controlled study; treatment response; aged; overall survival; thalidomide; clinical trial; constipation; fatigue; neutropenia; drug dose reduction; drug efficacy; drug withdrawal; treatment duration; unspecified side effect; temozolomide; neurotoxicity; anorexia; edema; infection; multiple cycle treatment; phase 2 clinical trial; anemia; neuropathy; thrombocytopenia; drug fatality; nausea and vomiting; leiomyosarcoma; ataxia; visual impairment |
| Journal Title: | Sarcoma |
| Volume: | 2008 |
| ISSN: | 1357-714X |
| Publisher: | Hindawi Publishing Corporation |
| Date Published: | 2008-01-01 |
| Start Page: | 412503 |
| Language: | English |
| DOI: | 10.1155/2008/412503 |
| PROVIDER: | scopus |
| PMCID: | PMC2583339 |
| PUBMED: | 19043564 |
| DOI/URL: | |
| Notes: | --- - "Cited By (since 1996): 6" - "Export Date: 17 November 2011" - "CODEN: SARCF" - "Source: Scopus" |
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