Authors' objectives:

The aim of this report was to assess the usefulness of thalidomide for the management of sarcomas.

Authors' results and conclusions: Priority was given to controlled clinical trials and reviews of the proposed subjects. For this report, eight narrative reviews, three case series and four case reports were used. No health technology assessment, controlled randomized clinical trials, clinical practice guidelines or systematic reviews were identified. Kaposi sarcoma No controlled clinical trials were found. Three case series, which included a total of 50 patients, were detected. Little et al. studied the drug in a Phase II non-controlled study with escalating doses from 200 to 1000 mg/d (depending on tolerance) jointly administered with antiretroviral therapy, for one year, in patients with severe disease. Out of the 17 patients who were considered evaluable, eight achieved partial responses which lasted a median time of 8 months after two months of treatment. The mean dose used was 500 mg/d; 5 out of 20 patients discontinued treatment due to toxicity (depression, fever, exanthema, and neurological toxicity). Advanced gynecologic sarcomas In 2006, Yi-Shin Kuo published a series in which 17 patients with sarcoma or metastatic gynecologic carcinosarcoma were enrolled after surgical treatment, radiotherapy and/or chemotherapy; no therapeutic benefits were seen. As regards other types of sarcomas, only case reports were found. Adverse effects: In addition to the already known teratogenic effects, this drug can cause deep vein thrombosis, constipation, fatigue, dizziness, insomnia and cutaneous exanthema.

Authors' recommendations: The evidence is based on few case series which enrolled few patients. Although this drug has shown promising results at inducing temporary partial responses in up to 35% of patients treated for Kaposi's Sarcoma, the populations studied are heterogeneous, present severe forms and there is no comparative group for analysis. Its effectiveness regarding overall survival and disease free survival remains unknown. At present, the treatment of choice still is antiretroviral therapy (HAART), and chemotherapy with vinca alkaloids, liposomal anthracyclines or paclitaxel for the more aggressive forms. Controlled studies are clearly needed to determine the drug effectiveness for sarcoma. In spite of the lack of evidence, it could be considered as a last resource treatment for patients with severe visceral involvement and poor response to standard treatment. Its assessment in other types of sarcoma is anecdotal.

Authors' methods: Overview

Project Status: Completed

URL for project: http://www.iecs.org.ar/

Year Published: 2006

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Argentina

Organisation Name: Institute for Clinical Effectiveness and Health Policy

Contact Address: Dr. Emilio Ravignani 2024, Buenos Aires - Argentina, C1414 CABA

Contact Name: info@iecs.org.ar

Contact Email: info@iecs.org.ar

Copyright: Institute for Clinical Effectiveness and Health Policy (IECS)