Usefulness of thalidomide for the management of sarcomas

PICHON RIVIERE, A.; AUGUSTOVSKI, F.; ALCARAZ, A.; BARDACH, A.; COLANTONIO, L.; FERRANTE, D.; GARCIA MARTI, S.; GLUJOVSKY, D.; LOPEZ, A.; REGUEIRO, A.

Documentos de Evaluación de Tecnologías Sanitarias

IECS

Año: 2006 p. 1 - 30

1668-2793

The aim of this report was to assess the usefulness of thalidomide for the management of sarcomas.A search was carried out on the main literature databases (MEDLINE, Cochrane collaboration, DARE, LILACS, Central, NHS, NICE, EMBASE, Cancerlit), York's Center of Reviews and Dissemination (CRD), U.S Medicare and Medicaid, on the Internet's general search engines and metasearch engines (Scopus, Scirus, Tripdatabase), health technology assessment agencies and health sponsors. Systematic reviews, meta-analyses, randomized controlled clinical trials, observational studies, health technology assessments, clinical practice guidelines and coverage policies from other health systems were searched. Priority was given to systematic and narrative reviews and randomized clinical trials. Case series were also included. The U.S. Food and Drugs Administration (FDA) websites and the Argentine Society of Clinical Oncology were consulted, as well as the Argentine Society for Infectious Diseases (SADI) e-publications. Data from local sources on the use of health resources, costs and coverage in Argentina were also searched.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 sarcomaNo 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 sarcomasIn 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.At present, the cost of the drug is $190 (Argentine pesos 2006) per one hundred 100 mg pills.