Efficacy and safety of thalidomide for oncology-related uses approved in Brazil: An overview of systematic reviews.

Objective: The aim of this overview was to summarize evidence of the efficacy and safety of thalidomide in the treatment of oncology-related diseases approved in Brazil, and to assess the quality of the available data. Methods: A literature search was performed in the Cochrane Library, PubMed, Embase, Lilacs, and SciELO databases. Studies must contain evidence of efficacy and/or safety of thalidomide use for multiple myeloma - MM, graft-versus-host disease - GVHD, and myelodysplastic syndrome - MDS. The extracted information were: authors, year, literature search, studies design, target population, studies sample, comparisons and thalidomide dose, funding, outcomes, results / pooled effect, heterogeneity, conclusion. Results: This overview showed the available data about efficacy and safety of thalidomide used in the treatment of oncology-related approved indications in Brazil. It also classified the methodological quality of studies according to Amstar 2 tool. Despite of the poor quality of the articles found, they supported the efficacy of thalidomide in MM treatment. The main adverse events reported were peripheral neuropathy, infections, hematological, thromboembolic, and gastrointestinal events. Evidence supported that the more drugs combined, the greater the efficacy, but there is also a greater risk of toxicity. For the indications of GVHD and MDS no systematic reviews and/or meta-analyses that met the inclusion criteria were found. Conclusions: The overview confirmed thalidomide's efficacy on MM. It is important to monitor and manage the occurrence of thalidomide-related adverse events. Strict control over its use must always be reinforced to maintain its safe use.