Safety of alisertib in the treatment of solid and hematological cancers: A systematic review and meta-analysis of randomized controlled trials.

BackgroundAlisertib, an Aurora kinase A inhibitor, has been investigated as a potential treatment for various hematologic and solid tumors. While clinical trials have suggested its efficacy in both cancer types, concerns persist regarding its safety profile particularly its hematologic and gastrointestinal toxicities. This systematic review and meta-analysis evaluate the safety of alisertib in patients with hematologic cancers and solid tumors across randomized controlled trials.MethodsOnline databases were searched comprehensively for phase II and phase III randomized controlled trials (RCTs), including the use of alisertib compared with chemotherapy in the treatment of solid and hematological tumors. The primary outcomes assessed were all-grade treatment-related adverse events (TRAEs) and grade ≥3 TRAEs, while individual adverse events (AEs) were evaluated as secondary outcomes.ResultsA pooled analysis of four studies involving 765 patients showed significantly higher rates of all-grade and grade ≥3 AEs in the alisertib group compared to chemotherapy. Hematologic toxicities, including anemia, febrile neutropenia, neutropenia, and leukopenia, were markedly increased with alisertib. Similarly, gastrointestinal AEs, particularly diarrhea, were more frequent in the alisertib group.ConclusionAlisertib significantly increases the risk of hematologic and gastrointestinal toxicities compared to chemotherapy, highlighting the need for careful monitoring and a thorough benefit-risk assessment.