| アブストラクト | BACKGROUND: The Phosphoinositide 3-kinases (PI3Ks) family plays a crucial role in tumorigenesis. Alpelisib (inhibiting PI3Kalpha), copanlisib (inhibiting PI3Kalpha andPI3Kdelta), duvelisib (inhibiting PI3Kdelta and PI3Kgamma), and idelalisib (inhibiting PI3Kdelta) were developed to target the PI3K pathway. However, the toxicity limits their application to some extent. It's necessary to investigate the adverse effects (AEs) of these inhibitors. RESEARCH DESIGN AND METHODS: We conducted a comparative analysis of the safety signals of AEs in PI3K inhibitors using disproportionality analysis in the FDA Adverse Event Reporting System database(FAERS). RESULTS: Our study identified significant safety signals for metabolic disorders with all PI3K inhibitors. Notable safety signals for gastrointestinal disorders were observed with most PI3K inhibitors, with the exception of copanlisib. Common AEs shared among all PI3K inhibitors included colitis and dehydration. Alpelisib displayed unique AEs associated with metabolic disorders, whereas copanlisib exhibited idiosyncratic AEs linked to cardiac and vascular disorders. Stevens-Johnson syndrome emerged as a common severe adverse event (SAE) among alpelisib, copanlisib, and idelalisib, while febrile neutropenia was prevalent among copanlisib, duvelisib, and idelalisib. Intestinal perforation was solely associated with alpelisib. CONCLUSIONS: The safety profiles of the five PI3K inhibitors vary concerning adverse events. These findings could guide drug selection and inform future prospective research. |
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| 組織名 | Diagnosis and Treatment Center of Breast Diseases, Shantou Central Hospital,;Shantou, Guangdong Province, China.;Clinical Research Center, Shantou Central Hospital, Shantou, Guangdong Province,;China.;Department of Breast Surgery, Zhujiang Hospital, Southern Medical University,;Guangzhou, Guangdong Province, China.;Department of Pharmacy, Women and Children's Hospital, School of Medicine, Xiamen;University, Xiamen, Fujian Province, China.;Department of Oncology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University,;Department of Oncology, Shenshan Medical Center, Sun Yat-sen Memorial Hospital,;Sun Yat-sen University, Shanwei, Guangdong Province, China. |
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