| アブストラクト | OBJECTIVE/BACKGROUND: We aimed to evaluate the risk of PARP inhibitors (PARPis) causing pneumonitis in randomized controlled trials (RCTs) and in the real-world practice. METHODS: First, a systematic review based on meta-analysis was conducted. RCTs with available data reporting pneumonitis events for PARPis were eligible for analysis. Second, we conducted a disproportionality analysis based on data from the FDA Adverse Event Reporting System (FAERS) database to characterize the main features of PARPi-related pneumonitis. RESULTS: 16 trials with 5771 patients were included in our meta-analysis. Compared with control arms, PARPis showed a significant increase in the risk of pneumonitis events (Peto OR 2.68 [95% CI 1.31-5.47], p = 0.007) with no heterogeneity (I(2) = 0%, chi(2)p = 0.70). The incidence of pneumonitis across treatment arms was 0.79% (28/3551). In the FAERS database, we identified 84 cases of PARPi-pneumonitis with a fatality rate of 16% (13/79). The median time to event onset was 81 (interquartile range [IQR] 27-131) days and 87% of the adverse events occurred within 6 months. CONCLUSION: PARPis increased the risk of pneumonitis that can result in serious outcomes and tend to occur early. Early recognition and management of PARPi-pneumonitis is of vital importance in clinical practice. The mechanisms and risk factors should be studied further to improve clinical understanding and innovative treatment strategies for these diseases. |
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| 投稿者 | Ma, Zhuo; Sun, Ximu; Zhao, Zhixia; Lu, Wenchao; Guo, Qixiang; Wang, Shihao; You, Jiwen; Zhang, Yuhui; Liu, Lihong |
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| 組織名 | Department of Pharmacy, Beijing Chao-Yang Hospital, Capital Medical University, 8;Gongren Tiyuchang Nanlu, Chaoyang District, Beijing, China.;Department of Pharmacy, Beijing Obstetrics and Gynecology Hospital, Capital;Medical University, No.17, Qi He Lou Street, Dongcheng District, Beijing, China.;AI Research Division, A.I. Phoenix Technology Co., Ltd, RM1080, LV 10, CENTRAL;BLD, 1-3 PEDDER ST, CENTRAL, Hong Kong, China.;Department of Respiratory and Critical Care Medicine, Beijing Chao-Yang Hospital,;Capital Medical University, Beijing Institute of Respiratory Medicine, 8 Gongren;Tiyuchang Nanlu, Chaoyang District, Beijing, China. Electronic address:;zhangyhcy@ccmu.edu.com.;Gongren Tiyuchang Nanlu, Chaoyang District, Beijing, China. Electronic address:;liulihong@bjcyh.com. |
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