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Abstract：
Background: Bevacizumab (BV) is widely used in routine cancer treatment and clinical therapy in combination with many other agents. This study aims to describe and analyse post-market cases of pulmonary haemorrhage and haemoptysis reported with different BV treatment regimens by mining data from the United States Food and Drug Administration Adverse Event Reporting System (FAERS) database. Methods: Data were collected from the FAERS database between 2004 Q1 and 2023 Q1. Disproportionality analysis including the reporting odds ratio (ROR) was employed to quantify the signals of disproportionate reporting of pulmonary haemorrhage and haemoptysis adverse events (AEs) associated with BV-related treatment regimens. The demographic characteristics, time to onset and outcomes were further clarified. Results: A total of 55,184 BV-associated reports were extracted from the FAERS database, of which 497 reports related to pulmonary haemorrhage and haemoptysis. Overall, the median onset time of pulmonary haemorrhage and haemoptysis AEs was 43 days (interquartile range (IQR) 15-117 days). In the subgroup analysis, BV plus targeted therapy had the longest median onset time of 90.5 days (IQR 34-178.5 days), while BV plus chemotherapy had the shortest of 40.5 days (IQR 14-90.25). BV plus chemotherapy disproportionately reported the highest percentage of death (148 deaths out of 292 cases, 50.68%). Moreover, the BV-related treatments including four subgroups in our study demonstrated the positive signals with the association of disproportionate reporting of pulmonary haemorrhage and haemoptysis. Notably, BV plus chemotherapy showed a significant higher reporting risk in pulmonary haemorrhage and haemoptysis signals of disproportionate reporting in comparison to BV monotherapy (ROR 5.35 [95% CI, 4.78-6.02] vs. ROR 4.19 [95% CI, 3.56-4.91], p = 0.0147). Conclusion: This study characterized the reporting of pulmonary haemorrhage and haemoptysis, along with the time to onset and demographic characteristics among different BV-related treatment options. It could provide valuable evidence for further studies and clinical practice of BV.
摘要：
背景:贝伐单抗(Bevacizumab,BV)广泛应用于肿瘤的常规治疗和临床治疗。本研究旨在通过挖掘美国食品和药物管理局不良事件报告系统（FAERS）数据库中的数据，描述和分析不同BV治疗方案报告的上市后肺出血和咯血病例。方法：数据收集自2004年第一季度至2023年第一季度的FAERS数据库。包括报告比值比（ROR）在内的不成比例分析用于量化与BV相关治疗方案相关的肺出血和咯血不良事件（AE）的不成比例报告信号。人口特征，进一步阐明起病时间和结局.结果：从FAERS数据库中提取了55,184份BV相关报告，其中497例报告与肺出血和咯血有关。总的来说,肺出血和咯血AE的中位发病时间为43天(四分位距(IQR)15~117天).在亚组分析中，BV加靶向治疗的最长中位发病时间为90.5天（IQR34-178.5天），而BV加化疗最短，为40.5天（IQR14-90.25）。BV加化疗不成比例地报告了最高的死亡百分比(292例病例中有148例死亡,50.68%）。此外，在我们的研究中,包括4个亚组在内的BV相关治疗显示阳性信号与肺出血和咯血的不成比例报告相关.值得注意的是,与BV单一疗法相比，BV加化疗在肺出血和咯血信号的报告风险明显更高（ROR5.35[95％CI，4.78-6.02]vs.ROR4.19[95%CI，3.56-4.91]，p=0.0147)。结论：本研究以肺出血和咯血的报告为特征，以及不同BV相关治疗方案的发病时间和人口统计学特征。为BV的进一步研究和临床实践提供了有价值的证据。
