弥散性血管内凝血是与 blinatumomab 治疗相关的一种被低估但却致命的不良事件:FAERS药物警戒分析。

IF 5.7 2区 医学 Q1 ONCOLOGY International Journal of Cancer Pub Date : 2024-11-13 DOI:10.1002/ijc.35235
Zhiqiang Song, Yang Wang, Dongliang Zhang, Tao Wang, Na Liu, Lei Gao, Libing Wang, Jianmin Yang
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引用次数: 0

摘要

血液学不良事件(AEs)是接受blinatumomab治疗的血液恶性肿瘤患者常见的严重毒性反应。然而,关键临床试验中的限制性选择标准可能会导致罕见但致命的毒性反应被低估。在本研究中,我们利用食品药品管理局不良事件报告系统(FAERS)系统分析了2014年10月至2023年12月期间与blinatumomab相关的血液学AEs。我们进行了比例失调分析以确定高报的AEs,报告几率比(ROR)和95%置信区间下限(ROR025)超过1的AEs被认为是显著的。此外,还使用逻辑回归模型计算了调整后的死亡率和报告的前 10 种血液学 AEs 的风险比 (RR)。在4745例blinatumomab相关病例中,418例(8.81%)涉及血液学AE。与完整数据库相比,我们发现有22例明显高报血液学AEs,其中骨髓抑制(n = 39 [9.33%],ROR025 = 8.04)、弥散性血管内凝血(DIC,n = 31 [7.42%],ROR025 = 15.14)和骨髓衰竭(n = 14 [3.35%],ROR025 = 3.41)在临床试验中被明显低估。DIC导致的死亡率高达45.16%。最后,在多变量逻辑回归分析中发现,DIC 与死亡有独立关联(RR = 2.47 [95% CI:1.11-3.83])。这些发现有助于临床医生及早发现这些罕见但致命的血液学 AE,从而降低 blinatumomab 受试者发生严重毒性反应的风险。
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Disseminated intravascular coagulation is an underestimated but fatal adverse event associated with blinatumomab therapy: A pharmacovigilance analysis of FAERS.

Hematologic adverse events (AEs) are common and serious toxicities in patients with hematologic malignancies undergoing blinatumomab therapy. However, restrictive selection criteria in pivotal clinical trials can lead to an underestimation of rare but fatal toxicities. In this study, we systematically analyzed hematologic AEs associated with blinatumomab using the Food and Drug Administration Adverse Event Reporting System (FAERS) from October 2014 to December 2023. Disproportionate analysis was performed to identify overreported AEs, with a reporting odds ratio (ROR), and a lower bound of the 95% confidence interval (ROR025) exceeding one considered significant. Additionally, adjusted mortality rates and risk ratios (RR) of the top 10 reported hematologic AEs were calculated using a logistic regression model. Among 4745 blinatumomab-related cases, 418 (8.81%) involved hematologic AEs. We identified 22 significantly overreporting hematologic AEs compared to the full database, with myelosuppression (n = 39 [9.33%], ROR025 = 8.04), disseminated intravascular coagulation (DIC, n = 31 [7.42%], ROR025 = 15.14), and bone marrow failure (n = 14 [3.35%], ROR025 = 3.41) notably underestimated in clinical trials. DIC resulted in a substantial mortality rate of 45.16%. Finally, DIC was found to be independently associated with death in a multivariable logistic regression analysis (RR = 2.47 [95% CI: 1.11-3.83]). These findings could aid clinicians in the early detection of these rarely reported but fatal hematologic AEs, thereby reducing the risk of severe toxicities in blinatumomab recipients.

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来源期刊
CiteScore
13.40
自引率
3.10%
发文量
460
审稿时长
2 months
期刊介绍: The International Journal of Cancer (IJC) is the official journal of the Union for International Cancer Control—UICC; it appears twice a month. IJC invites submission of manuscripts under a broad scope of topics relevant to experimental and clinical cancer research and publishes original Research Articles and Short Reports under the following categories: -Cancer Epidemiology- Cancer Genetics and Epigenetics- Infectious Causes of Cancer- Innovative Tools and Methods- Molecular Cancer Biology- Tumor Immunology and Microenvironment- Tumor Markers and Signatures- Cancer Therapy and Prevention
期刊最新文献
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