Weissman Simcha, Saleem Saad, Sharma Sachit, Krupka Menashe, Inayat Faisal, Aziz Muhammad, Tabibian James H
Department of Medicine, Hackensack Meridian Health Palisades Medical Center, North Bergen, NJ, USA.
Department of Medicine, Sunrise Hospital and Medical Center, Las Vegas, NV, USA.
Liver Res. 2021 Mar;5(1):28-32. doi: 10.1016/j.livres.2021.01.003. Epub 2021 Jan 23.
Anti-neoplastic immunotherapy has revolutionized cancer management; however. its safety profile with respect to liver-related injury remains largely unexplored. Herein, we analyzed a United States national database to determine the incidence, mortality, and predictors of hepatotoxicity in the setting of anti-neoplastic immunotherapy.
This was a nationwide retrospective study of hospital encounters from 2011 to 2014 using the National Inpatient Sample (NIS) database. We utilized the International Classification of Diseases, Ninth Revision (ICD-9) coding system to identify all adult patients who underwent anti-neoplastic immunotherapy during hospitalization. The primary outcome was the incidence of hepatotoxicity during the same hospitalization. Secondary outcomes included in-hospital mortality as well as socioeconomic and ethno-racial predictors of hepatotoxicity. Analyses were performed using IBM SPSS Statistics 23.0.
The sample included 3002 patients who underwent inpatient anti-neoplastic immunotherapy. The incidence of hepatotoxicity was 10.1%, which was significantly higher as compared to a matched inpatient population (adjusted odds ratio (aOR) 4.93, 95% confidence interval (CI): 3.80-6.40. 0.001). No significant mortality difference was seen in those that developed hepatotoxicity compared to those who did not (aOR 0.47. 95% CI: 0.03-8.03, 0.612). Age under 60 (aOR 1.56. 95% CI: 123-1.78, 0.050) and white race (aOR 1.85. 95% CI: 1.35-2.04, <0.010) were independent risk factors for developing immunotherapy-associated hepatotoxicity.
In this large, nationwide database analysis, we found that anti-neoplastic immunotherapy was associated with a nearly five-fold risk of in-hospital hepatotoxicity as compared to a matched inpatient population, though without an associated mortality difference. Additionally, younger age and white race were identified as predictors of immunotherapy-associated hepatotoxicity. Heightened vigilance and prospective investigation of the risk factors and liver-related adverse effects of anti-neoplastic immunotherapy are warranted.
抗肿瘤免疫疗法彻底改变了癌症治疗模式；然而，其与肝脏相关损伤的安全性概况在很大程度上仍未得到充分探索。在此，我们分析了一个美国国家数据库，以确定抗肿瘤免疫疗法背景下肝毒性的发生率、死亡率及预测因素。
这是一项利用国家住院样本（NIS）数据库对2011年至2014年医院就诊情况进行的全国性回顾性研究。我们使用国际疾病分类第九版（ICD - 9）编码系统来识别所有在住院期间接受抗肿瘤免疫疗法的成年患者。主要结局是同一住院期间肝毒性的发生率。次要结局包括院内死亡率以及肝毒性的社会经济和种族预测因素。分析使用IBM SPSS Statistics 23.0进行。
样本包括3002例接受住院抗肿瘤免疫疗法的患者。肝毒性发生率为10.1%，与匹配的住院患者群体相比显著更高（调整优势比（aOR）4.93，95%置信区间（CI）：3.80 - 6.40，P < 0.001）。与未发生肝毒性的患者相比，发生肝毒性的患者在死亡率上无显著差异（aOR 0.47，95% CI：0.03 - 8.03，P = 0.612）。60岁以下（aOR 1.56，95% CI：1.23 - 1.78，P = 0.050）和白人种族（aOR 1.85，95% CI：1.35 - 2.04，P < 0.010）是发生免疫疗法相关肝毒性的独立危险因素。
在这项大规模的全国性数据库分析中，我们发现与匹配的住院患者群体相比，抗肿瘤免疫疗法与院内肝毒性风险增加近五倍相关，尽管在死亡率上无相关差异。此外，年龄较小和白人种族被确定为免疫疗法相关肝毒性的预测因素。有必要提高警惕并对抗肿瘤免疫疗法的危险因素及肝脏相关不良反应进行前瞻性研究。
