Nivolumab-associated pulmonary toxicities： a retrospective study based on FARES database from 2016 to 2019
10.19428/j.cnki.sjpm.2021.20630
- VernacularTitle:免疫抑制剂纳武单抗的呼吸系统药物毒性：基于2016—2019年FARES数据库的回顾性研究
- Author:
Fang-yuan HU
1
;
Ying-hong ZHAI
2
;
Jin-fang XU
1
;
Xiao-jing GUO
1
;
Zhi-jian GUO
1
;
Xiang ZHOU
2
;
Yi ZHENG
1
;
Li-jie CHI
1
;
Xiao-fei YE
1
;
Jia HE
1
Author Information
1. Department of Medical Statistics， Faculty of Medical Services， Naval Medical University， Shanghai 200433， China
2. School of Medicine， Tongji University， Shanghai 200092， China
- Publication Type:Research Article
- Keywords:
immune checkpoint inhibitors;
Nivolumab;
pulmonary toxicities;
disproportionality analysis;
FAERS database
- From:
Shanghai Journal of Preventive Medicine
2021;33(4):319-326
- CountryChina
- Language:Chinese
-
Abstract:
Objective:Nivolumab is one of the most common programmed death 1 （PD-1） inhibitors used as an immune checkpoint inhibitor （ICI）. It brings significant therapeutic effects but often accompanied by serious drug toxicity. The pulmonary toxicities of nivolumab are not clear. This study aims to systematically explore the nivolumab-associated pulmonary toxicities and provide reference for clinical treatment. Methods:Data were extracted from US Food and Drug Administration （FDA） Adverse Event Reporting System （FAERS） database from January 1， 2016 to September 30， 2019. Two types of disproportionality analysis， information component （IC） and reporting odds ratio （ROR）， were applied in nivolumab-associated pulmonary adverse events （AEs） signal detection. Results:A total of 28 489 309 records were extracted from FAERS database and 8 181 records were associated with nivolumab. Analysis was conducted in 179 AEs and 86 signals were detected. Notably， potent signals were detected in radiation pneumonitis （IC025： 3.99， ROR025： 17.25）， pneumonitis （IC025： 3.34， ROR025： 10.64） and bronchial fistula （IC025： 2.94， ROR025： 8.78）. Nivolumab-associated pulmonary toxicities were more frequently reported in dyspnoea （IC025： 0.50， ROR025： 1.44）， pneumonia （IC025： 0.08， ROR025： 1.07） and pneumonitis （IC025： 3.34， ROR025： 10.64）. Results of IC and ROR methods were similar to each other. Most pulmonary toxicities were observed in patients with non-small cell lung cancer （N=3 711， 32.13%）， malignant melanoma （N=1 658， 14.36%） and renal cell carcinoma （N=731， 6.33%）. Conclusion:Significant pulmonary toxicities were detected in patients treated with nivolumab. Thus， it is highly important for clinicians to be vigilant about nivolumab-associated pulmonary AEs and be prepared to take immediate action for patient safety.
