Analysis on occurrence of adverse reactions to sintilimab in patients with non-small cell lung cancer and Hodgkin lymphoma
10.3760/cma.j.cn114015-20210508-00539
- VernacularTitle:非小细胞肺癌和霍奇金淋巴瘤患者信迪利单抗不良反应发生情况分析
- Author:
Wenjing REN
1
;
Wanlu ZHANG
1
;
Guiying FU
1
Author Information
1. 中国人民解放军总医院医疗保障中心药剂科，北京 100071
- Publication Type:Journal Article
- Keywords:
Immunosuppressive agents;
Drug-related side effects and adverse reactions;
Safety;
Sintilimab
- From:
Adverse Drug Reactions Journal
2021;23(12):624-632
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To explore the adverse reactions to sintilimab in patients with non-small cell lung cancer (NSCLC) and Hodgkin lymphoma (HL).Methods:The clinical data of all NSCLC and HL patients who were treated with sintilimab during hospitalization in the Fifth Medical Center of the PLA General Hospital from January 2019 to August 2020 were collected by searching Hospital Information System. The clinical data including patients′ basic information (gender, age, diagnosis), medication (initial treatment or retreatment with sintilimab, single and cumulative dose, combined medication), and occurrence of adverse reactions (involved organs or systems, clinical manifestations, occurrence time, intervention and outcome) were recorded and analyzed retrospectively. The correlation between sintilimab and adverse reactions and the grade of adverse reactions were evaluated according to Hand Book of Adverse Drug Reaction Reporting and Monitoring in China and the International Adverse Reaction Evaluation System of Cancer Chemotherapy Drugs.Results:A total of 90 patients were enrolled in the analysis, including 75 NSCLC patients and 15 HL patients, aged from 16 to 81 years with the median age of 63 years; 81 patients were initially treated with sintilimab and 9 were retreated. Eighty-eight patients received sintilimab 200 mg per cycle and 2 patient received 100 mg per cycle. The cumulative dose was 200, >200-1 000, and >1 000 mg in 39, 35, and 16 cases, respectively; 32 patients were treated with sintilimab alone and 58 were treated with sintilimab combined with other regimens. Fifty-three (58.9%) patients had adverse reactions, among which, 41 (45.6%) and 12 cases (13.3%) had grade 1-2 and ≥ grade 3 adverse reactions, respectively. The occurrence time was 1-242 days after treatment. Among the 53 patients, 37 were male and 16 were female, aged 28-80 years; 48 were with NSCLC and 5 with HL. The incidence of adverse reactions in NSCLC patients was significantly higher than that in HL patients [64.0% (48/75) vs. 33.3% (5/15), χ2=4.856, P=0.028]. Forty-eight patients were initially treated and 5 were retreated. Fifty-two patients received sintilimab 200 mg per cycle and 1 patient received 100 mg per cycle. The cumulative dose was 200, >200-1 000, and >1000 mg in 16, 26, and 11 cases, respectively. The difference in the incidences of adverse reactions among patients with different cumulative doses was significant ( χ2=9.21, P=0.01). Fourteen patients were treated with sintilimab alone and 39 patients were treated with sintilimab combined with other therapeutic regimens; the incidence of adverse reactions in patients with sintilimab combined with other therapeutic regimens was higher than that in patients with sintilimab monotherapy, and the difference was statistically significant [66.1% (39/58) vs. 43.8% (14/32), χ2=4.701, P=0.03]. A total of 101 times of adverse reactions to sintilimab occurred in 53 patients (1, 2, 3, 4 and 5 kinds of adverse reactions occurred in 24, 16, 9, 2, and 2 patients, respectively), 52 times of them were recorded in the medical records, and 49 times were found by rechecking the results of laboratory and auxiliary tests; 1, 3, and 97 times of adverse reactions were evaluated as "certainly", "probably", and "possibly", respectively. Eighty-nine times (88.1%) of adverse reactions were grade 1-2 and 12 times (11.9%) were equal to or greater than grade 3. Multiple systems or organs were involved in the adverse reactions including blood, hepatobiliary, gastrointestinal, endocrine, respiratory, skin and appendix, heart, skeletal muscle and connective tissue, urinary, and nervous systems, and those with the top 5 incidence rates were blood, hepatobiliary, gastrointestinal, endocrine, and respiratory system adverse reactions[24.4% (22/90), 15.6% (14/90), 14.4% (13/90), 12.2% (11/90), and 11.1% (10/90)]. Twelve patients stopped sintilimab due to adverse reactions, 4 were only closely monitored without special treatment, and 49 received one day to seven months of symptomatic treatments. Among the 53 patients, 8 were cured, 29 were improved, 6 were not improved, 9 were unknown, and 1 died. Conclusions:Sintilimab could lead to adverse reactions in multiple systems or organs in patients with NSCLC and HL, such as blood, hepatobiliary, gastrointestinal, endocrine, respiratory, and skin and appendages. The incidence and grade of adverse reactions were lower than those documented in the drug label, and no new adverse reactions were detected.
