期刊
FRONTIERS IN ONCOLOGY
卷 11, 期 -, 页码 -出版社
FRONTIERS MEDIA SA
DOI: 10.3389/fonc.2021.662392
关键词
PD-1; PD-L1 inhibitors; cancer; meta-analysis; safety assessment; clinical trial
类别
资金
- Academic Promotion Program of Shandong First Medical University [2019QL025]
- Natural Science Foundation of Shandong Province [ZR2019MH042]
- Jinan Science and Technology Program [201805064]
- Postdoctoral Innovation Project of Jinan
PD-1/PD-L1 inhibitors have a lower risk of death compared to chemotherapy in clinical trials. In addition to death, they also have better safety profiles when considering treatment-related adverse events, discontinuation of therapy, and grades 3-5 adverse events.
Background Understanding the safety and adverse event profiles of PD-1/PD-L1 inhibitors is important in guiding cancer immunotherapy. Consequently, we designed this meta-analysis to evaluate the safety of PD-1/PD-L1 inhibitors in clinical trials involving cancer patients. Methods Four safety indicators comprising treatment-related adverse events, death, discontinuation of therapy and grades 3-5 adverse events were evaluated using the random effect model. The quality of enrolled trials was assessed using the Newcastle Ottawa Scale (NOS). Results Forty-four clinical trials were included in the final meta-analysis. Compared with chemotherapy, the risk of death due to the use of PD-1/PD-L1 inhibitors was much lower than that experienced in the control group (OR = 0.65, 95%CI: [0.47, 0.91], I-2 = 0%, Z = 2.52 (P = 0.01)). Similar observations were apparent regarding the other three indicators of safety and also when the use of PD-1/PD-L1 inhibitors alone is compared with the combined use of PD-1/PD-L1 and CTLA-4. When used together with chemotherapy, PD-1/PD-L1 inhibitors increased the incidence of the adverse events as compared to the use of chemotherapy alone. Increased risks for adverse events were also noticed with the use of PD-1/PD-L1 inhibitors over the use of a placebo. Conclusion The use of PD-1/PD-L1 inhibitors alone is associated with a better safety profile compared to either the use of chemotherapy or the use of PD-1/PD-L1 inhibitors with other anticancer regimens.
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