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The Inconsistent and Inadequate Reporting Of Immune-Related Adverse Events in PD-1/PD-L1 Inhibitors: A Systematic Review of Randomized Controlled Clinical Trials.
- Source :
- Oncologist; Dec2021, Vol. 26 Issue 12, pe2239-e2246, 8p, 1 Diagram, 2 Charts, 3 Graphs
- Publication Year :
- 2021
-
Abstract
- Background. Immune-related adverse events (irAEs) are of great interest and importance in clinical practice, and many deficiencies and controversies have been noted in the reporting of irAEs. Herein, we aimed to evaluate the current status of irAE reporting in randomized controlled clinical trials (RCTs) of PD-1/PD-L1 inhibitors and to attempt to explain and solve the current pitfalls associated with this reporting. Materials and Methods. We conducted a systematic review across multiple databases, including PubMed, Web of Science, Embase, and the Cochrane Library. The RCTs that compared PD-1/PD-L1 inhibitors with standard treatments were included. The Harms extension of the Consolidated Standards of Reporting Trials (CONSORT) was used to evaluate the completeness of irAE reporting. Results. A total of 44 articles and 23,759 patients were included in the analysis. The terminology of the irAEs changed over time (p = .01) and was different among immune checkpoint inhibitors (ICIs) (p = .005). Twenty-two of the studies provided a definition of irAE, but only four of them concretely addressed this definition. The incidence of any grade of irAEs ranged from 16.9% to 96%, whereas grade 3-4 irAE ranged from 2% to 23%. The RCTs with combined therapy exhibited a higher incidence of grade 3-4 irAEs (p = .012). Thirty-two studies reported irAEs in the control arms, whereas seven studies reported irAEs only in the experimental arms. Respiratory, endocrine, and gastrointestinal disorders were the most commonly reported irAEs. IrAEs were generally neglected in the introduction or conclusion sections in all of the study reviews and were never subjected to subgroup analyses. Moreover, withdrawals due to severe irAEs, as well as clarifications of the irAE collection methods, were also poorly reported. RCTs using combination therapies in the experimental arms were associated with a higher reporting quality (p = .032). However, the completeness of the reporting did not improve over the last 5 years (p = .076). Conclusion. The reporting of irAEs was inadequate, and there are still inconsistencies and controversies in the reporting of irAEs. In the future, authors should be encouraged to adhere to the Harms extension of the CONSORT statement. [ABSTRACT FROM AUTHOR]
- Subjects :
- ONLINE information services
IMMUNE checkpoint inhibitors
MEDICAL information storage & retrieval systems
INFORMATION storage & retrieval systems
MEDICAL databases
SYSTEMATIC reviews
MANN Whitney U Test
FISHER exact test
T-test (Statistics)
DESCRIPTIVE statistics
CHI-squared test
MEMBRANE proteins
MEDLINE
IMMUNOTHERAPY
CHEMICAL inhibitors
Subjects
Details
- Language :
- English
- ISSN :
- 10837159
- Volume :
- 26
- Issue :
- 12
- Database :
- Complementary Index
- Journal :
- Oncologist
- Publication Type :
- Academic Journal
- Accession number :
- 154632428
- Full Text :
- https://doi.org/10.1002/onco.13940