Safety of immune checkpoint inhibitors: An updated comprehensive disproportionality analysis and meta-analysis.

Disproportionality analysis Food and Drug Administration Adverse Event Reporting System GRADE analysis Immune Checkpoint Inhibitors Meta-analysis Open Vigil 2.1-MedDRA-v24

Journal

Critical reviews in oncology/hematology

ISSN: 1879-0461

Titre abrégé: Crit Rev Oncol Hematol

Pays: Netherlands

ID NLM: 8916049

Informations de publication

Date de publication:
27 May 2024

Historique:

received: 07 10 2023

revised: 12 03 2024

accepted: 21 05 2024

medline: 30 5 2024

pubmed: 30 5 2024

entrez: 29 5 2024

Statut: aheadofprint

Résumé

The exact safety profile of Immune checkpoint inhibitors (ICIs) is unclear so far. The aim of the current study is to analyse the safety profile of ICIs in cancer patients. The updated comprehensive disproportionality analysis of post-marketing data using the FAERS database and meta-analysis of randomized clinical trials (RCTs) was conducted. Disproportionality measures were calculated in terms of PRR associated with chi-square value and ROR with 95% confidence intervals whereas overall estimate measures with 95% CIs, publication bias and heterogeneity were calculated using RevMan 5.4. The GRADE analysis was also done to check the quality of evidence for each outcome. Various novel signals such as cholangitis, encephalitis, anuria, myelosuppression, and cachexia related to different system organ class were identified with ICIs. The sensitivity analysis results have indicated the influence of concomitant drugs on the identified signals. The meta-analysis results have shown a good safety profile of atezolizumab in non-small cell lung cancer (NSCLC) and melanoma, pembrolizumab in gastro-oesophageal cancer, urothelial cancer and head and neck squamous cell carcinoma (HNSCC), nivolumab in HNSCC as compared to the non-ICI group. The safety of ICIs is dependent on their types as well as on the types of cancer.

Sections du résumé

BACKGROUND BACKGROUND

The exact safety profile of Immune checkpoint inhibitors (ICIs) is unclear so far.

AIM OBJECTIVE

The aim of the current study is to analyse the safety profile of ICIs in cancer patients.

METHODOLOGY METHODS

The updated comprehensive disproportionality analysis of post-marketing data using the FAERS database and meta-analysis of randomized clinical trials (RCTs) was conducted. Disproportionality measures were calculated in terms of PRR associated with chi-square value and ROR with 95% confidence intervals whereas overall estimate measures with 95% CIs, publication bias and heterogeneity were calculated using RevMan 5.4. The GRADE analysis was also done to check the quality of evidence for each outcome.

RESULTS RESULTS

Various novel signals such as cholangitis, encephalitis, anuria, myelosuppression, and cachexia related to different system organ class were identified with ICIs. The sensitivity analysis results have indicated the influence of concomitant drugs on the identified signals. The meta-analysis results have shown a good safety profile of atezolizumab in non-small cell lung cancer (NSCLC) and melanoma, pembrolizumab in gastro-oesophageal cancer, urothelial cancer and head and neck squamous cell carcinoma (HNSCC), nivolumab in HNSCC as compared to the non-ICI group.

CONCLUSION CONCLUSIONS

The safety of ICIs is dependent on their types as well as on the types of cancer.

Identifiants

DOI: 10.1016/j.critrevonc.2024.104398 PMID: 38810844

pubmed: 38810844

pii: S1040-8428(24)00141-0

doi: 10.1016/j.critrevonc.2024.104398

pii:

doi:

Types de publication

Journal Article Review

Langues

eng

Sous-ensembles de citation

Pagination

104398

Informations de copyright

Déclaration de conflit d'intérêts

Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.