Risk and Incidence of Endocrine Immune-Related Adverse Effects Under Checkpoint Inhibitor Mono- or Combination Therapy in Solid Tumors: A Meta-Analysis of Randomized Controlled Trials
Pooled result · Any grade hypothyroidismResult — go to the resultRelative risk 7.81 95% CI 5.68–10.74Authors' conclusion
We showed that risk, independent from cancer type, and incidence of eirAEs are substantially increased with ICI therapy. Combination of ICIs increases risk for eirAEs, especially for hypophysitis/hypopituitarism.
Study context
- Population
- Patients with solid tumors in randomized controlled studies (RCTs) assessing endocrine immune-related adverse effects (eirAEs) under immune checkpoint inhibitor (ICI) therapy; PubMed/Medline, Embase, Cochrane Library
- Participants
- 42,886 patients69 RCTs
- Comparison
- ICI monotherapy or combination therapy vs control
- Outcome
- Risk and incidence of eirAEs of any grade and grade 3 to 5
Methodological detailsmeta-regression
- Meta-regression
Pooled result
Any grade hypothyroidism
Relative risk
7.81
95% CI 5.68–10.74
P < 0.0001
ICIvs Control
RR 7.81 (95% CI 5.68–10.74); P < 0.0001
As reported in the abstract
- Pooled incidence of any grade hypothyroidism
- 7.64% (95% CI, 6.23-9.17, P < .0001)
Further pooled results
| Outcome | RR (95% CI) | P value | |
|---|---|---|---|
| Insulin-dependent DM | 1.52 (1.07–2.18) | P = 0.02 | |
| 0.512Relative risk (log scale) |
- Insulin-dependent DM — Pooled incidence of insulin-dependent DM
- 0.087% (95% CI, 0.019-0.189, P = .0006)
Meta-regression of risk factors for eirAEs
- ICI combination (nivolumab plus ipilimumab; durvalumab plus tremelimumab) is an independent risk factor for any grade hypophysitis/hypopituitarism
- ICI agent is an independent risk factor for adrenal insufficiency
- Cancer type is not an independent risk factor for eirAEs
Original publication
Risk and Incidence of Endocrine Immune-Related Adverse Effects Under Checkpoint Inhibitor Mono- or Combination Therapy in Solid Tumors: A Meta-Analysis of Randomized Controlled Trials. J Clin Endocrinol Metab. Published 15 November 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →