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Poster session 04

1285P - Risk of immune-related adverse events associated with adjuvant antiPD-1/PDL-1 in solid tumors

Date

10 Sep 2022

Session

Poster session 04

Topics

Clinical Research;  Tumour Immunology;  Immunotherapy

Tumour Site

Presenters

Cristina Serrano

Citation

Annals of Oncology (2022) 33 (suppl_7): S581-S591. 10.1016/annonc/annonc1066

Authors

C. Serrano1, R.R. Irene2, D. Jiménez Duque3, G.A. De Velasco Oria4

Author affiliations

  • 1 Oncology, Hospital Universitario 12 de Octubre, 28041 - Madrid/ES
  • 2 Medical Oncologist, Hospital Virgen de la Salud, 49004 - Toledo/ES
  • 3 Medical Oncologist, Hospital General Ciudad Real, 13005 - Ciudad Real/ES
  • 4 Medical Oncology Department, Hospital Universitario 12 de Octubre, 28041 - Madrid/ES

Resources

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Abstract 1285P

Background

Immune checkpoint inhibitors targeting PD-1/PD-L1 (IO) have deeply transformed the landscape of treatment of metastatic solid tumors and are likely to shape the adjuvant setting. Balance between safety and efficacy should be considered, especially potential serious adverse events. The aim of this systematic review was to determine the risk of developing serious immune related adverse events (irAEs) in patients treated with IO in the adjuvant setting.

Methods

We performed a systematic review of the evidence available in Pubmed of all randomized phase II-III clinical trials comparing IO versus placebo or observation in the adjuvant setting published up to March 2022. Protocol was registered in PROSPERO. Odds ratio (OR) of adverse events for all grade and high-grade were calculated.

Results

Seven studies involving 5425 patients were included (2876 patients in the IO arm and 2549 in the observation/placebo control group). 19% of patients receiving IO reported an irAE compared to 8,7% in the control arm, and 1 out of 7 patients had a high-grade irAE with IO compared to 1 out of 14 patients in the control arm. The OR in the IO group vs placebo/observation was 3,20 (95% CI, 2,41 – 4,26) in all-grade irAEs; 3,49 (95% CI, 1,82 – 6,69) in high-grade (grade 3-4) irAEs; and 4,17 (95% CI, 1,47 – 11,89) in serious AEs. There was not a statistically significant difference between the incidence of deaths due to irAEs, with an OR 3,66 (95% CI, 0,60 – 22,32).

Conclusions

Our study showed that the risk of developing irAEs is a more than three times higher risk of developing an immune-related adverse event in the group of adjuvant antiPD-1/PDL-1 compared to observation/placebo, with no differences in the incidence of deaths. This analysis provides a comprehensive overview of ICI-associated AEs in the adjuvant setting, and these findings may help and guide clinicians in management and decision-making of patients with indication of adjuvant treatment.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

Hospital 12 de Octubre.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.

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