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e-Poster Display Session

41P - Cardiotoxicity of immune checkpoint inhibitors: A meta-analysis of randomized clinical trials


09 Dec 2020


e-Poster Display Session


Immunotherapy;  Supportive Care and Symptom Management

Tumour Site


Elisa Agostinetto


Annals of Oncology (2020) 31 (suppl_7): S1428-S1440. 10.1016/annonc/annonc391


E. Agostinetto1, D. Eiger1, M. Lambertini2, M. Ceppi2, M. Bruzzone2

Author affiliations

  • 1 Institut Jules Bordet, Brussels/BE
  • 2 IRCCS Ospedale Policlinico San Martino, Genova/IT

Abstract 41P


Immune-checkpoint inhibitors (ICI) can cause potentially life-threatening adverse events (AE). However, their risk of cardiotoxicity has been poorly investigated. It is also unknown whether ICI combinations increases cardiotoxicity compared to single ICI. We aimed to assess the cardiotoxicity of ICI compared to other cancer treatments (primary objective) and of dual-agent ICI (immunotherapy combinations) compared to single-agent ICI (secondary objective).


This systematic review and meta-analysis (M-A) was conducted according to the PRISMA guidelines and was registered in the PROSPERO database with the ID number CRD42020183524. A systematic search of PubMed, MEDLINE, Embase databases, and conference proceedings was performed up to June 30, 2020. All randomized clinical trials comparing ICI vs other treatments (primary objective) or dual-agent ICI vs single-agent ICI (secondary objective) in all solid tumors were included. Pooled risk ratios (RR) with 95% confidence intervals (95% CI) for cardiotoxicity events were calculated using random effect models. Two distinct M-A were performed to address the primary and secondary objectives.


Eighty studies including 35,337 patients (pts) were included in the analysis (66 studies with 34,664 pts for primary objective and 14 studies with 673 pts for secondary objective). No statistically significant differences in terms of cardiac AE were observed between the ICI and non-ICI groups nor between the dual-ICI and single-ICI groups. The table reports on pooled incidence of cardiac AE and relative RR with 95% CI. No statistically significant differences were observed in the subgroup analyses according to tumor type, setting of disease, treatment line and type of treatment. Table: 41P

Incidence of cardiac AE

ICI-group (%) Non-ICI group (%) RR (95% CI) Dual-ICI group (%) Single-ICI group (%) RR (95% CI)
Any cardiac AE 3.78 3.40 1.14 (0.88-1.48) 2.87 0.40 1.91 (0.52-7.01)
Myocarditis 0.12 0.01 1.11 (0.64-1.92) 0.17 0 1.10 (0.31-3.87)
Myocardial infarction 0.41 0.27 1.19 (0.63-2.23) 0.50 0 0.98 (0.21-4.47)
Pericarditis 0.51 0.22 1.14 (0.62-2.10) 0 0.49 0.67 (0.16-2.76)
Arrhytmias 1.79 1.49 1.32 (0.94-1.84) 2.48 0 1.65 (0.40-6.89)
Heart failure 0.43 0.63 0.61 (0.35-1.07) 0.38 0 1.04 (0.25-4.26)
Valvular disease 0 0.03 0.63 (0.24-1.64) 0 0 0.79 (0.16-3.83)
Cardiac arrest 0.24 0.09 1.23 (0.61-2.47) 0 0 0.79 (0.16-3.83)
Cardiac death 0.33 0.21 1.07 (0.72-1.59) 0.27 0 1.28 (0.48-3.42)


Use of ICI as single or combination regimens is not associated with increased risk of cardiotoxicity.

Legal entity responsible for the study

The authors.


Has not received any funding.


D. Eiger: Research grant/Funding (self), Funding for his ESMO fellowship (2018-2019): Novartis: Novartis. M. Lambertini: Honoraria (self), Advisory/Consultancy: Roche; Honoraria (self), Advisory/Consultancy: Novartis; Honoraria (self): Theramex; Honoraria (self): Takeda; Honoraria (self): Lilly; Honoraria (self): Pfizer. N.F. Pondé: Honoraria (self), Advisory/Consultancy: Lilly; Honoraria (self): Roche; Honoraria (self): Novartis; Honoraria (self): AstraZeneca. A.H. Awada: Honoraria (institution), Speaker Bureau/Expert testimony: Roche; Honoraria (institution), Speaker Bureau/Expert testimony: Lilly; Honoraria (institution), Speaker Bureau/Expert testimony: Amgen; Honoraria (institution), Speaker Bureau/Expert testimony: EISAI; Honoraria (institution), Speaker Bureau/Expert testimony: BMS; Honoraria (institution), Speaker Bureau/Expert testimony: Pfizer; Honoraria (institution), Speaker Bureau/Expert testimony: Novartis; Honoraria (institution), Speaker Bureau/Expert testimony: MSD; Honoraria (institution), Speaker Bureau/Expert testimony: Genomic Health; Honoraria (institution), Speaker Bureau/Expert testimony: Ipsen; Honoraria (institution), Speaker Bureau/Expert testimony: AstraZeneca; Honoraria (institution), Speaker Bureau/Expert testimony: Bayer; Honoraria (institution), Speaker Bureau/Expert testimony: Leo Pharma. M. Piccart: Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Board Member (Scientific Board): Oncolytics; Honoraria (institution), Speaker Bureau/Expert testimony, Board Member (Scientific Board): Radius; Honoraria (self), Honoraria (institution), Advisory/Consultancy: AstraZeneca; Honoraria (self), Advisory/Consultancy: Camel-IDS; Honoraria (self), Advisory/Consultancy: Crescendo Biologics; Honoraria (self), Advisory/Consultancy: Debiopharm; Honoraria (self), Advisory/Consultancy: G1 Therapeutics; Honoraria (self), Honoraria (institution), Advisory/Consultancy: Genentech; Honoraria (self), Advisory/Consultancy: Huya; Honoraria (self), Advisory/Consultancy: Immunomedics; Honoraria (self), Honoraria (institution), Advisory/Consultancy: Lilly; Honoraria (self), Advisory/Consultancy: Menarini; Honoraria (self), Honoraria (institution), Advisory/Consultancy: MSD; Honoraria (self), Honoraria (institution), Advisory/Consultancy: Novartis; Honoraria (self), Advisory/Consultancy: Odonate; Honoraria (self), Advisory/Consultancy: Periphagen; Honoraria (self), Honoraria (institution), Advisory/Consultancy: Pfizer; Honoraria (self), Honoraria (institution), Advisory/Consultancy: Roche; Honoraria (self), Advisory/Consultancy: Seattle Genetics; Honoraria (institution): Servier. E. de Azambuja: Honoraria (self), Honoraria (institution), Advisory/Consultancy, Travel/Accommodation/Expenses: Roche/GNE; Honoraria (self), Honoraria (institution), Advisory/Consultancy, Travel/Accommodation/Expenses: Novartis; Honoraria (self), Advisory/Consultancy: Seattle Genetics; Travel/Accommodation/Expenses: GSK; Honoraria (institution): AstraZeneca; Honoraria (institution): Servier. All other authors have declared no conflicts of interest.

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