1048P - Cardiovascular toxicities in cancer patients treated with immune checkpoint inhibitors: Evidence from a Belgian real-world multicenter study

Background

Immune checkpoint inhibitors (ICIs) are increasingly being used among a wide range of cancer types, in combination with other anti-cancer therapies and in many different treatment settings. ICIs can give rise to adverse events (AE), of which cardiovascular (CV) AEs are relatively uncommon though can be potentially fatal. Therefore, we aimed to describe the occurrence of CV AEs in a real-world cohort of Belgian cancer patients.

Methods

Patient data (structured and unstructured) from three Belgian hospitals were collected into an Observational Medical Outcomes Partnership Common Data Model (OMOP CDM) data warehouse using a natural language processing (NLP) algorithm. The observational study includes patients receiving at least one ICI cycle (PD-1, PD-L1 and/or CTLA-4) between March 2017 and August 2022. We analyzed CV events occurring from the first ICI administration until the end of follow-up (or death). The first occurrence of a CV event, that was absent before treatment, was identified and validated at patient level, without differentiating between immune-related and other CV AEs.

Results

Of 1574 patients with a diagnosis of malignancy, the median age was 67 ± 11.3 years with the majority of patients being male (66%). CV AEs occurred in 197 patients (12.5%). The following CV AE diagnoses were detected: heart failure (5.3%), atrial fibrillation (4.6%), myocardial infarction (2.0%), conduction abnormalities (1.9%), myocarditis (1.2%), vasculitis (0.8%), and pericarditis (0.4%). The median time of onset (in days) was 109 (17 - 849) for myocarditis, 141 (1 - 1350) for heart failure, 152 (7 - 1650) for atrial fibrillation, 174 (7 - 1030) for vasculitis, 210 (12 - 1410) for myocardial infarction, 243 (83 - 1200) for pericarditis, 283 (2 - 1570) for conduction abnormalities, and 326 (71 - 970) days for cardiomyopathy.

Conclusions

Using our NLP approach, we can report real-world occurrence and timelines of CV AE onset during and after ICI treatment, which might have been underestimated in RCTs due to strict inclusion criteria and limited reporting of the full range of AEs in pharmacovigilance databases. Ongoing analyses will shed further insights on patient characteristics and potential risk factors of CV AEs.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

LynxCare.

Funding

LynxCare.

Disclosure

C.L. Oeste, I. Bassez: Other, Personal, Employment: LynxCare. A.T.L. Verbiest: Financial Interests, Institutional, Invited Speaker: Novartis, Ipsen; Financial Interests, Institutional, Advisory Board: Ipsen; Non-Financial Interests, Principal Investigator, PI of an investigator-initiated multicenter study on real-world outcomes in immuno-oncology, by buiding research-grade clinical data warehouses in collaboration with Lynxcare. D.F.E. Hens: Other, Personal, Management: LynxCare. P.R. Debruyne: Financial Interests, Institutional, Research Grant: Pfizer; Financial Interests, Personal, Advisory Role: Astellas Pharma, BMS, Ipsen, Merck, Pfizer. H. Prenen: Financial Interests, Institutional, Advisory Board: Amgen, Roche, AstraZeneca; Financial Interests, Institutional, Invited Speaker: Bayer, Ipsen, Sanofi. J. De Sutter: Financial Interests, Personal, Advisory Role: Novartis, Bayer US, Llc. C. Vulsteke: Financial Interests, Personal, Advisory Board: MSD, Janssens-Cilag, GSK, Astellas Pharma, BMS, Leo Pharma, Bayer, AstraZeneca, Pfizer, Merck; Financial Interests, Institutional, Research Grant, Funding for research project on immune related toxicities: MSD. All other authors have declared no conflicts of interest.