112P - Close cardiovascular monitoring during the early stages of treatment for patients receiving immune checkpoint inhibitors

Background

Immune checkpoint inhibitors (ICIs) can lead to a wide range of cardiovascular (CV) adverse events. As the population of cancer patients receiving ICIs is rapidly growing, there is a high need for both short- and long- term monitoring tools to promptly detect these side effects. Therefore, we developed a prospective, multicenter trial (NCT05699915) in which we assess different cardiac biomarkers as well as routine three dimensional (3D) echocardiography in cancer patients with a solid tumor treated with ICIs.

Methods

All patients underwent routine investigations of blood parameters (high-sensitivity troponin I and T (hs-TnI and hs-TnT), N-terminal pro-brain natriuretic peptide levels (NT-proBNP), in particular) and a thorough CV follow-up (electrocardiography and echocardiography) at fixed time points. The primary endpoint was defined as the incidence of an elevated hs-TnT above the upper limit of normal (ULN) if the baseline value was normal; or 1.5 ≥ times baseline if the baseline value was above the ULN, during the first three months of treatment. Here, we present the results of a preliminary analysis of the first cohort of 59 patients after three months of follow-up.

Results

The mean patient age was 68 ± 12 years; 76% were men. 56% of the patients received an anti-PD-1 agent, while 19% received anti-PD-L1. Overall, 25% of patients received combination therapy. Troponin elevation, as defined in the primary endpoint, occurred in 10.6% [95% CI: 5.0-22.5]. No patients, however, experienced a clinically significant CV event. Furthermore, there were no changes in 3D left ventricular (LV) ejection fraction or LV global longitudinal strain following three months of ICI treatment (55.95 ± 5.95% vs. 56.05 ± 6.46%, p = 0.903 and -17.8% [-18.5 ; -14.2] vs. -17.0% [-18.8 ; -15.1], p = 0.663). No significant changes in diastolic function or right ventricular function were found either. In addition, there was poor agreement between hs-TnT and hs-TnI.

Conclusions

Our preliminary findings found hs-TnT elevation in 10% of cancer patients during the first three months of ICI therapy. However, no significant changes were noted on 3D echocardiography at three months. Hence, longer follow-up and further research are needed.

Clinical trial identification

NCT05699915.

Legal entity responsible for the study

University of Antwerp.

Funding

Has not received any funding.

Disclosure

C. Vulsteke: Financial Interests, Personal, Advisory Board: MSD, Janssen-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. N. Van de Veire: Financial Interests, Personal, Advisory Role: Pfizer; Financial Interests, Personal, Speaker’s Bureau: Pfizer, Menarini, Daiichi Sankyo Pharmaceutical; Financial Interests, Personal, Other, Travel, Accomodations, Expenses: Boehringher Ingelheim. D. Vervloet: Financial Interests, Personal, Advisory Role: Novartis, Pfizer, AstraZeneca Co.; Financial Interests, Personal, Speaker’s Bureau: Novartis, Pfizer, Izidok, AstraZeneca Co.; Financial Interests, Personal, Other, Travel, Accomodations, Expenses: Pfizer, Novartis. V. Moerman: Financial Interests, Personal, Other, Honoraria: Menarini; Financial Interests, Personal, Other, Travel, Accomodations, Expenses: Menarini, Daiichi Sankyo Pharmaceutical, Bayer US, LLC. L. van Calster: Financial Interests, Personal, Other, Employment: Maatschap Cardiologie. M. Peeters: Financial Interests, Personal, Advisory Role: Amgen, Bayer, Ipsen, Remedus, Sanofi, Sirtex Medical, Terumo, Merck, MSD, Qurin; Financial Interests, Personal, Leadership Role: Qurin; Financial Interests, Personal, Speaker’s Bureau: Amgen, Bayer US, Llc, Merck Serono, Roche, Sanofi, Servier, Sirtex Medical; Financial Interests, Personal, Stocks or ownership: BIMINI BioTech; Financial Interests, Personal, Other, Honoraria: Amgen, Bayer US, Llc, Sanofi, Servier, Merck, Bristol Myers Squibb, MSD, Roche, Sirtex Medical; Financial Interests, Personal, Funding: Amgen, Bayer US, Llc, Ipsen, Novartis, Roche. 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. All other authors have declared no conflicts of interest.