Abstract 98P
Background
Immune-related adverse events (irAEs) are frequent and potentially affect every tissue and organ. Immune checkpoint inhibitor (ICI)-induced symptomatic myocarditis occurs only in around 1% of ICI-treated patients (pts), but is fatal in 50% of cases.
Methods
Pts undergoing ICI therapy at the Humanitas Cancer Center from May 2021 to June 2024 were prospectively recruited and assigned to three study groups: 1) ICI as monotherapy (Mono) 2) ICI in combination (Combo) 3) history of cardiac disease or at least two cardiological risk factors (Cardio). All pts underwent a complete cardiological assessment comprising clinical visit, 12-lead ECG, and multiparametric cardiac MRI (cMRI) at two time-points: prior initiation of the ICI therapy, and around 8 weeks later. cMRI scans were performed using a 1.5 Tesla scanner. Chi-square, Fisher exact and paired t-test were used to compare groups. Study objectives were detection of subclinical cardiac damage and identification of groups of patients at major risk.
Results
We present data on the first 57 pts enrolled, renal carcinoma (n=21), melanoma (n=16) and NSCLC (n=3) were the most represented tumors; 17 (30%), 20 (35%) and 20 (35%) pts were assigned to the Mono, Combo and Cardio group, respectively. Most pts (50, 88%) were treated with ICI for locally advanced/metastatic disease (34 as first-line therapy, 16 from second-line on), while 7 (12%) as adjuvant therapy. All pts received an anti-PD-1/PD-L1, either as single agent (30, 53%) or in combination, with ICI plus a TKI being the most frequent combinatorial strategy (20; 35%). Overall, the cMRI analysis showed a statistically significant left ventricle ejection fraction (LVEF) reduction pre- versus post-ICI treatment (p 0.008), with 23 (40%) pts experiencing a loss of more than 3 points of LVEF. No statistically significant differences in LVEF reduction were observed considering the three different groups (p=0.6) or occurrence of any grade non-cardiological irAEs (p=0.7).
Conclusions
Our study showed a statistically significant reduction in LVEF, with more that 3% LVEF loss in a clinically significant proportion of patients (23; 40%), not selected for cardiac history, warranting prospective evaluation to identify pts at higher risk.
Legal entity responsible for the study
The authors.
Funding
AIRC IG 24988.
Disclosure
A. Santoro: Financial Interests, Personal, Advisory Board: BMS, Servier, Gilead, Pfizer, Eisai, Bayer, MSD; Financial Interests, Personal, Speaker, Consultant, Advisor: Sanofi, Incyte; Financial Interests, Personal, Speaker’s Bureau: Takeda, BMS, Roche, Abb-Vie, Amgen, Celgene, Servier, Gilead, AstraZeneca, Pfizer, Lilly, Sandoz, Eisai, Novartis, Bayer, MSD. M. Simonelli: Financial Interests, Personal, Advisory Board: Incyte, Cytovia, Glaxo; Financial Interests, Personal, Invited Speaker: Glaxo, Bristol Myers Squibb; Financial Interests, Personal, Other, Data Monitoring Committee: Sanofi; Financial Interests, Personal, Other, Steering Committee: BMS/Celgene; Financial Interests, Personal, Other, Travel grant: Roche; Financial Interests, Personal, Other, Travel Grant: Pfizer. All other authors have declared no conflicts of interest.
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