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e24014 Background: Since Immune checkpoint inhibitor (ICI) immunotherapy has emerged as a cornerstone of modern oncology, oncologists are facing a new spectrum of ‘immune-related adverse events’ (irAEs), potentially affecting every tissue and organ. 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 December 2023 were prospectively recruited and assigned to three study groups: 1) ICI given as monotherapy (Mono) 2) ICI given in combination (Combo) 3) history of cardiac disease or two cardiological risk factors other than smoke (Cardio). Exclusion criteria were: previous exposure to any immunotherapy, combination with other cardiotoxic therapies, and acute (in the last 3 months) cardiac events. All pts underwent a complete cardiological assessment with 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. Peripheral blood samples for immunophenotyping analyses were collected at the same time-points. cMRI scans were performed using a 1.5 Tesla scanner. Chi-square, Fisher exact and paired t-test were used to compare groups; all analyses were performed using SAS v9.4. Objectives of the study were: detection of subclinical cardiac damage and identification of groups of patients at major risk, who may benefit from cardiological pre- or/and on-treatment assessment. Results: We present data on the first 47 pts enrolled, diagnosed with a wide range of solid tumors, including 16 renal carcinoma, 11 melanoma and 3 NSCLC; 15 (32%), 16 (34%) and 16 (34%) pts were assigned to the Mono, Combo and Cardio group, respectively. Most pts (42, 89%) were treated with ICI for locally advanced/metastatic disease (26 as first-line therapy, 16 from second-line on), while 5 (11%) as adjuvant therapy. All pts received an anti-PD-(L)1, either as single agent (25, 53%) or in combination, with ICI plus a TKI being the most frequent combinatorial strategy (16; 34%). Overall, the cMRI analysis showed a statistically significant left ventricle ejection fraction (LVEF) reduction pre- versus post-ICI treatment (p 3 points of LVEF. No statistically significant differences in LVEF reduction were observed considering the three different groups (p = 0.6), tumor types (p = 0.2), or occurrence of any grade non-cardiological irAEs (p = 0.6). Conclusions: Our study was able to show a statistically significant reduction in LVEF, with more than 3% LVEF loss in a clinically significant proportion of ICI-treated patients (18; 38%), not selected for suspected cardiac symptoms, warranting prospective evaluation to eventually identify pts at higher risk. The trial is continuing prospective enrollment and immunophenotyping analyses are ongoing.
Losurdo et al. (Sat,) studied this question.