Key result
Hypertension or diabetes linked to ~5.1-fold higher MACE risk in HCC patients on immunotherapy.
Why the study?
First-line immunotherapy for advanced hepatocellular carcinoma is associated with cardiological complications and MACE, and the influence of comorbidities such as arterial hypertension and type 2 diabetes mellitus on the incidence and prognosis of these adverse events remained understudied.
Does the presence of comorbid conditions such as arterial hypertension and type 2 diabetes mellitus increase the incidence of major adverse cardiovascular events and affect overall survival in advanced hepatocellular carcinoma patients receiving first-line immunotherapy?
Cohort (n=109)
Yes
Does the presence of comorbid conditions such as arterial hypertension and type 2 diabetes mellitus increase the incidence of major adverse cardiovascular events and affect overall survival in advanced hepatocellular carcinoma patients receiving first-line immunotherapy?
Odds Ratio: 5.07
p-value: p=0.034
Comorbid arterial hypertension and type 2 diabetes mellitus significantly increase the risk of major adverse cardiovascular events and treatment discontinuation in hepatocellular carcinoma patients receiving first-line immunotherapy, with early cardiological events predicting worse survival.
Comorbidities warrant closer cardiac monitoring during HCC immunotherapy; leaves open whether risk stratification improves outcomes.
INTRODUCTION: Immunotherapy-based combinations have revolutionized the first-line treatment for advanced hepatocellular carcinoma (HCC), improving overall survival (OS). However, these therapies are associated with adverse events (AEs), particularly cardiological complications and major adverse cardiovascular events (MACE), which may adversely affect outcomes. The influence of comorbid conditions such as arterial hypertension (AHT) and type 2 diabetes mellitus (T2DM) on the incidence and prognosis of cardiological AEs in HCC patients remains understudied. METHODS: This retrospective study included 109 HCC patients treated with atezolizumab-bevacizumab, tremelimumab-durvalumab, or durvalumab as first-line therapy at two Spanish medical centers from 2017-2023. Patients were stratified by comorbidities, AE incidence, and cardiological risk (CARDIOSOR scale). The primary endpoints were the incidence of treatment-modifying AEs and MACE, and their association with survival. RESULTS: Among the cohort, 50.5 % experienced AEs of special interest (AESI), with 34 % considered immune-related (irAE). MACE occurred in 7.3 % of patients, including myocarditis (3.7 %). The CARDIOSOR scale identified a higher risk of MACE in patients with AHT, T2DM, or both (OR: 5.07, p = 0.034). Early cardiological AEs were independently associated with worse OS (HR: 3.38, p = 0.04). Patients with both AHT and T2DM exhibited higher rates of MACE (16.7 %) and treatment discontinuation (25.9 %). The CARDIOSOR scale effectively stratified patients into high-risk groups, correlating with increased MACE rates and poor survival outcomes. CONCLUSIONS: Comorbid conditions, particularly AHT and T2DM, amplify the risk of MACE and influence treatment discontinuation. The CARDIOSOR scale is a valuable tool for personalized risk assessment, guiding tailored therapeutic strategies. Integrating cardiovascular risk management into HCC care is crucial for optimizing both oncological and cardiovascular outcomes.
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Fortuny et al. (2025) conducted a cohort in Advanced hepatocellular carcinoma (HCC) (n=109). Comorbid arterial hypertension (AHT), type 2 diabetes mellitus (T2DM), or both during first-line immunotherapy vs. Patients without AHT or T2DM was evaluated on Incidence of treatment-modifying adverse events and major adverse cardiovascular events (MACE), and their association with survival (OR 5.07, p=0.034). Comorbid hypertension or diabetes in HCC patients on immunotherapy increased MACE risk (OR 5.07, p=0.034), and early cardiological AEs worsened overall survival (HR 3.38, p=0.04).
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