Durvalumab-Tremelimumab in Advanced Hepatocellular Carcinoma: Real-World Data From the LOR-HCC (Lombardy Real-World HCC Group).
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BACKGROUND AND AIM: Dual immune checkpoint blockade with tremelimumab plus durvalumab (STRIDE) is an established first-line therapy for unresectable hepatocellular carcinoma (uHCC); however, real-world evidence on its safety, toxicity kinetics and liver function dynamics remains limited. We aimed to evaluate the tolerability and on-treatment changes in hepatic function and effectiveness in a multicentre cohort of patients treated with STRIDE in routine practice. METHODS: We conducted a retrospective analysis of prospectively collected data from 115 consecutive patients with uHCC treated with STRIDE across 12 centres in Lombardy, Italy. Clinical, biochemical and radiological variables were recorded at baseline and throughout the therapy. Adverse events were graded per CTCAE v5.0, and Child-Pugh was used to assess hepatic functional evolution. The temporal toxicity patterns were evaluated using smoothed hazard functions. Progression-free survival (PFS), overall survival (OS) and competing-risk cumulative incidences of progression and death were examined. RESULTS: The median follow-up was 8.9 months. More than 80% of the adverse events occurred within the first 2 months, and severe toxicities were infrequent. Child-Pugh deterioration from class A to B occurred in 7.8% of patients from baseline to day 28, increasing to 12.1% by day 56. PFS was 5.7 months; the median OS was not reached, with OS rates of 78.2% at 6 months and 53.3% at 18 months. Progression was the predominant early event, with a cumulative incidence of 49.2% at 6 months. CONCLUSIONS: In routine clinical practice, STRIDE shows reproducible effectiveness and a manageable safety profile, with an early and stabilising incidence of adverse events. Dynamic assessment of liver function shows that hepatic function declines modestly but is still clinically meaningful in affected patients.