Background and aims: Dual immune checkpoint blockade with tremelimumab plus durvalumab (STRIDE) is an established first-line therapy for unresectable hepatocellular carcinoma (uHCC), but real world evidence on safety, toxicity kinetics, and liver function dynamics remains limited. We aimed to evaluate tolerability, on treatment changes in hepatic function and effectiveness, in a multicenter cohort of patients treated with STRIDE in routine practice. Method: We conducted a retrospective analysis of prospectively collected data from 115 consecutive patients with uHCC treated with STRIDEacross12centers inLombardy,Italy.Clinical,biochemical,and radiological variables were recorded at baseline and throughout therapy. AdverseeventsweregradedperCTCAEv5.0,andChild–Pugh was used to assess hepatic functional evolution. Temporal toxicity patterns were evaluated using smoothed hazard functions. Progression-free survival (PFS), overall survival (OS), and competing-risk cumulative incidence of progression and death were examined Results:Medianfollow-upwas 8.9 months. More than 80% of adverse events occurred within the first 2 months; 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; 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 cumulative incidence of 49.2% at 6 months. Conclusion: In routine clinical practice, STRIDE shows reproducible effectiveness and a manageable safety profile, with adverse events incidence clustering early and stabilizing thereafter. Dynamic assessment of liver function shows that hepatic function declines modestly but still clinically meaningfully in affected patients.
FRI-225 Durvalumab–Tremelimumab in advanced hepatocellular carcinoma: real-world data From the LOR-HCC (Lombardy, Italy real-world HCC group)
Corallo, Salvatore;
2026-01-01
Abstract
Background and aims: Dual immune checkpoint blockade with tremelimumab plus durvalumab (STRIDE) is an established first-line therapy for unresectable hepatocellular carcinoma (uHCC), but real world evidence on safety, toxicity kinetics, and liver function dynamics remains limited. We aimed to evaluate tolerability, on treatment changes in hepatic function and effectiveness, in a multicenter cohort of patients treated with STRIDE in routine practice. Method: We conducted a retrospective analysis of prospectively collected data from 115 consecutive patients with uHCC treated with STRIDEacross12centers inLombardy,Italy.Clinical,biochemical,and radiological variables were recorded at baseline and throughout therapy. AdverseeventsweregradedperCTCAEv5.0,andChild–Pugh was used to assess hepatic functional evolution. Temporal toxicity patterns were evaluated using smoothed hazard functions. Progression-free survival (PFS), overall survival (OS), and competing-risk cumulative incidence of progression and death were examined Results:Medianfollow-upwas 8.9 months. More than 80% of adverse events occurred within the first 2 months; 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; 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 cumulative incidence of 49.2% at 6 months. Conclusion: In routine clinical practice, STRIDE shows reproducible effectiveness and a manageable safety profile, with adverse events incidence clustering early and stabilizing thereafter. Dynamic assessment of liver function shows that hepatic function declines modestly but still clinically meaningfully in affected patients.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
