Reproducible safety and efficacy of durvalumab with or without tremelimumab for hepatocellular carcinoma in clinical practice: Results of the DT-real study

作者：Ciro Celsa, Tiziana Pressiani, Naoshi Nishida, Shadi Chamseddine, Ashwini Arvind, Michael Li, Marta Fortuny, Najib Ben Khaled, Massimo Iavarone, Hidenori Toyoda, Ilario Giovanni Rapposelli, Andrea Casadei‐Gardini, Caterina Vivaldi, Susanna V. Ulahannan, Haripriya Andanamala, Bernhard Scheiner, Matthias Pinter, Elena Orlandi, Claudia Angela Maria Fulgenzi, Giulia Francesca Manfredi, Pasquale Lombardi, Antonio D’Alessio, Bernardo Stefanini, Rosanna Villani, Francesca Romana Ponziani, Leonardo Stella, Ornella Carminati, Angela Dalia Ricci, Melina Gonzalez, Alba Sparacino, Gabriele Di Maria, Marco Vaccaro, Giuseppe Cabibbo, Calogero Cammà, María Reig, Robin Kate Kelley, Amit G. Singal, Ahmed O. Kaseb, Masatoshi Kudo, Lorenza Rimassa, David J. Pinato · 发表于：JHEP Reports · 年份：2025 · DOI：10.1016/j.jhepr.2025.101685 · 被引用次数：2 · 研究领域：Hepatocellular Carcinoma Treatment and Prognosis、Cancer Immunotherapy and Biomarkers、Liver physiology and pathology

Background & Aims: Durvalumab plus tremelimumab (STRIDE) has emerged as a first-line systemic treatment option for unresectable hepatocellular carcinoma (HCC). This international multicentre study aimed to evaluate the efficacy and tolerability of STRIDE or durvalumab monotherapy in routine clinical practice, comparing outcomes between patients within and outside key eligibility criteria for the HIMALAYA trial. Methods: From a database of 1,423 patients with advanced/unresectable HCC treated with immunotherapy across 35 centres, we analysed 233 patients receiving STRIDE or durvalumab monotherapy. Patients were categorized as HIMALAYA-IN or HIMALAYA-OUT based on key trial eligibility criteria (no prior systemic therapy, ECOG-PS 0-1, Child-Pugh class A, no Vp4 thrombosis). Baseline characteristics were assessed for overall survival (OS) and hepatic decompensation using a multivariable Cox model and competing-risk analysis, respectively. Objective response rates and treatment-related adverse events were recorded. Results: = 0.03). Macrovascular invasion and hepatic decompensation were independent negative prognostic factors in the whole cohort. Hepatic decompensation occurred in 10.5% of patients within 12 months from treatment start. Objective response rate was 23.7% and 17.8% of HIMALAYA-IN and -OUT patients, respectively. Patients achieving disease control (whole cohort: 59.4%) demonstrated 24-month OS of 58.2% in HIMALAYA-IN and 44.8% in HIMALAYA-OUT groups. Grade 3-4 treatm...