Pathological response following neoadjuvant immune checkpoint inhibitors in patients with hepatocellular carcinoma: a cross-trial, patient-level analysis

作者：Antonio D’Alessio, Bernardo Stefanini, Julia Blanter, Benjamin Adegbite, Fionnuala Crowley, Vincent Yip, Sarah Slater, Claudia Angela Maria Fulgenzi, Ciro Celsa, Giulia Francesca Manfredi, Madhava Pai, Robert Goldin, Stephen C. Ward, Maria Isabel Fiel, Daniel Shu, Yung‐Yeh Su, Alessio Cortellini, Marina Baretti, Robert Anders, Mark Yarchoan, Chiun Hsu, Thomas U. Marron, David J. Pinato · 发表于：The Lancet Oncology · 年份：2024 · DOI：10.1016/s1470-2045(24)00457-1 · 被引用次数：77 · 研究领域：Hepatocellular Carcinoma Treatment and Prognosis、Cancer Immunotherapy and Biomarkers、Inflammatory Biomarkers in Disease Prognosis

BACKGROUND: Neoadjuvant use of immune checkpoint inhibitors (ICIs) before liver resection results in pathological tumour regression in patients with hepatocellular carcinoma. We aimed to describe the characteristics of pathological responses after preoperative ICI therapy for hepatocellular carcinoma and to evaluate the association between the depth of tumour regression and relapse-free survival. METHODS: In this cross-trial, patient-level analysis, we performed a pooled analysis of data from patients with hepatocellular carcinoma receiving ICI therapy before liver resection as part of a global collaborative consortium (NeoHCC) of five phase 1 and 2 clinical trials and standardised observational protocols conducted in 12 tertiary referral centres across the USA, UK, and Taiwan. Eligible patients were adults (aged ≥18 years) diagnosed with hepatocellular carcinoma by tissue core biopsy before treatment initiation, a Liver Imaging Reporting and Data System score of 5 on imaging, or both, with an Eastern Cooperative Oncology Group performance status score of 0-1, and no extrahepatic spread or previous ICI treatment. Pathological response was measured as the percentage of non-viable tumour in the resected surgical specimen, with major pathological response corresponding to at least 70% tumour regression and pathological complete response corresponding to 100% tumour regression. We correlated pathological response with radiological overall response using RECIST criteria (version 1...