Analysis of patients (pts) with unresectable hepatocellular carcinoma (uHCC) and Child–Pugh (CP)-B liver function treated with regorafenib in routine clinical practice in the observational REFINE study.

• DOI: 10.1200/jco.2024.42.3_suppl.452
• Publication Date: 2024-01-22T21:12:58Z
• Authors: Yoon Jun Kim; Philippe Merle; Richard S. Finn; Masatoshi Kudo; Heinz-Josef Klümpen; Ho Yeong Lim; Matthias Pinter; Svetlana Babajanyan; Javeed Khan; Maria Awan; Kirhan Özgürdal; Shukui Qin
• Keywords: Regorafenib; Clinical endpoint; Liver function

452 Background: Pts with HCC and compromised liver function are typically excluded from clinical trials. The REFINE real-world study (NCT03289273) assessed a more varied pt population treated regorafenib than the phase 3 RESORCE trial. 1 Median overall survival (OS) in was 13.2 months treatment-emergent adverse events (TEAEs) were consistent RESORCE. We present subgroup analysis of outcomes pts CP-B function. Methods: is an international, prospective observational uHCC for whom decision to treat according local health authority approved label made by their physician before enrollment. primary endpoints safety (Medical Dictionary Regulatory Activities v25) dose modifications due drug-related TEAEs. Secondary included OS duration treatment (DoT). Results: Of 1005 evaluable pts, 123 (12%) classified as at entry, most being CP-B7 (Table). 40/123 (9%), 9/123 (18%), 58/123 (15%) initiated 160 mg, 120 80 per day, respectively. DoT 2.3 3.7 cohort. Incidence rates TEAEs cohort similar (93% 92%) 70% 74% Grade 3–4 occurred 41% 39% 27% 26% Serious observed 48% 37% cohort, 11% 9% Drug-related led less frequent (28% vs 37%), but permanent discontinuations 16%). 6.3 (95% confidence interval [CI] 4.9, 7.8) 6.7 CI 5.1, 8.7) months. Conclusions: In REFINE, had grade TEAEs, higher occurrence serious underlying cirrhosis pts. comparable overall. evaluation prognostic models identify subgroups who may benefit subject further research. 1. Kim YJ, ILCA 2022. [Table: see text]