Sorafenib with or without concurrent transarterial chemoembolization in patients with advanced hepatocellular carcinoma: The phase III STAH trial.

Autor: Park JW; National Cancer Center, Korea, South Korea. Electronic address: jwpark@ncc.re.kr., Kim YJ; Seoul National University Hospital, South Korea., Kim DY; Severance Hospital, South Korea., Bae SH; The Catholic University of Korea, South Korea; Seoul St. Mary's Hospital, South Korea., Paik SW; Samsung Medical Center, South Korea., Lee YJ; Inje University Busan Paik Hospital, South Korea., Kim HY; SNU Boramae Medical Center, South Korea., Lee HC; Asan Medical Center, University of Ulsan, South Korea., Han SY; Dong-A University Hospital, South Korea., Cheong JY; Ajou University Hospital, South Korea., Kwon OS; Gachon University Gil Medical Center, South Korea., Yeon JE; Korea University Guro Hospital, South Korea., Kim BH; National Cancer Center, Korea, South Korea., Hwang J; Keimyung University Dongsan Medical Center, South Korea.
Jazyk: angličtina
Zdroj: Journal of hepatology [J Hepatol] 2019 Apr; Vol. 70 (4), pp. 684-691. Date of Electronic Publication: 2018 Dec 06.
DOI: 10.1016/j.jhep.2018.11.029
Abstrakt: Background & Aims: Sorafenib is first-line standard of care for patients with advanced hepatocellular carcinoma (HCC), yet it confers limited survival benefit. Therefore, we aimed to compare clinical outcomes of sorafenib combined with concurrent conventional transarterial chemoembolization (cTACE) vs. sorafenib alone in patients with advanced HCC.
Methods: In this investigator-initiated, multicenter, phase III trial, patients were randomized to receive sorafenib alone (Arm S, n = 169) or in combination with cTACE on demand (Arm C, n = 170). Sorafenib was started within 3 days and cTACE within 7-21 days of randomization. The primary endpoint was overall survival (OS).
Results: For Arms C and S, the median OS was 12.8 vs. 10.8 months (hazard ratio [HR] 0.91; 90% CI 0.69-1.21; p = 0.290); median time to progression, 5.3 vs. 3.5 months (HR 0.67; 90% CI 0.53-0.85; p = 0.003); median progression-free survival, 5.2 vs. 3.6 months (HR 0.73; 90% CI 0.59-0.91; p = 0.01); and tumor response rate, 60.6% vs. 47.3% (p = 0.005). For Arms C and S, serious (grade ≥3) adverse events occurred in 33.3% vs. 19.8% (p = 0.006) of patients and included increased alanine aminotransferase levels (20.3% vs. 3.6%), hyperbilirubinemia (11.8% vs. 3.0%), ascites (11.8% vs. 4.2%), thrombocytopenia (7.2% vs. 1.2%), anorexia (7.2% vs. 1.2%), and hand-foot skin reaction (10.5% vs. 11.4%). A post hoc subgroup analysis compared OS in Arm C patients (46.4%) receiving ≥2 cTACE sessions to Arm S patients (18.6 vs. 10.8 months; HR 0.58; 95% CI 0.40-0.82; p = 0.006).
Conclusion: Compared with sorafenib alone, sorafenib combined with cTACE did not improve OS in patients with advanced HCC. However, sorafenib combined with cTACE significantly improved time to progression, progression-free survival, and tumor response rate. Sorafenib alone remains the first-line standard of care for patients with advanced HCC.
Lay Summary: For patients with advanced hepatocellular carcinoma requiring sorafenib therapy, co-administration with conventional transarterial chemoembolization did not improve overall survival compared to sorafenib alone. Therefore, sorafenib alone remains the first-line standard of care for patients with advanced hepatocellular carcinoma. Clinical Trial Number: NCT01829035.
(Copyright © 2018 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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