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

Authors
Park, Joong-WonKim, Yoon JunKim, Do YoungBae, Si-HyunPaik, Seung WoonLee, Youn-JaeKim, Hwi YoungLee, Han ChuHan, Sang YoungCheong, Jae YounKwon, Oh SangYeon, Jong EunKim, Bo HyunHwang, Jaeseok
Issue Date
Apr-2019
Publisher
Elsevier BV
Keywords
Hepatocellular carcinoma; Sorafenib; Transarterial chemoembolization; Combination treatment
Citation
Journal of Hepatology, v.70, no.4, pp.684 - 691
Indexed
SCIE
SCOPUS
Journal Title
Journal of Hepatology
Volume
70
Number
4
Start Page
684
End Page
691
URI
https://scholarworks.korea.ac.kr/kumedicine/handle/2020.sw.kumedicine/2197
DOI
10.1016/j.jhep.2018.11.029
ISSN
0168-8278
Abstract
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.
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Guro Hospital (Department of Gastroenterology and Hepatology, Guro Hospital)
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