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

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Author(s)
Joong-Won ParkYoon Jun KimDo Young KimSi-Hyun BaeSeung Woon PaikYoun-Jae LeeHwi Young KimHan Chu LeeSang Young HanJae Youn CheongOh Sang Kwon, Jong Eun Yeon, Bo Hyun Kim, Jaeseok Hwang
Keimyung Author(s)
Hwang, Jae Seok
Department
Dept. of Internal Medicine (내과학)
Journal Title
Journal of Hepatology
Issued Date
2019
Volume
70
Issue
4
Keyword
Hepatocellular carcinomaSorafenibTransarterial chemoembolizationCombination treatment.
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 ArmsC and S, themedianOSwas 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 ith advanced hepatocellular carcinoma.
Keimyung Author(s)(Kor)
황재석
Publisher
School of Medicine (의과대학)
Citation
Joong-Won Park et al. (2019). Sorafenib with or without concurrent transarterial chemoembolization in patients with advanced hepatocellular carcinoma: The phase III STAH trial. Journal of Hepatology, 70(4), 684–691. doi: 10.1016/j.jhep.2018.11.029
Type
Article
ISSN
1600-0641
Source
https://www.clinicalkey.com/#!/content/playContent/1-s2.0-S0168827818325807
DOI
10.1016/j.jhep.2018.11.029
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/41836
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Internal Medicine (내과학)
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