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J Hepatol. 2019 Apr;70(4):684-691. doi: 10.1016/j.jhep.2018.11.029. Epub 2018 Dec 6.

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

Author information

1
National Cancer Center, Korea, South Korea. Electronic address: jwpark@ncc.re.kr.
2
Seoul National University Hospital, South Korea.
3
Severance Hospital, South Korea.
4
The Catholic University of Korea, South Korea; Seoul St. Mary's Hospital, South Korea.
5
Samsung Medical Center, South Korea.
6
Inje University Busan Paik Hospital, South Korea.
7
SNU Boramae Medical Center, South Korea.
8
Asan Medical Center, University of Ulsan, South Korea.
9
Dong-A University Hospital, South Korea.
10
Ajou University Hospital, South Korea.
11
Gachon University Gil Medical Center, South Korea.
12
Korea University Guro Hospital, South Korea.
13
National Cancer Center, Korea, South Korea.
14
Keimyung University Dongsan Medical Center, South Korea.

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.

KEYWORDS:

Combination treatment; Hepatocellular carcinoma; Sorafenib; Transarterial chemoembolization

PMID:
30529387
DOI:
10.1016/j.jhep.2018.11.029
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