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



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



Journal of Hepatology 2018



To compare clinical outcomes of sorafenib combined with concurrent conventional transarterial chemoembolization (cTACE) (SOR+T) with those of sorafenib alone in patients with advanced hepatocellular carcinoma (HCC) in an investigator-initiated, multicenter, randomized, phase III trial. After randomization, all eligible patients received sorafenib with (Arm C, n=170) or without (Arm S, n=169) cTACE within 3 days and cTACE within 7-21 days, with repeated cTACE on demand (Arm C). The primary endpoint was overall survival (OS). For Arms C and S, the median OS was 12.8 vs. 10.8 months (hazard ratio [HR], 0.91; 90% confidence interval [CI] 0.69-1.21; P=.290); median time to progression (TTP), 5.3 vs. 3.5 months (HR, 0.67; 90% CI, 0.53-0.85; P=.003); median progression-free survival (PFS), 5.2 vs. 3.6 months (HR, 0.73; 90% CI, 0.59-0.91; P=.01); and tumor response rate (TRR), 60.6% vs. 47.3% (P=.005). For Arms C and S, serious adverse events (AEs) were 33.3% vs. 19.8% (P=.006), and grade ≥3 AEs 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%), hyponatremia (5.2% vs. 0%) (P<.05), hand-foot skin reaction (10.5% vs. 11.4%), encephalopathy (5.2% vs. 1.2%), and diarrhea (5.2% vs. 4.2%). A post-hoc subgroup analysis showed survival in Arm C patients (46.4%) receiving ≥2 cTACE sessions compared to Arm S patients (18.6 vs. 10.8 m; HR, 0.58; 95% CI, 0.40-0.82; P=.006). Compared with sorafenib alone, the SOR+T therapy did not improve OS in patients with advanced HCC. However, the SOR+T therapy significantly improved TTP, PFS, and TRR. Sorafenib alone treatment remains the first-line standard care for patients with advanced HCC LAY SUMMARY: For patients with advanced hepatocellular carcinoma requiring sorafenib therapy, conventional transarterial chemoemboliztion(TACE) co-administration did not show improved therapeutic efficacy compared to sorafenib alone.

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Accession: 065989029

Download citation: RISBibTeXText

PMID: 30529387

DOI: 10.1016/j.jhep.2018.11.029


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