Sorafenib with or without concurrent transarterial chemoembolization in patients with advanced hepatocellular carcinoma: The phase III STAH trial.
J Hepatol
; 70(4): 684-691, 2019 04.
Article
in En
| MEDLINE
| ID: mdl-30529387
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, nâ¯=â¯169) or in combination with cTACE on demand (Arm C, nâ¯=â¯170). Sorafenib was started within 3â¯days and cTACE within 7-21â¯days of randomization. The primary endpoint was overall survival (OS).RESULTS:
For Arms C and S, the median OS was 12.8 vs. 10.8â¯months (hazard ratio [HR] 0.91; 90% CI 0.69-1.21; pâ¯=â¯0.290); median time to progression, 5.3 vs. 3.5â¯months (HR 0.67; 90% CI 0.53-0.85; pâ¯=â¯0.003); median progression-free survival, 5.2 vs. 3.6â¯months (HR 0.73; 90% CI 0.59-0.91; pâ¯=â¯0.01); and tumor response rate, 60.6% vs. 47.3% (pâ¯=â¯0.005). For Arms C and S, serious (grade ≥3) adverse events occurred in 33.3% vs. 19.8% (pâ¯=â¯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. 10.8â¯months; HR 0.58; 95% CI 0.40-0.82; pâ¯=â¯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. LAYSUMMARY:
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.Key words
Full text:
1
Database:
MEDLINE
Therapeutic Methods and Therapies TCIM:
Terapias_biologicas
/
Aromoterapia
Main subject:
Chemoembolization, Therapeutic
/
Carcinoma, Hepatocellular
/
Sorafenib
/
Liver Neoplasms
/
Antineoplastic Agents
Type of study:
Clinical_trials
/
Etiology_studies
/
Observational_studies
/
Prognostic_studies
/
Risk_factors_studies
Language:
En
Journal:
J Hepatol
Year:
2019
Type:
Article