Sorafenib with or without concurrent transarterial chemoembolization in patients with advanced hepatocellular carcinoma: The phase III STAH trial
- 주제(키워드) Hepatocellular carcinoma , Sorafenib , Transarterial chemoembolization , Combination treatment
- 주제(기타) Gastroenterology & Hepatology
- 설명문(일반) [Park, Joong-Won; Kim, Bo Hyun] Natl Canc Ctr, Goyang, Gyeonggi Do, South Korea; [Kim, Yoon Jun] Seoul Natl Univ Hosp, Seoul, South Korea; [Kim, Do Young] Severance Hosp, Seoul, South Korea; [Bae, Si-Hyun] Catholic Univ Korea, Seoul, South Korea; [Bae, Si-Hyun] Seoul St Marys Hosp, Seoul, South Korea; [Paik, Seung Woon] Samsung Med Ctr, Seoul, South Korea; [Lee, Youn-Jae] Inje Univ, Busan Paik Hosp, Busan, South Korea; [Kim, Hwi Young] SNU Boramae Med Ctr, Seoul, South Korea; [Lee, Han Chu] Univ Ulsan, Asan Med Ctr, Ulsan, South Korea; [Han, Sang Young] Dong A Univ Hosp, Busan, South Korea; [Cheong, Jae Youn] Ajou Univ Hosp, Suwon, South Korea; [Kwon, Oh Sang] Gachon Univ, Gil Med Ctr, Seongnam, South Korea; [Yeon, Jong Eun] Korea Univ, Guro Hosp, Seoul, South Korea; [Hwang, Jaeseok] Keimyung Univ, Dongsan Med Ctr, Daegu, South Korea; [Kim, Hwi Young] Ewha Womans Univ, Coll Med, Dept Internal Med, Seoul, South Korea
- 등재 SCIE, SCOPUS
- OA유형 hybrid
- 발행기관 ELSEVIER SCIENCE BV
- 발행년도 2019
- URI http://www.dcollection.net/handler/ewha/000000160416
- 본문언어 영어
- Published As http://dx.doi.org/10.1016/j.jhep.2018.11.029
- PubMed https://pubmed.ncbi.nlm.nih.gov/30529387
초록/요약
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. (C) 2018 European Association for the Study of the Liver. Published by Elsevier B.V.
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