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SIRveNIB: Selective Internal Radiation Therapy Versus Sorafenib in Asia-Pacific Patients With Hepatocellular Carcinoma

Authors
Chow, Pierce K. H.Gandhi, MihirTan, Say-BengKhin, Maung WinKhasbazar, AriunaaOng, JanusChoo, Su PinCheow, Peng ChungChotipanich, ChanisaLim, KieronLesmana, Laurentius A.Manuaba, Tjakra W.Yoong, Boon KoonRaj, AloysiusLaw, Chiong SoonCua, Ian H. Y.Lobo, Rolley R.Teh, Catherine S. C.Kim, Yun HwanJong, Yun WonHan, Ho-SeongBae, Si-HyunYoon, Hyun-KiLee, Rheun-ChuanHung, Chien-FuPeng, Cheng-YuanLiang, Po-ChinBartlett, AdamKok, Kenneth Y. Y.Thng, Choon-HuaLow, Albert Su-ChongGoh, Anthony S. W.Tay, Kiang HiongLo, Richard H. G.Goh, Brian K. P.Ng, David C. E.Lekurwale, GaneshLiew, Wei MingGebski, ValMak, Kenneth S. W.Soo, Khee Chee
Issue Date
1-7월-2018
Publisher
AMER SOC CLINICAL ONCOLOGY
Citation
JOURNAL OF CLINICAL ONCOLOGY, v.36, no.19, pp.1913 - +
Indexed
SCIE
SCOPUS
Journal Title
JOURNAL OF CLINICAL ONCOLOGY
Volume
36
Number
19
Start Page
1913
End Page
+
URI
https://scholar.korea.ac.kr/handle/2021.sw.korea/74390
DOI
10.1200/JCO.2017.76.0892
ISSN
0732-183X
Abstract
PurposeSelective internal radiation therapy or radioembolization (RE) shows efficacy in unresectable hepatocellular carcinoma (HCC) limited to the liver. This study compared the safety and efficacy of RE and sorafenib in patients with locally advanced HCC.Patients and MethodsSIRveNIB (selective internal radiation therapy v sorafenib), an open-label, investigator-initiated, phase III trial, compared yttrium-90 (Y-90) resin microspheres RE with sorafenib 800 mg/d in patients with locally advanced HCC in a two-tailed study designed for superiority/detriment. Patients were randomly assigned 1:1 and stratified by center and presence of portal vein thrombosis. Primary end point was overall survival (OS). Efficacy analyses were performed in the intention-to-treat population and safety analyses in the treated population.ResultsA total of 360 patients were randomly assigned (RE, 182; sorafenib, 178) from 11 countries in the Asia-Pacific region. In the RE and sorafenib groups, 28.6% and 9.0%, respectively, failed to receive assigned therapy without significant cross-over to either group. Median OS was 8.8 and 10.0 months with RE and sorafenib, respectively (hazard ratio, 1.1; 95% CI, 0.9 to 1.4; P = .36). A total of 1,468 treatment-emergent adverse events (AEs) were reported (RE, 437; sorafenib, 1,031). Significantly fewer patients in the RE than sorafenib group had grade 3 AEs (36 of 130 [27.7%]) v 82 of 162 [50.6%]; P < .001). The most common grade 3 AEs were ascites (five of 130 [3.8%] v four of 162 [2.5%] patients), abdominal pain (three [2.3%] v two [1.2%] patients), anemia (zero v four [2.5%] patients), and radiation hepatitis (two [1.5%] v zero [0%] patients). Fewer patients in the RE group (27 of 130 [20.8%]) than in the sorafenib group (57 of 162 [35.2%]) had serious AEs.ConclusionIn patients with locally advanced HCC, OS did not differ significantly between RE and sorafenib. The improved toxicity profile of RE may inform treatment choice in selected patients.
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