Authors
Pierce KH Chow, Mihir Gandhi, Say-Beng Tan, Maung Win Khin, Ariunaa Khasbazar, Janus Ong, Su Pin Choo, Peng Chung Cheow, Chanisa Chotipanich, Kieron Lim, Laurentius A Lesmana, Tjakra W Manuaba, Boon Koon Yoong, Aloysius Raj, Chiong Soon Law, Ian HY Cua, Rolley R Lobo, Catherine SC Teh, Yun Hwan Kim, Yun Won Jong, Ho-Seong Han, Si-Hyun Bae, Hyun-Ki Yoon, Rheun-Chuan Lee, Chien-Fu Hung, Cheng-Yuan Peng, Po-Chin Liang, Adam Bartlett, Kenneth YY Kok, Choon-Hua Thng, Albert Su-Chong Low, Anthony SW Goh, Kiang Hiong Tay, Richard HG Lo, Brian KP Goh, David CE Ng, Ganesh Lekurwale, Wei Ming Liew, Val Gebski, Kenneth SW Mak, Khee Chee Soo, Asia-Pacific Hepatocellular Carcinoma Trials Group
Publication date
2018/7/1
Journal
Journal of clinical oncology
Volume
36
Issue
19
Pages
1913-1921
Publisher
American Society of Clinical Oncology
Description
Purpose
Selective 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 Methods
SIRveNIB (selective internal radiation therapy v sorafenib), an open-label, investigator-initiated, phase III trial, compared yttrium-90 (90Y) 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.
Results
A total of 360 patients were randomly assigned (RE, 182; sorafenib, 178) from 11 countries in the …
Total citations
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