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J Clin Oncol. 2018 Jul 1;36(19):1913-1921. doi: 10.1200/JCO.2017.76.0892. Epub 2018 Mar 2.

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

Author information

1
Pierce K.H. Chow, Su Pin Choo, Choon-Hua Thng, and Khee Chee Soo, National Cancer Centre Singapore; Pierce K.H. Chow and Mihir Gandhi, Duke-NUS Medical School; Mihir Gandhi, Say-Beng Tan, Ganesh Lekurwale, and Wei Ming Liew, Singapore Clinical Research Institute; Say-Beng Tan, SingHealth; Peng Chung Cheow, Albert Su-Chong Low, Anthony S.W. Goh, Kiang Hiong Tay, Richard H.G. Lo, Brian K.P. Goh, and David C.E. Ng, Singapore General Hospital; Kieron Lim, National University Hospital; Kenneth S.W. Mak, Khoo Teck Puat Hospital, Singapore; Maung Win Khin, Yangon GI and Liver Centre, Yangon, Myanmar; Ariunaa Khasbazar, National Cancer Center of Mongolia, Ulaanbaatar, Mongolia; Janus Ong, The Medical City, Pasig, and University of the Philippines Manila, Manila; Ian H.Y. Cua, St Luke's Medical Center-Global City, Taguig; Rolley R. Lobo, Davao Doctors Hospital, Davao; Catherine S.C. Teh, Makati Medical Center, Makati City, Philippines; Chanisa Chotipanich, Chulabhorn Hospital, Bangkok, Thailand; Laurentius A. Lesmana, Cipto Mangunkusumo Hospital, and University of Indonesia, Jakarta; Tjakra W. Manuaba, Sanglah Hospital, Denpasar, Indonesia; Boon Koon Yoong, University of Malaya Medical Centre, Kuala Lumpur; Aloysius Raj, Penang Adventist Hospital, Penang; Chiong Soon Law, Sarawak General Hospital, Kuching, Malaysia; Yun Hwan Kim, Korea University Anam Hospital; Yun Won Jong, Severance Hospital; Ho-Seong Han, Seoul National University Bundang Hospital; Si-Hyun Bae, Seoul St Mary's Hospital; Hyun-Ki Yoon, Asan Medical Center, Seoul, Republic of Korea; Rheun-Chuan Lee, Taipei Veterans General Hospital; Po-Chin Liang, National Taiwan University Hospital, Taipei; Chien-Fu Hung, Chang Gung Memorial Hospital Linkou Branch, Taoyuan, Cheng-Yuan Peng, China Medical University Hospital, Taichung, Taiwan; Adam Bartlett, Auckland City Hospital, Auckland, New Zealand; Kenneth Y.Y. Kok, The Brunei Cancer Centre, Jerudong, Brunei Darussalam; and Val Gebski, University of Sydney, National Health and Medical Research Council Clinical Trials Centre, Camperdown, New South Wales, Australia.

Abstract

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 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. Conclusion In 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.

PMID:
29498924
DOI:
10.1200/JCO.2017.76.0892

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