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.
J Clin Oncol. 2018 Jul 1;36(19):1913-1921. doi: 10.1200/JCO.2017.76.0892. Epub 2018 Mar 2.
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 (Y) 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.
目的 选择性内部放射治疗或放射性栓塞（RE）在不能切除的局限于肝脏的肝细胞癌（HCC）中显示出疗效。本研究比较了 RE 和索拉非尼在局部晚期 HCC 患者中的安全性和疗效。
患者和方法 SIRveNIB（选择性内部放射治疗与索拉非尼）是一项开放标签、研究者发起的、三期临床试验，比较了钇-90（Y）树脂微球 RE 与索拉非尼 800mg/d 在亚太地区 11 个国家的局部晚期 HCC 患者中的疗效，该研究设计为优效/劣势研究。患者按 1:1 随机分组，并按中心和门静脉血栓形成的存在进行分层。主要终点是总生存期（OS）。疗效分析采用意向治疗人群，安全性分析采用治疗人群。
结果 共有 360 名患者（RE 组 182 名，索拉非尼组 178 名）来自亚太地区的 11 个国家。RE 组和索拉非尼组分别有 28.6%和 9.0%的患者未能接受分配的治疗，且无显著交叉至另一组。RE 组和索拉非尼组的中位 OS 分别为 8.8 个月和 10.0 个月（危险比，1.1；95%CI，0.9 至 1.4；P =.36）。共报告了 1468 例治疗出现的不良事件（AE）（RE 组 437 例，索拉非尼组 1031 例）。RE 组发生≥3 级 AE 的患者明显少于索拉非尼组（36/130[27.7%]比 82/162[50.6%]；P<.001）。最常见的≥3 级 AE 是腹水（RE 组 5 例[3.8%]比索拉非尼组 4 例[2.5%]）、腹痛（RE 组 3 例[2.3%]比索拉非尼组 2 例[1.2%]）、贫血（RE 组 0 例比索拉非尼组 4 例[2.5%]）和放射性肝炎（RE 组 2 例[1.5%]比索拉非尼组 0 例[0%]）。RE 组（27/130[20.8%]）发生严重 AE 的患者明显少于索拉非尼组（57/162[35.2%]）。
结论 在局部晚期 HCC 患者中，RE 和索拉非尼的 OS 无显著差异。RE 改善的毒性谱可能为选择患者的治疗提供信息。
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