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

被引：482

作者：

Chow, Pierce K. H. ^{[1
,2
]}

Gandhi, Mihir ^{[2
,3
]}

Tan, Say-Beng ^{[3
,4
]}

Khin, Maung Win ^{[8
]}

Khasbazar, Ariunaa ^{[9
]}

Ong, Janus ^{[10
,11
]}

Choo, Su Pin ^{[1
]}

Cheow, Peng Chung ^{[5
]}

Chotipanich, Chanisa ^{[15
]}

Lim, Kieron ^{[6
]}

Lesmana, Laurentius A. ^{[16
,17
]}

Manuaba, Tjakra W. ^{[18
]}

Yoong, Boon Koon ^{[19
]}

Raj, Aloysius ^{[20
]}

Law, Chiong Soon ^{[21
]}

Cua, Ian H. Y. ^{[12
]}

Lobo, Rolley R. ^{[13
]}

Teh, Catherine S. C. ^{[14
]}

Kim, Yun Hwan ^{[22
]}

Jong, Yun Won ^{[23
]}

Han, Ho-Seong ^{[24
]}

Bae, Si-Hyun ^{[25
]}

Yoon, Hyun-Ki ^{[26
]}

Lee, Rheun-Chuan ^{[27
]}

Hung, Chien-Fu ^{[29
]}

Peng, Cheng-Yuan ^{[30
]}

Liang, Po-Chin ^{[28
]}

Bartlett, Adam ^{[31
]}

Kok, Kenneth Y. Y. ^{[32
]}

Thng, Choon-Hua ^{[1
]}

Low, Albert Su-Chong ^{[5
]}

Goh, Anthony S. W. ^{[5
]}

Tay, Kiang Hiong ^{[5
]}

Lo, Richard H. G. ^{[5
]}

Goh, Brian K. P. ^{[5
]}

Ng, David C. E. ^{[5
]}

Lekurwale, Ganesh ^{[3
]}

Liew, Wei Ming ^{[3
]}

Gebski, Val ^{[33
]}

Mak, Kenneth S. W. ^{[7
]}

Soo, Khee Chee ^{[1
]}

机构：

[1] Natl Canc Ctr Singapore, Singapore, Singapore

[2] Duke NUS Med Sch, Singapore, Singapore

[3] Singapore Clin Res Inst, Singapore, Singapore

[4] SingHealth, Singapore, Singapore

[5] Singapore Gen Hosp, Singapore, Singapore

[6] Natl Univ Singapore Hosp, Singapore, Singapore

[7] Khoo Teck Puat Hosp, Singapore, Singapore

[8] Yangon GI & Liver Ctr, Yangon, Myanmar

[9] Natl Canc Ctr Mongolia, Ulaanbaatar, Mongolia

[10] Med City, Pasig, Philippines

[11] Univ Philippines Manila, Manila, Philippines

[12] St Lukes Med Ctr Global City, Taguig, Philippines

[13] Davao Doctors Hosp, Davao, Philippines

[14] Makati Med Ctr, Makati, Philippines

[15] Chulabhorn Hosp, Bangkok, Thailand

[16] Cipto Mangunkusumo Hosp, Jakarta, Indonesia

[17] Univ Indonesia, Jakarta, Indonesia

[18] Sanglah Hosp, Denpasar, Indonesia

[19] Univ Malaya, Med Ctr, Kuala Lumpur, Malaysia

[20] Penang Adventist Hosp, George Town, Malaysia

[21] Sarawak Gen Hosp, Kuching, Malaysia

[22] Korea Univ, Anam Hosp, Seoul, South Korea

[23] Severance Hosp, Seoul, South Korea

[24] Seoul Natl Univ, Bundang Hosp, Seoul, South Korea

[25] Seoul St Marys Hosp, Seoul, South Korea

[26] Asan Med Ctr, Seoul, South Korea

[27] Taipei Vet Gen Hosp, Taipei, Taiwan

[28] Natl Taiwan Univ Hosp, Taipei, Taiwan

[29] Chang Gung Mem Hosp, Linkou Branch, Taoyuan, Taiwan

[30] China Med Univ Hosp, Taichung, Taiwan

[31] Auckland City Hosp, Auckland, New Zealand

[32] Brunei Canc Ctr, Jerudong, Brunei

[33] Univ Sydney, Natl Hlth & Med Res Council Clin Trials Ctr, Camperdown, NSW, Australia

来源：

JOURNAL OF CLINICAL ONCOLOGY | 2018年 / 36卷 / 19期

关键词：

Y-90; MICROSPHERES; RADIOEMBOLIZATION; RADIOTHERAPY; MANAGEMENT; PATTERNS; SURVIVAL; OUTCOMES; SARAH;

D O I：

10.1200/JCO.2017.76.0892

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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.

引用

页码：1913 / +

页数：12

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