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

Chow, Pierce K.H., Gandhi, Mihir, Tan, Say-Beng, Khin, Maung Win, Khasbazar, Ariunaa, Ong, Janus, Choo, Su Pin, Cheow, Peng Chung, Chotipanich, Chanisa, Lim, Kieron, Lesmana, Laurentius A., Manuaba, Tjakra W., Yoong, Boon Koon, Raj, Aloysius, Law, Chiong Soon, Cua, Ian H.Y., Lobo, Rolley R., Teh, Catherine S.C., Kim, Yun Hwan, Jong, Yun Won, Han, Ho-Seong, Bae, Si-Hyun, Yoon, Hyun-Ki, Lee, Rheun-Chuan, Hung, Chien-Fu, Peng, Cheng-Yuan, Liang, Po-Chin, Bartlett, Adam, Kok, Kenneth Y.Y., Thng, Choon-Hua, Low, Albert Su-Chong, Goh, Anthony S.W., Tay, Kiang Hiong, Lo, Richard H.G., Goh, Brian K.P., Ng, David C.E., Lekurwale, Ganesh, Liew, Wei Ming, Gebski, Val, Mak, Kenneth S.W., Soo, Khee Chee, on behalf of Asia-Pacific Hepatocellular Carcinoma Trials Group·2018·Journal of Clinical Oncology

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 (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.

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Authors
Chow, P. K. H., Gandhi, M., Tan, S.-B., Khin, M. W., Khasbazar, A., Ong, J., Choo, S. P., Cheow, P. C., Chotipanich, C., Lim, K., Lesmana, L. A., Manuaba, T. W., Yoong, B. K., Raj, A., Law, C. S., Cua, I. H. Y., Lobo, R. R., Teh, C. S. C., Kim, Y. H., Jong, Y. W., Han, H.-S., Bae, S.-H., Yoon, H.-K., Lee, R.-C., Hung, C.-F., Peng, C.-Y., Liang, P.-C., Bartlett, A., Kok, K. Y. Y., Thng, C.-H., Low, A. S.-C., Goh, A. S. W., Tay, K. H., Lo, R. H. G., Goh, B. K. P., Ng, D. C. E., Lekurwale, G., Liew, W. M., Gebski, V., Mak, K. S. W., Soo, K. C., & on behalf of Asia-Pacific Hepatocellular Carcinoma Trials Group
Venue
Journal of Clinical Oncology
Published
2018-07-01
Volume
36
Issue
19
Pages
1913-1921
ISSN
  • 0732-183X (ISSN-L)
  • 1527-7755
OpenAlex
W2791703762
Cited by
658
References
27
FWCI
43.34
Type
journal article
Language
en
Open access
closed

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CoChat. (2026). Citation check: SIRveNIB: Selective Internal Radiation Therapy Versus Sorafenib in Asia-Pacific Patients With Hepatocellular Carcinoma. https://app.cochat.ai/papers/10.1200/jco.2017.76.0892
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Chow, P. K. H., Gandhi, M., Tan, S.-B., Khin, M. W., Khasbazar, A., Ong, J., Choo, S. P., Cheow, P. C., Chotipanich, C., Lim, K., Lesmana, L. A., Manuaba, T. W., Yoong, B. K., Raj, A., Law, C. S., Cua, I. H. Y., Lobo, R. R., Teh, C. S. C., Kim, Y. H., . . . on behalf of Asia-Pacific Hepatocellular Carcinoma Trials Group. (2018). SIRveNIB: Selective Internal Radiation Therapy Versus Sorafenib in Asia-Pacific Patients With Hepatocellular Carcinoma. Journal of Clinical Oncology. https://doi.org/10.1200/jco.2017.76.0892

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Bibliographic data: Semantic Scholar, OpenAlex, Crossref.

Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

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