SIRveNIB: Selective internal radiation therapy versus sorafenib in Asia-Pacific patients with hepatocellular carcinoma

Pierce K.H. 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 H.Y. Cua; Rolley R. Lobo; Catherine S.C. 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 Y.Y. Kok; Choon Hua Thng; Albert Su Chong Low; Anthony S.W. Goh; Kiang Hiong Tay; Richard H.G. Lo; Brian K.P. Goh; David C.E. Ng; Ganesh Lekurwale; Wei Ming Liew; Val Gebski; Kenneth S.W. Mak; Khee Chee Soo

doi:10.1200/JCO.2017.76.0892

SIRveNIB: Selective internal radiation therapy versus sorafenib in Asia-Pacific patients with hepatocellular carcinoma

Pierce K.H. 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 H.Y. Cua, Rolley R. Lobo, Catherine S.C. Teh, Yun Hwan Kim, Yun Won JongHo Seong Han, Si Hyun Bae, Hyun Ki Yoon, Rheun Chuan Lee, Chien Fu Hung, Cheng Yuan Peng, Po Chin Liang, Adam Bartlett, Kenneth Y.Y. Kok, Choon Hua Thng, Albert Su Chong Low, Anthony S.W. Goh, Kiang Hiong Tay, Richard H.G. Lo, Brian K.P. Goh, David C.E. Ng, Ganesh Lekurwale, Wei Ming Liew, Val Gebski, Kenneth S.W. Mak, Khee Chee Soo

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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.

Original language	English
Pages (from-to)	1913-1921
Number of pages	9
Journal	Journal of Clinical Oncology
Volume	36
Issue number	19
DOIs	https://doi.org/10.1200/JCO.2017.76.0892
Publication status	Published - 2018 Jul 1

ASJC Scopus subject areas

Oncology
Cancer Research

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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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., ... Soo, K. C. (2018). SIRveNIB: Selective internal radiation therapy versus sorafenib in Asia-Pacific patients with hepatocellular carcinoma. Journal of Clinical Oncology, 36(19), 1913-1921. https://doi.org/10.1200/JCO.2017.76.0892

Chow, PKH, Gandhi, M, Tan, SB, Khin, MW, Khasbazar, A, Ong, J, Choo, SP, Cheow, PC, Chotipanich, C, Lim, K, Lesmana, LA, Manuaba, TW, Yoong, BK, Raj, A, Law, CS, Cua, IHY, Lobo, RR, Teh, CSC, Kim, YH, Jong, YW, Han, HS, Bae, SH, Yoon, HK, Lee, RC, Hung, CF, Peng, CY, Liang, PC, Bartlett, A, Kok, KYY, Thng, CH, Low, ASC, Goh, ASW, Tay, KH, Lo, RHG, Goh, BKP, Ng, DCE, Lekurwale, G, Liew, WM, Gebski, V, Mak, KSW & Soo, KC 2018, 'SIRveNIB: Selective internal radiation therapy versus sorafenib in Asia-Pacific patients with hepatocellular carcinoma', Journal of Clinical Oncology, vol. 36, no. 19, pp. 1913-1921. https://doi.org/10.1200/JCO.2017.76.0892

@article{e0393a3a970a48f09fcb54685c0dbf1e,

title = "SIRveNIB: Selective internal radiation therapy versus sorafenib in Asia-Pacific patients with hepatocellular carcinoma",

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.",

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

note = "Publisher Copyright: {\textcopyright} 2018 by American Society of Clinical Oncology.",

year = "2018",

month = jul,

day = "1",

doi = "10.1200/JCO.2017.76.0892",

language = "English",

volume = "36",

pages = "1913--1921",

journal = "Journal of Clinical Oncology",

issn = "0732-183X",

publisher = "American Society of Clinical Oncology",

number = "19",

}

TY - JOUR

T1 - SIRveNIB

T2 - Selective internal radiation therapy versus sorafenib in Asia-Pacific patients with hepatocellular carcinoma

AU - Chow, Pierce K.H.

AU - Gandhi, Mihir

AU - Tan, Say Beng

AU - Khin, Maung Win

AU - Khasbazar, Ariunaa

AU - Ong, Janus

AU - Choo, Su Pin

AU - Cheow, Peng Chung

AU - Chotipanich, Chanisa

AU - Lim, Kieron

AU - Lesmana, Laurentius A.

AU - Manuaba, Tjakra W.

AU - Yoong, Boon Koon

AU - Raj, Aloysius

AU - Law, Chiong Soon

AU - Cua, Ian H.Y.

AU - Lobo, Rolley R.

AU - Teh, Catherine S.C.

AU - Kim, Yun Hwan

AU - Jong, Yun Won

AU - Han, Ho Seong

AU - Bae, Si Hyun

AU - Yoon, Hyun Ki

AU - Lee, Rheun Chuan

AU - Hung, Chien Fu

AU - Peng, Cheng Yuan

AU - Liang, Po Chin

AU - Bartlett, Adam

AU - Kok, Kenneth Y.Y.

AU - Thng, Choon Hua

AU - Low, Albert Su Chong

AU - Goh, Anthony S.W.

AU - Tay, Kiang Hiong

AU - Lo, Richard H.G.

AU - Goh, Brian K.P.

AU - Ng, David C.E.

AU - Lekurwale, Ganesh

AU - Liew, Wei Ming

AU - Gebski, Val

AU - Mak, Kenneth S.W.

AU - Soo, Khee Chee

PY - 2018/7/1

Y1 - 2018/7/1

N2 - 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.

AB - 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.

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U2 - 10.1200/JCO.2017.76.0892

DO - 10.1200/JCO.2017.76.0892

M3 - Article

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AN - SCOPUS:85049640422

SN - 0732-183X

VL - 36

SP - 1913

EP - 1921

JO - Journal of Clinical Oncology

JF - Journal of Clinical Oncology

IS - 19

ER -

SIRveNIB: Selective internal radiation therapy versus sorafenib in Asia-Pacific patients with hepatocellular carcinoma

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