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

Research output: Contribution to journalArticle

78 Citations (Scopus)

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 languageEnglish
Pages (from-to)1913-1921
Number of pages9
JournalJournal of Clinical Oncology
Volume36
Issue number19
DOIs
Publication statusPublished - 2018 Jul 1

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Hepatocellular Carcinoma
Radiotherapy
sorafenib
Survival
Safety
Yttrium
Portal Vein
Microspheres
Ascites
Abdominal Pain
Hepatitis
Population
Anemia
Thrombosis
Therapeutics
Research Personnel
Radiation
Liver

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

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.

In: Journal of Clinical Oncology, Vol. 36, No. 19, 01.07.2018, p. 1913-1921.

Research output: Contribution to journalArticle

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
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. / SIRveNIB : Selective internal radiation therapy versus sorafenib in Asia-Pacific patients with hepatocellular carcinoma. In: Journal of Clinical Oncology. 2018 ; Vol. 36, No. 19. pp. 1913-1921.
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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}",
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month = "7",
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",
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}

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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