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 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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ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

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