Subgroup analysis of efficacy and safety of orantinib in combination with TACE in Japanese HCC patients in a randomized phase III trial (ORIENTAL)

Hisashi Hidaka, Namiki Izumi, Takeshi Aramaki, Masafumi Ikeda, Yoshitaka Inaba, Kazuho Imanaka, Takuji Okusaka, Susumu Kanazawa, Shuichi Kaneko, Shinichi Kora, Hiroya Saito, Junji Furuse, Osamu Matsui, Tatsuya Yamashita, Osamu Yokosuka, Satoshi Morita, Hitoshi Arioka, Masatoshi Kudo, Yasuaki Arai

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Abstract

A randomized, phase III trial of orantinib in combination with transcatheter arterial chemoembolization (TACE) did not prolong overall survival (OS) over placebo (ORIENTAL study). A subgroup analysis was conducted to evaluate the efficacy and safety of orantinib in Japanese patients enrolled in the ORIENTAL study. The data of Japanese patients from this study were analyzed. The overall survival (OS), time to progression (TTP), and time to TACE failure (TTTF) were compared between orantinib and placebo arms using stratified log-rank test. Since TTTF in patients with Barcelona Clinic Liver Cancer stage B (BCLC-B) showed favor outcome in this study, the OS and TTTF according to BCLC staging system were also analyzed. The subgroup analysis consisted of 219 and 213 patients in the orantinib and placebo arms. Median OS was 32.5 vs 33.0 months (p = 0.906), median TTP was 4.7 vs 3.1 months (p = 0.011), and median TTTF was 25.3 vs 18.2 months (p = 0.160) in the orantinib and placebo groups, respectively. Patients with BCLC-B in the orantinib and placebo groups showed a median OS of 33.7 and 30.1 months, respectively (p = 0.260), while the corresponding median TTTF were 25.3 and 14.0 months (p = 0.125). The Japanese population safety profile was similar to all over population in the ORIENTAL study. No significant differences were observed in the OS and TTTF though the TTP was significantly improved in the orantinib arm. The OS and TTTF showed a tendency to be prolonged following orantinib treatment of Japanese HCC patients with BCLC-B in the ORIENTAL study.

Original languageEnglish
Article number52
JournalMedical Oncology
Volume36
Issue number6
DOIs
Publication statusPublished - Jun 1 2019

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Keywords

  • Angiogenic factors
  • Molecular targeted agents
  • Platelet-derived growth factor
  • Unresectable HCC
  • Vascular endothelial growth factor

ASJC Scopus subject areas

  • Hematology
  • Oncology
  • Cancer Research

Cite this

Hidaka, H., Izumi, N., Aramaki, T., Ikeda, M., Inaba, Y., Imanaka, K., Okusaka, T., Kanazawa, S., Kaneko, S., Kora, S., Saito, H., Furuse, J., Matsui, O., Yamashita, T., Yokosuka, O., Morita, S., Arioka, H., Kudo, M., & Arai, Y. (2019). Subgroup analysis of efficacy and safety of orantinib in combination with TACE in Japanese HCC patients in a randomized phase III trial (ORIENTAL). Medical Oncology, 36(6), [52]. https://doi.org/10.1007/s12032-019-1272-2