TY - JOUR
T1 - Subgroup analysis of efficacy and safety of orantinib in combination with TACE in Japanese HCC patients in a randomized phase III trial (ORIENTAL)
AU - Hidaka, Hisashi
AU - Izumi, Namiki
AU - Aramaki, Takeshi
AU - Ikeda, Masafumi
AU - Inaba, Yoshitaka
AU - Imanaka, Kazuho
AU - Okusaka, Takuji
AU - Kanazawa, Susumu
AU - Kaneko, Shuichi
AU - Kora, Shinichi
AU - Saito, Hiroya
AU - Furuse, Junji
AU - Matsui, Osamu
AU - Yamashita, Tatsuya
AU - Yokosuka, Osamu
AU - Morita, Satoshi
AU - Arioka, Hitoshi
AU - Kudo, Masatoshi
AU - Arai, Yasuaki
N1 - Funding Information:
Acknowledgements We thank all the patients, their families, and the investigators who participated in the study. We thank Yuji Matsuda, Taiho Pharmaceutical for his support in compiling and writing this report. The study was designed by Taiho Pharmaceutical in conjunction with the principal academic investigator. Data collection was performed by EPS. BSR Corporation performed the statistical analysis of the collected data. Data were managed in parallel by the study’s sponsor and its principal investigator. This study was sponsored by Taiho Pharmaceutical Co., Ltd.
Funding Information:
We thank all the patients, their families, and the investigators who participated in the study. We thank Yuji Matsuda, Taiho Pharmaceutical for his support in compiling and writing this report. The study was designed by Taiho Pharmaceutical in conjunction with the principal academic investigator. Data collection was performed by EPS. BSR Corporation performed the statistical analysis of the collected data. Data were managed in parallel by the study’s sponsor and its principal investigator. This study was sponsored by Taiho Pharmaceutical Co., Ltd.
Funding Information:
Conflicts of interest statement Hidaka H has received personal fees from Taiho Pharmaceutical. Izumi N has received personal fees from Gilead, AbbVie, Otsuka and Shionogi. Aramaki T has received personal fees from Taiho. Ikeda M has received: personal fees from Taiho, Bayer, Eisai,Bristol-Myers Squibb, Eli Lilly Japan, Daiichi-Sankyo, Kyowa Hakko Kirin, Novartis Pharma, Yakult, Abbott Japan, Chugai Pharmaceutical, Nippon Kayaku, Otsuka, Pharmaceutical and Bristol-Myers Squibb. Ikeda M has received other from Taiho Pharmaceutical, Bayer Yakuhin, Eisai, Bristol-Myers Squibb, Eli Lilly Japan, Daiichi-Sankyo, Kyowa Hakko Kirin, TEIJIN PHARMA, Novartis Pharma, Shire, Chugai Pharmaceutical, Ono Pharmaceutical, AstraZeneca, Zeria Pharmaceutical, Baxter, Kowa, Boehringer Ingelheim, Glaxo Smithkline, Nano Carrier, ASLAN Pharmaceuticals. Inaba Y has received personal fees from Eisai, Medicon, Bayer Yakuhin, Guerbet Japan, Nippon Kayaku, Canon Medical Systems, Toray Medical. Oku-saka T has received other from Merck Serono, Suimtomo Dainippon, Yakult, Ono, Novartis, Eli Lilly Japan, Chugai, AstraZeneca, Eisai and Baxter. Kaneko S has received other from Taiho. Furuse J has received: grant from Taiho, Yakult, Eli Lilly Japan, Chugai, Eisai, Ono, Kyowa Hakko Kirin, Sumitomo Dainippon, Astellas, MSD, J-Pharma, Daiichi Sankyo, Janssen, Zeria, Merck Serono, Onco Therapy Science, Bayer, Takeda, Shire, Pfizer, Bristol-Myers Squibb, Novartis, Astra Zeneca, Mochida and Shionogi; personal fees from Taiho, Yakult, Eli Lilly japan, Chugai, Eisai, Ono, Kyowa Hakko Kirin, Sumitomo Dainip-pon, Astellas, J-Pharma, Daiichi Sankyo, Zeria, Merck Serono, Bayer, Takeda, Shire, Pfizer, Bristol-Myers Squibb, Novartis, Astra Zeneca, Mochida, Shionogi, EA Pharma, Mitsubishi Tanabe, Sawai, Sanofy, Sandoz, Boehringer Ingelheim, Otsuka and Fujifilm. Yamashita T has received personal fees from Taiho Pharmaceutical. Yokosuka O has received other from Tanabe-Mitsubishi, Otsuka, Eisai, Daiichi San-kyo, MSD, Gilead, Chugai, Astellas, Takeda and Sumitomo Dainip-pon. Morita S has received personal fees from Taiho. Arioka H has received personal fees from Taiho and Chugai. Kudo M has received: grant from Taiho, Chugai, Otsuka, Takeda, Sumitomo Dainippon, Daiichi Sankyo, MSD, Eisai, Bayer, Abbvie, Medico’s Hirata, Astellas Pharma and Bristol-Myers Squibb; personal fees from Taiho, MSD, Eisai, Bayer and Ajinomoto. Arai Y has received personal fees from Taiho. All remaining authors have declared no conflicts of interest.
Publisher Copyright:
© 2019, The Author(s).
PY - 2019/6/1
Y1 - 2019/6/1
N2 - 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.
AB - 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.
KW - Angiogenic factors
KW - Molecular targeted agents
KW - Platelet-derived growth factor
KW - Unresectable HCC
KW - Vascular endothelial growth factor
UR - http://www.scopus.com/inward/record.url?scp=85065236740&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85065236740&partnerID=8YFLogxK
U2 - 10.1007/s12032-019-1272-2
DO - 10.1007/s12032-019-1272-2
M3 - Article
C2 - 31053989
AN - SCOPUS:85065236740
SN - 1357-0560
VL - 36
JO - Medical Oncology
JF - Medical Oncology
IS - 6
M1 - 52
ER -
