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

Journal Article · Sat Jun 15 04:00:00 EDT 2019 · Medical Oncology (Online)

DOI:https://doi.org/10.1007/S12032-019-1272-2· OSTI ID:22938415

Hidaka, Hisashi ^[1]; Izumi, Namiki ^[2]; Aramaki, Takeshi ^[3]; Ikeda, Masafumi ^[4]; Inaba, Yoshitaka ^[5]; Imanaka, Kazuho ^[6]; Okusaka, Takuji ^[7]; Kanazawa, Susumu ^[8]; Kaneko, Shuichi ^[9]; Kora, Shinichi ^[10]; Saito, Hiroya ^[11]; Furuse, Junji ^[12]; Matsui, Osamu ^[13]; Yamashita, Tatsuya ^[9]; Yokosuka, Osamu ^[14]; Morita, Satoshi ^[15]; Arioka, Hitoshi ^[16]; Kudo, Masatoshi ^[17]; Arai, Yasuaki ^[18]

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1. Kitasato University School of Medicine, Department of Gastroenterology, Internal Medicine (Japan)
2. Musashino Red Cross Hospital, Department of Gastroenterology and Hepatology (Japan)
3. Shizuoka Cancer Center, Division of Interventional Radiology (Japan)
4. National Cancer Center Hospital East, Department of Hepatobiliary and Pancreatic Oncology (Japan)
5. Aichi Cancer Center Hospital, Department of Diagnostic and Interventional Radiology (Japan)
6. Osaka International Cancer Institute, Department of Hepatobiliary and Pancreatic Oncology (Japan)
7. National Cancer Center Hospital, Department of Hepatobiliary and Pancreatic Oncology (Japan)
8. Okayama University Medical School, Department of Radiology (Japan)
9. Kanazawa University Hospital, Department of Gastroenterology (Japan)
10. Fukuoka University, Department of Radiology, Faculty of Medicine (Japan)
11. Asahikawa Kosei General Hospital, Department of Radiology (Japan)
12. Kyorin University Faculty of Medicine, Department of Medical Oncology (Japan)
13. Kanazawa University Graduate School of Medical Science, Department of Radiology (Japan)
14. Chiba University, Department of Gastroenterology, Graduate School of Medicine (Japan)
15. Kyoto University Graduate School of Medicine, Department of Biomedical Statistics and Bioinformatics (Japan)
16. Yokohama Rosai Hospital, Department of Medical Oncology (Japan)
17. Kindai University Faculty of Medicine, Department of Gastroenterology and Hepatology (Japan)
18. National Cancer Center Hospital, Department of Diagnostic Radiology (Japan)

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.

• OSTI ID: 22938415
• Journal Information: Medical Oncology (Online), Journal Name: Medical Oncology (Online) Journal Issue: 6 Vol. 36; ISSN 1559-131X
• Country of Publication: United States
• Language: English

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62 RADIOLOGY AND NUCLEAR MEDICINE
COMPARATIVE EVALUATIONS
GROWTH FACTORS
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NEOPLASMS
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SAFETY