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REFLECT-a phase 3 trial comparing efficacy and safety of lenvatinib to sorafenib for the treatment of unresectable hepatocellular carcinoma: an analysis of Japanese subset.

Authors
  • Yamashita, Tatsuya1
  • Kudo, Masatoshi2
  • Ikeda, Kenji3
  • Izumi, Namiki4
  • Tateishi, Ryosuke5
  • Ikeda, Masafumi6
  • Aikata, Hiroshi7
  • Kawaguchi, Yasunori8, 9
  • Wada, Yoshiyuki10
  • Numata, Kazushi11
  • Inaba, Yoshitaka12
  • Kuromatsu, Ryoko13
  • Kobayashi, Masahiro3
  • Okusaka, Takuji14
  • Tamai, Toshiyuki15
  • Kitamura, Chifumi15
  • Saito, Kenichi15
  • Haruna, Katsuya15
  • Okita, Kiwamu16
  • Kumada, Hiromitsu3
  • 1 Department of Gastroenterology, Kanazawa University, Kanazawa, Japan. [email protected] , (Japan)
  • 2 Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka, Japan. , (Japan)
  • 3 Department of Hepatology, Toranomon Hospital, Tokyo, Japan. , (Japan)
  • 4 Department of Gastroenterology and Hepatology, Musashino Red Cross Hospital, Musashino, Japan. , (Japan)
  • 5 Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan. , (Japan)
  • 6 Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Kashiwa, Japan. , (Japan)
  • 7 Department of Gastroenterology and Metabolism, Hiroshima University, Hiroshima, Japan. , (Japan)
  • 8 Department of Hepatobiliary and Pancreatology, Saga-Ken Medical Center Koseikan, Saga, Japan. , (Japan)
  • 9 Department of Gastroenterology, Asakura Medical Association Hospital, Asakura, Japan. , (Japan)
  • 10 Department of Hepato-Biliary-Pancreatic Surgery, Clinical Research Institute, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan. , (Japan)
  • 11 Gastroenterological Center, Yokohama City University Medical Center, Yokohama, Japan. , (Japan)
  • 12 Department of Diagnostic and Interventional Radiology, Aichi Cancer Center Hospital, Nagoya, Japan. , (Japan)
  • 13 Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine, Kurume, Japan. , (Japan)
  • 14 Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan. , (Japan)
  • 15 Eisai Co., Ltd., Tokyo, Japan. , (Japan)
  • 16 Department of Hepatology, Shunan Memorial Hospital, Kudamatsu, Japan. , (Japan)
Type
Published Article
Journal
Journal of gastroenterology
Publication Date
Nov 12, 2019
Identifiers
DOI: 10.1007/s00535-019-01642-1
PMID: 31720835
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

A phase 3, multinational, randomized, non-inferiority trial (REFLECT) compared the efficacy and safety of lenvatinib (LEN) and sorafenib (SOR) in patients with unresectable hepatocellular carcinoma (uHCC). LEN had an effect on overall survival (OS) compared to SOR, statistically confirmed by non-inferiority [OS: median = 13.6 months vs. 12.3 months; hazard ratio (HR) 0.92, 95% confidence interval (CI) 0.79-1.06], and demonstrated statistically significant improvements in progression-free survival (PFS) and the objective response rate (ORR) in the overall population. The results of a subset analysis that evaluated the efficacy and safety of LEN and SOR in the Japanese population are reported. The intent-to-treat population enrolled in Japan was analyzed. Of 954 patients in the overall population, 168 Japanese patients were assigned to the LEN arm (N = 81) or the SOR arm (N = 87). Median OS was 17.6 months for LEN vs. 17.8 months for SOR (HR 0.90; 95% CI 0.62-1.29). LEN showed statistically significant improvements over SOR in PFS (7.2 months vs. 4.6 months) and ORR (29.6% vs. 6.9%). The relative dose intensity of LEN and SOR in the Japanese population was lower than in the overall population. Frequently observed, related adverse events included palmar-plantar erythrodysaesthesia syndrome (PPES), hypertension, decreased appetite, and proteinuria in the LEN arm, and PPES, hypertension, diarrhea, and alopecia in the SOR arm. The efficacy and safety of LEN in the Japanese population were similar to those in the overall population of REFLECT. With manageable adverse events, LEN is a new treatment option for Japanese patients with uHCC. ClinicalTrials.gov. No. NCT01761266.

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