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         headline:Safety and efficacy of sorafenib in Japanese patients with hepatocellular carcinoma in clinical practice: a subgroup analysis of GIDEON
         description:GIDEON was a prospective, global, non-interventional study evaluating the safety of sorafenib in patients with unresectable hepatocellular carcinoma in real-world practice. The aim of this subgroup analysis was to assess the safety and efficacy of sorafenib as used by Japanese patients. In Japan, 508 patients were valid for safety analysis. Efficacy and safety were evaluated by the Child-Pugh score. The number of patients with Child-Pugh A and B was 432 (85.0 %) and 58 (11.4 %), respectively. The median overall survival time and time to progression in patients with Child-Pugh A and Child-Pugh B were 17.4 and 4.9 months, 3.7 and 2.3 months, respectively. The most common drug-related adverse events (AEs) included hand-foot skin reaction (47.8 %), diarrhea (35.8 %) and hypertension (24.2 %). The incidences of all or drug-related AEs were similar between patients with Child-Pugh A and B. However, all or drug-related serious AEs, AEs resulting in permanent discontinuation of sorafenib and deaths were observed more frequently in patients with Child-Pugh B compared with Child-Pugh A. Duration of treatment tended to be shorter as the Child-Pugh score worsened. Sorafenib was well tolerated by Japanese HCC patients in clinical settings. Patients with Child-Pugh B had shorter duration of treatment and higher incidence of SAEs. It is important to carefully evaluate patients’ conditions and assess the benefit and risk before making a decision to treat patients with sorafenib.
         datePublished:2016-04-22T00:00:00Z
         dateModified:2016-04-22T00:00:00Z
         pageStart:1150
         pageEnd:1160
         license:http://creativecommons.org/licenses/by/4.0/
         sameAs:https://doi.org/10.1007/s00535-016-1204-2
         keywords:
            Hepatocellular carcinoma
            Sorafenib
            Japanese
            GIDEON
            Gastroenterology
            Hepatology
            Abdominal Surgery
            Colorectal Surgery
            Surgical Oncology
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      headline:Safety and efficacy of sorafenib in Japanese patients with hepatocellular carcinoma in clinical practice: a subgroup analysis of GIDEON
      description:GIDEON was a prospective, global, non-interventional study evaluating the safety of sorafenib in patients with unresectable hepatocellular carcinoma in real-world practice. The aim of this subgroup analysis was to assess the safety and efficacy of sorafenib as used by Japanese patients. In Japan, 508 patients were valid for safety analysis. Efficacy and safety were evaluated by the Child-Pugh score. The number of patients with Child-Pugh A and B was 432 (85.0 %) and 58 (11.4 %), respectively. The median overall survival time and time to progression in patients with Child-Pugh A and Child-Pugh B were 17.4 and 4.9 months, 3.7 and 2.3 months, respectively. The most common drug-related adverse events (AEs) included hand-foot skin reaction (47.8 %), diarrhea (35.8 %) and hypertension (24.2 %). The incidences of all or drug-related AEs were similar between patients with Child-Pugh A and B. However, all or drug-related serious AEs, AEs resulting in permanent discontinuation of sorafenib and deaths were observed more frequently in patients with Child-Pugh B compared with Child-Pugh A. Duration of treatment tended to be shorter as the Child-Pugh score worsened. Sorafenib was well tolerated by Japanese HCC patients in clinical settings. Patients with Child-Pugh B had shorter duration of treatment and higher incidence of SAEs. It is important to carefully evaluate patients’ conditions and assess the benefit and risk before making a decision to treat patients with sorafenib.
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      dateModified:2016-04-22T00:00:00Z
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         Hepatocellular carcinoma
         Sorafenib
         Japanese
         GIDEON
         Gastroenterology
         Hepatology
         Abdominal Surgery
         Colorectal Surgery
         Surgical Oncology
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      name:Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Chiba, Japan
      name:Department of Digestive Surgery, Nihon University School of Medicine, Tokyo, Japan
      name:Gastroenterological Center, Yokohama City University Medical Center, Kanagawa, Japan
      name:Department of Gastroenterology and Hepatology, Musashino Red Cross Hospital, Tokyo, Japan
      name:Department of Internal Medicine, Medical Oncology, School of Medicine, Kyorin University, Tokyo, Japan
      name:Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan
      name:Department of Radiology, Shinshu University School of Medicine, Nagano, Japan
      name:Medical Affairs Oncology and Hematology, Bayer Yakuhin, Ltd., Osaka, Japan
      name:Medical Affairs Oncology and Hematology, Bayer Yakuhin, Ltd., Osaka, Japan
      name:Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery, Graduate School of Medicine, University of Tokyo, Tokyo, Japan

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