PMID- 27106231 OWN - NLM STAT- MEDLINE DCOM- 20170531 LR - 20220419 IS - 1435-5922 (Electronic) IS - 0944-1174 (Print) IS - 0944-1174 (Linking) VI - 51 IP - 12 DP - 2016 Dec TI - Safety and efficacy of sorafenib in Japanese patients with hepatocellular carcinoma in clinical practice: a subgroup analysis of GIDEON. PG - 1150-1160 AB - BACKGROUND: 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. METHODS: In Japan, 508 patients were valid for safety analysis. Efficacy and safety were evaluated by the Child-Pugh score. RESULTS: 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. CONCLUSIONS: 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. FAU - Kudo, Masatoshi AU - Kudo M AD - Department of Gastroenterology and Hepatology, Kinki University School of Medicine, 377-2 Ohno-Higashi, Osaka-Sayama, Osaka, 589-8511, Japan. m-kudo@med.kindai.ac.jp. FAU - Ikeda, Masafumi AU - Ikeda M AD - Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Chiba, Japan. FAU - Takayama, Tadatoshi AU - Takayama T AD - Department of Digestive Surgery, Nihon University School of Medicine, Tokyo, Japan. FAU - Numata, Kazushi AU - Numata K AD - Gastroenterological Center, Yokohama City University Medical Center, Kanagawa, Japan. FAU - Izumi, Namiki AU - Izumi N AD - Department of Gastroenterology and Hepatology, Musashino Red Cross Hospital, Tokyo, Japan. FAU - Furuse, Junji AU - Furuse J AD - Department of Internal Medicine, Medical Oncology, School of Medicine, Kyorin University, Tokyo, Japan. FAU - Okusaka, Takuji AU - Okusaka T AD - Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan. FAU - Kadoya, Masumi AU - Kadoya M AD - Department of Radiology, Shinshu University School of Medicine, Nagano, Japan. FAU - Yamashita, Satoshi AU - Yamashita S AD - Medical Affairs Oncology and Hematology, Bayer Yakuhin, Ltd., Osaka, Japan. FAU - Ito, Yuichiro AU - Ito Y AD - Medical Affairs Oncology and Hematology, Bayer Yakuhin, Ltd., Osaka, Japan. FAU - Kokudo, Norihiro AU - Kokudo N AD - Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery, Graduate School of Medicine, University of Tokyo, Tokyo, Japan. LA - eng PT - Journal Article PT - Multicenter Study PT - Observational Study DEP - 20160422 PL - Japan TA - J Gastroenterol JT - Journal of gastroenterology JID - 9430794 RN - 0 (Antineoplastic Agents) RN - 0 (Phenylurea Compounds) RN - 25X51I8RD4 (Niacinamide) RN - 9ZOQ3TZI87 (Sorafenib) SB - IM MH - Adolescent MH - Adult MH - Aged MH - Aged, 80 and over MH - Antineoplastic Agents/administration & dosage/*adverse effects/therapeutic use MH - Carcinoma, Hepatocellular/*drug therapy/pathology MH - Chemoembolization, Therapeutic/methods MH - Dose-Response Relationship, Drug MH - Female MH - Humans MH - Kaplan-Meier Estimate MH - Liver Neoplasms/*drug therapy/pathology MH - Male MH - Middle Aged MH - Neoplasm Staging MH - Niacinamide/administration & dosage/adverse effects/*analogs & derivatives/therapeutic use MH - Phenylurea Compounds/administration & dosage/*adverse effects/therapeutic use MH - Product Surveillance, Postmarketing/methods MH - Prospective Studies MH - Sorafenib MH - Treatment Outcome MH - Young Adult PMC - PMC5121182 OTO - NOTNLM OT - GIDEON OT - Hepatocellular carcinoma OT - Japanese OT - Sorafenib COIS- Kudo has received lecture fees from Bayer Yakuhin, Kowa and Taiho Pharma, and grants from Chugai Pharmaceutical, Otsuka Pharmaceutical, Takeda Pharmaceutical, Taiho Pharma, Sumitomo Dainippon Pharma, Daiichi Sankyo, MSD and Eisai. Ikeda has received lecture fees from Bayer Yakuhin, and research grants from Bayer Yakuhin, Merck Serono, Kyowa Hakko Kirin, Yakult, Taiho Pharma, Eli Lilly Japan, Boehringer Ingelheim, Kowa, Ono Pharmaceutical, Eisai, AstraZeneca, GlaxoSmithKline and Zeria Pharmaceutical. Izumi has received lecture fees from Gilead Sciences, Otsuka Pharmaceutical, Bristol-Myers Squibb and Bayer Yakuhin. Furuse has received research grants from Taiho Pharma, Merck Serono, Zeria Pharmaceutical, Eli Lilly Japan, Janssen Pharmaceutical, Daiichi Sankyo, Sumitomo Dainippon Pharma and J-Pharma, and lecture fees from Taiho Pharma and Yakult. Okusaka has received research grants from Chugai Pharmaceutical, Eli Lilly Japan, Eisai, Novartis Pharma, Takeda Pharmaceutical, Yakult, OncoTherapy Science, Taiho Pharma, Boehringer Ingelheim Japan, Kowa, Kyowa Hakko Kirin, Merck Serono, Ono Pharmaceutical, Pfizer Japan, AstraZeneca, Sumitomo Dainippon Pharma, Zeria Pharmaceutical and GlaxoSmithKline. Kokudo has received research grants from Sumitomo Dainippon Pharma and Taiho Pharma. Yamashita and Ito are employees of Bayer Yakuhin, Ltd. The other authors declare that they have no conflicts of interest. EDAT- 2016/04/24 06:00 MHDA- 2017/06/01 06:00 PMCR- 2016/04/22 CRDT- 2016/04/24 06:00 PHST- 2016/02/24 00:00 [received] PHST- 2016/03/24 00:00 [accepted] PHST- 2016/04/24 06:00 [pubmed] PHST- 2017/06/01 06:00 [medline] PHST- 2016/04/24 06:00 [entrez] PHST- 2016/04/22 00:00 [pmc-release] AID - 10.1007/s00535-016-1204-2 [pii] AID - 1204 [pii] AID - 10.1007/s00535-016-1204-2 [doi] PST - ppublish SO - J Gastroenterol. 2016 Dec;51(12):1150-1160. doi: 10.1007/s00535-016-1204-2. Epub 2016 Apr 22.