Safety and efficacy of sorafenib in Japanese patients with hepatocellular carcinoma in clinical practice: a subgroup analysis of GIDEON.
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.
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.
Masatoshi
M
Kudo
Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Chiba, Japan.
Masafumi
M
Ikeda
Department of Digestive Surgery, Nihon University School of Medicine, Tokyo, Japan.
Tadatoshi
T
Takayama
Gastroenterological Center, Yokohama City University Medical Center, Kanagawa, Japan.
Kazushi
K
Numata
Department of Gastroenterology and Hepatology, Musashino Red Cross Hospital, Tokyo, Japan.
Namiki
N
Izumi
Department of Internal Medicine, Medical Oncology, School of Medicine, Kyorin University, Tokyo, Japan.
Junji
J
Furuse
Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan.
Takuji
T
Okusaka
Department of Radiology, Shinshu University School of Medicine, Nagano, Japan.
Masumi
M
Kadoya
Medical Affairs Oncology and Hematology, Bayer Yakuhin, Ltd., Osaka, Japan.
Satoshi
S
Yamashita
Medical Affairs Oncology and Hematology, Bayer Yakuhin, Ltd., Osaka, Japan.
Yuichiro
Y
Ito
Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery, Graduate School of Medicine, University of Tokyo, Tokyo, Japan.
Norihiro
N
Kokudo
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy* / Q000473:pathology; D016461:Chemoembolization, Therapeutic / Q000379:methods; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009536:Niacinamide / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D010671:Phenylurea Compounds / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D011358:Product Surveillance, Postmarketing / Q000379:methods; D011446:Prospective Studies; D000077157:Sorafenib; D016896:Treatment Outcome; D055815:Young Adult
D000970:Antineoplastic Agents; D010671:Phenylurea Compounds; D009536:Niacinamide; D000077157:Sorafenib
GIDEON; Hepatocellular carcinoma; Japanese; Sorafenib