PMID- 26931117
OWN - NLM
STAT- MEDLINE
DCOM- 20170711
LR  - 20220408
IS  - 1435-5922 (Electronic)
IS  - 0944-1174 (Print)
IS  - 0944-1174 (Linking)
VI  - 51
IP  - 10
DP  - 2016 Oct
TI  - Safety and effectiveness of sorafenib in Japanese patients with hepatocellular 
      carcinoma in daily medical practice: interim analysis of a prospective 
      postmarketing all-patient surveillance study.
PG  - 1011-21
LID - 10.1007/s00535-016-1173-5 [doi]
AB  - BACKGROUND: Sorafenib was approved for treatment of unresectable hepatocellular 
      carcinoma (HCC) in Japan in 2009. A prospective postmarketing all-patient 
      surveillance (PMS) study was requested by Japanese authorities to confirm safety 
      and effectiveness of sorafenib in Japanese HCC population. METHODS: Patients with 
      unresectable HCC treated with sorafenib were followed up for 12 months. Data on 
      patient demographic characteristics, treatment status, clinical outcome, and 
      adverse events (AEs) were collected. RESULTS: This interim analysis included 1109 
      and 1065 patients evaluable for safety and effectiveness, respectively. Most 
      patients (83.4 %) received the recommended initial dose of 400 mg twice daily. 
      After a follow-up of 12-months, 89.8 % had discontinued treatment, most because 
      of AEs (44.5 %) or progression (33.8 %). The most common drug-related adverse 
      events (DRAE) were hand-foot skin reaction (51.4 %), liver dysfunction (26.4 %), 
      diarrhea (25.1 %), and hypertension (21.6 %). The median overall survival (OS) 
      was 348 days [95 % confidence interval (CI) 299-389 days], and the median 
      duration of treatment was 87 days (95 % CI 78-98 days). Multivariate analyses 
      identified baseline prognostic factors for longer OS, including female sex, low 
      Child-Pugh score, Eastern Cooperative Oncology Group performance status 0, tumor 
      stage I/II/III, low aspartate aminotransferase level, high hemoglobin level, 
      hepatitis C and history of surgical resection. CONCLUSIONS: In general, the 
      safety and effectiveness findings in this PMS were consistent with findings from 
      previous clinical studies. Sorafenib was well tolerated and clinically useful for 
      Japanese patients. CLINICAL TRIAL REGISTRATION NUMBER: NCT01411436.
FAU - Kaneko, Shuichi
AU  - Kaneko S
AD  - Disease Control and Homeostasis, Kanazawa University Graduate School of Medical 
      Science, 13-1 Takara-machi, Kanazawa, Ishikawa, 920-8641, Japan. 
      skaneko@m-kanazawa.jp.
FAU - Ikeda, Kenji
AU  - Ikeda K
AD  - Department of Hepatology, Toranomon Hospital, Tokyo, Japan.
FAU - Matsuzaki, Yasushi
AU  - Matsuzaki Y
AD  - Division of Gastroenterology and Hepatology, Department of Internal Medicine, 
      Tokyo Medical University Ibaraki Medical Center, Ibaraki, Japan.
FAU - Furuse, Junji
AU  - Furuse J
AD  - Department of Medical Oncology, Kyorin University School of Medicine, Tokyo, 
      Japan.
FAU - Minami, Hironobu
AU  - Minami H
AD  - Division of Medical Oncology/Hematology, Department of Medicine, Kobe University 
      Graduate School of Medicine, Kobe, Hyogo, Japan.
FAU - Okayama, Yutaka
AU  - Okayama Y
AD  - Pharmacovigilance, Medical Affairs, Bayer Yakuhin, Ltd., Osaka, Japan.
FAU - Sunaya, Toshiyuki
AU  - Sunaya T
AD  - Clinical Statistics, Product Development, Bayer Yakuhin, Ltd., Osaka, Japan.
FAU - Ito, Yuichiro
AU  - Ito Y
AD  - Medical Affairs Oncology and Hematology, Bayer Yakuhin, Ltd., Osaka, Japan.
FAU - Inuyama, Lyo
AU  - Inuyama L
AD  - Pharmacovigilance, Medical Affairs, Bayer Yakuhin, Ltd., Osaka, Japan.
FAU - Okita, Kiwamu
AU  - Okita K
AD  - Shimonoseki Kosei Hospital, Yamaguchi, Japan.
LA  - eng
SI  - ClinicalTrials.gov/NCT01411436
PT  - Journal Article
DEP - 20160301
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/adverse effects/*therapeutic use
MH  - Carcinoma, Hepatocellular/*drug therapy/pathology
MH  - Chemical and Drug Induced Liver Injury/etiology
MH  - Child
MH  - Diarrhea/chemically induced
MH  - Disease Progression
MH  - Female
MH  - Follow-Up Studies
MH  - Hand-Foot Syndrome/etiology
MH  - Humans
MH  - Hypertension/chemically induced
MH  - Japan
MH  - Liver Neoplasms/*drug therapy/pathology
MH  - Male
MH  - Middle Aged
MH  - Neoplasm Staging
MH  - Niacinamide/adverse effects/*analogs & derivatives/therapeutic use
MH  - Patient Acuity
MH  - Phenylurea Compounds/adverse effects/*therapeutic use
MH  - Product Surveillance, Postmarketing
MH  - Prospective Studies
MH  - Sex Factors
MH  - Sorafenib
MH  - Survival Rate
MH  - Withholding Treatment
MH  - Young Adult
PMC - PMC5037148
OTO - NOTNLM
OT  - Hepatocellular carcinoma
OT  - Japanese
OT  - Molecular targeted therapy
OT  - Postmarketing surveillance
OT  - Sorafenib
COIS- Compliance with ethical standard Conflict of interest Shuichi Kaneko has received 
      research grants from Bayer Yakuhin and Nippon Shinyaku, and grants from Chugai 
      Pharmaceutical, MSD, Kowa, Mitsubishi Tanabe Pharma, Bristol-Myers Squibb, Eli 
      Lilly, Boehringer Ingelheim Japan, Kyowa Hakko Kirin, Sumitomo Dainippon Pharma, 
      Takeda Pharmaceutical, Eisai, Daiichi Sankyo, AstraZeneca, Novartis Pharma, 
      Astellas Pharma, Teijin Pharma, Zeria Pharmaceutical, Sanofi, Toray Industries, 
      Shionogi, Novo Nordisk Pharma, and Pfizer Japan. Kenji Ikeda has received lecture 
      fees from Sumitomo Dainippon Pharma and Eisai. Yasushi Matsuzaki has received 
      research grants from Mitsubishi Tanabe Pharma, MSD, Ajinomoto Pharmaceuticals, 
      Eisai, Sumitomo Dainippon Pharma, AbbVie, Daiichi Sankyo, Toray Industries, 
      Minophagen Pharmaceutical, Otsuka Pharmaceutical and Kyowa Hakko Kirin, and 
      lecture fees from Mitsubishi Tanabe Pharma, MSD, Ajinomoto Pharmaceuticals, 
      Bristol-Myers Squibb and Janssen Pharmaceutical. Junji Furuse has received 
      research grants from Taiho Pharma, Ono Pharmaceutical, OncoTherapy Science, Merck 
      Serono, Zeria Pharmaceutical, Eli Lilly Japan, Takeda Pharmaceutical, Chugai 
      Pharmaceutical, Bayer Yakuhin, GlaxoSmithKline and Yakult, and lecture fees from 
      Taiho Pharma, Chugai Pharmaceutical, Yakult and Kyowa Hakko Kirin. Hironobu 
      Minami has received research grants from Kyowa Hakko Kirin, Chugai 
      Pharmaceutical, Taiho Pharma and Bristol-Myers Squibb. Yutaka Okayama, Toshiyuki 
      Sunaya, Yuichiro Ito and Lyo Inuyama are employees of Bayer Yakuhin, Ltd. The 
      other authors declare that they have no conflicts of interest.
EDAT- 2016/03/05 06:00
MHDA- 2017/07/14 06:00
PMCR- 2016/03/01
CRDT- 2016/03/03 06:00
PHST- 2015/12/07 00:00 [received]
PHST- 2016/01/18 00:00 [accepted]
PHST- 2016/03/03 06:00 [entrez]
PHST- 2016/03/05 06:00 [pubmed]
PHST- 2017/07/14 06:00 [medline]
PHST- 2016/03/01 00:00 [pmc-release]
AID - 10.1007/s00535-016-1173-5 [pii]
AID - 1173 [pii]
AID - 10.1007/s00535-016-1173-5 [doi]
PST - ppublish
SO  - J Gastroenterol. 2016 Oct;51(10):1011-21. doi: 10.1007/s00535-016-1173-5. Epub 
      2016 Mar 1.