PMID- 25655899
OWN - NLM
STAT- MEDLINE
DCOM- 20160302
LR  - 20221207
IS  - 1437-7772 (Electronic)
IS  - 1341-9625 (Print)
IS  - 1341-9625 (Linking)
VI  - 20
IP  - 5
DP  - 2015 Oct
TI  - Regorafenib for advanced gastrointestinal stromal tumors following imatinib and 
      sunitinib treatment: a subgroup analysis evaluating Japanese patients in the 
      phase III GRID trial.
PG  - 905-12
LID - 10.1007/s10147-015-0790-y [doi]
AB  - BACKGROUND: The randomized, double-blind, placebo-controlled GRID trial tested 
      the oral multikinase inhibitor regorafenib in 199 patients with advanced 
      gastrointestinal stromal tumors (GIST) following failure of at least imatinib and 
      sunitinib, and showed a significant improvement in progression-free survival 
      (PFS) versus placebo [hazard ratio (HR) 0.27; 95 % confidence interval (CI) 
      0.19-0.39; p < 0.0001]. METHODS: A subgroup analysis of Japanese patients in the 
      GRID study was performed to compare the efficacy and safety of oral regorafenib 
      160 mg once daily with matching placebo, in combination with best supportive 
      care. The primary study endpoint was progression-free survival (PFS); safety was 
      evaluated through the incidence of adverse events (AEs). RESULTS: Seventeen 
      Japanese patients were randomized to regorafenib (n = 12) or placebo (n = 5). 
      Patient demographics were consistent with those of the overall study population. 
      PFS was significantly longer with regorafenib than placebo (HR 0.08; 95 % CI 
      0.02-0.45; p = 0.000164). Centrally assessed disease control rates were 58 % and 
      20 % in the regorafenib and placebo groups, respectively (p = 0.080796). 
      Treatment-related adverse events (AEs) were reported in all regorafenib-treated 
      patients and 60 % of placebo recipients; the most frequent AE was hand-foot skin 
      reaction (HFSR) (92 % versus 20 %, respectively). CONCLUSION: Regorafenib showed 
      efficacy and a manageable safety profile in Japanese patients with advanced GIST, 
      consistent with the overall GRID study population. AEs, such as HFSR and 
      maculopapular rash, were observed more frequently in Japanese patients. Although 
      dose modification was frequently reported, only one patient with hepatic failure 
      discontinued regorafenib because of AEs.
FAU - Komatsu, Yoshito
AU  - Komatsu Y
AD  - Cancer Center, Hokkaido University Hospital, Kita 14 Nishi 5, Kita-ku, Sapporo, 
      Hokkaido, 060-8648, Japan. ykomatsu@ac.cyberhome.ne.jp.
FAU - Doi, Toshihiko
AU  - Doi T
AD  - National Cancer Center Hospital East, Kashiwa, Japan.
FAU - Sawaki, Akira
AU  - Sawaki A
AD  - Department of Oncology and Gastroenterology, Nagoya Second Red Cross Hospital, 
      Nagoya, Japan.
FAU - Kanda, Tatsuo
AU  - Kanda T
AD  - Division of Digestive and General Surgery, Niigata University Graduate School of 
      Medical and Dental Sciences, Niigata, Japan.
FAU - Yamada, Yasuhide
AU  - Yamada Y
AD  - Gastrointestinal Oncology Division, National Cancer Center Hospital, Tokyo, 
      Japan.
FAU - Kuss, Iris
AU  - Kuss I
AD  - Global Clinical Development, Oncology, Ophthalmology and Neurology, Bayer Pharma 
      AG, Berlin, Germany.
FAU - Demetri, George D
AU  - Demetri GD
AD  - Ludwig Cancer Center, Dana-Farber Cancer Institute, Harvard Medical School, 
      Boston, MA, USA.
FAU - Nishida, Toshirou
AU  - Nishida T
AD  - Department of Surgery, National Cancer Center Hospital East, Kashiwa, Japan.
LA  - eng
SI  - ClinicalTrials.gov/NCT01933958
GR  - P50 CA127003/CA/NCI NIH HHS/United States
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20150206
PL  - Japan
TA  - Int J Clin Oncol
JT  - International journal of clinical oncology
JID - 9616295
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Indoles)
RN  - 0 (Phenylurea Compounds)
RN  - 0 (Pyridines)
RN  - 0 (Pyrroles)
RN  - 24T2A1DOYB (regorafenib)
RN  - 8A1O1M485B (Imatinib Mesylate)
RN  - V99T50803M (Sunitinib)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antineoplastic Agents/*therapeutic use
MH  - Asian People
MH  - Double-Blind Method
MH  - Gastrointestinal Neoplasms/*drug therapy/ethnology/pathology
MH  - Gastrointestinal Stromal Tumors/*drug therapy/ethnology/pathology
MH  - Humans
MH  - Imatinib Mesylate/therapeutic use
MH  - Indoles/therapeutic use
MH  - Middle Aged
MH  - Phenylurea Compounds/*therapeutic use
MH  - Pyridines/*therapeutic use
MH  - Pyrroles/therapeutic use
MH  - Sunitinib
MH  - Survival Analysis
MH  - Young Adult
PMC - PMC4527951
MID - NIHMS665760
OTO - NOTNLM
OT  - Gastrointestinal stromal tumor
OT  - Hand-foot syndrome
OT  - Hypertension
OT  - Japanese
OT  - Regorafenib
EDAT- 2015/02/07 06:00
MHDA- 2016/03/05 06:00
PMCR- 2015/11/01
CRDT- 2015/02/07 06:00
PHST- 2014/10/28 00:00 [received]
PHST- 2015/01/21 00:00 [accepted]
PHST- 2015/02/07 06:00 [entrez]
PHST- 2015/02/07 06:00 [pubmed]
PHST- 2016/03/05 06:00 [medline]
PHST- 2015/11/01 00:00 [pmc-release]
AID - 10.1007/s10147-015-0790-y [pii]
AID - 10.1007/s10147-015-0790-y [doi]
PST - ppublish
SO  - Int J Clin Oncol. 2015 Oct;20(5):905-12. doi: 10.1007/s10147-015-0790-y. Epub 
      2015 Feb 6.