PMID- 29383843
OWN - NLM
STAT- MEDLINE
DCOM- 20180724
LR  - 20181202
IS  - 1743-7563 (Electronic)
IS  - 1743-7555 (Linking)
VI  - 14
IP  - 3
DP  - 2018 Jun
TI  - Efficacy and safety of sunitinib alternate day regimen in patients with 
      metastatic renal cell carcinoma in Japan: Comparison with standard 4/2 schedule.
PG  - 153-158
LID - 10.1111/ajco.12849 [doi]
AB  - AIM: Sunitinib is a standard agent for metastatic renal cell carcinoma (mRCC). 
      The standard schedule, 4 weeks-on followed by 2 weeks-off (4/2 schedule), often 
      does not maintain an adequate dosage because of the severe adverse events (AEs). 
      We compared the efficacy and safety of an alternative every other day (q.a.d.) 
      dosing with that of the 4/2 schedule in mRCC patients. METHODS: Of the 55 
      Japanese patients, 32 and 23 were administered 4/2 (standard group) and q.a.d. 
      schedules (50 or 37.5 mg, every other day; experimental groups), respectively. 
      The AEs, anticancer effects, and trough plasma concentrations of sunitinib were 
      compared between them. RESULTS: The most common AE in the standard group was 
      thrombocytopenia (43.2%), but it was observed in only two patients in the 
      experimental group (8.7%). Although leukopenia and hand-foot syndrome were both 
      detected in six patients (18.8%) in the standard group, no patients had these AEs 
      in the experimental group. The incidence of dose interruption in the experimental 
      group (21.7%) was significantly lower than that in the standard group was (59.4%, 
      P = 0.005). Time to progression (TTP) and overall survival (OS) of the 
      experimental group were better than those of the standard group (P < 0.001 and P 
      = 0.002, respectively). Mean plasma levels in the experimental group (64.83 
      ng/mL) were significantly lower than those in the standard group (135.82 ng/mL, P 
      < 0.001) were. CONCLUSION: Sunitinib administered q.a.d. was safe and effective 
      for mRCC patients. We speculate that the persistent optimal drug plasma 
      concentrations contributed to these effects.
CI  - (c) 2018 The Authors. Asia-Pacific Journal of Clinical Oncology Published by John 
      Wiley & Sons Australia, Ltd.
FAU - Ohba, Kojiro
AU  - Ohba K
AD  - Department of Urology, Nagasaki University Graduate School of Biomedical 
      Sciences, Nagasaki, Japan.
FAU - Miyata, Yasuyoshi
AU  - Miyata Y
AUID- ORCID: 0000-0001-6272-6657
AD  - Department of Urology, Nagasaki University Graduate School of Biomedical 
      Sciences, Nagasaki, Japan.
FAU - Yasuda, Takuji
AU  - Yasuda T
AD  - Department of Urology, Nagasaki University Graduate School of Biomedical 
      Sciences, Nagasaki, Japan.
FAU - Asai, Akihiro
AU  - Asai A
AD  - Department of Urology, The Japanese Red Cross Nagasaki Genbaku Hospital, 
      Nagasaki, Japan.
FAU - Mitsunari, Kensuke
AU  - Mitsunari K
AD  - Department of Urology, Sasebo City General Hospital, Nagasaki, Japan.
FAU - Matsuo, Tomohiro
AU  - Matsuo T
AD  - Department of Urology, Nagasaki University Graduate School of Biomedical 
      Sciences, Nagasaki, Japan.
FAU - Mochizuki, Yasushi
AU  - Mochizuki Y
AD  - Department of Urology, Nagasaki University Graduate School of Biomedical 
      Sciences, Nagasaki, Japan.
FAU - Matsunaga, Noriko
AU  - Matsunaga N
AD  - Department of Hospital Pharmacy, Nagasaki University Hospital, Nagasaki, Japan.
FAU - Sakai, Hideki
AU  - Sakai H
AD  - Department of Urology, Nagasaki University Graduate School of Biomedical 
      Sciences, Nagasaki, Japan.
LA  - eng
PT  - Journal Article
DEP - 20180131
PL  - Australia
TA  - Asia Pac J Clin Oncol
JT  - Asia-Pacific journal of clinical oncology
JID - 101241430
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Indoles)
RN  - 0 (Pyrroles)
RN  - V99T50803M (Sunitinib)
SB  - IM
MH  - Antineoplastic Agents/pharmacology/*therapeutic use
MH  - Carcinoma, Renal Cell/*drug therapy/pathology
MH  - Female
MH  - Humans
MH  - Indoles/administration & dosage/pharmacology/*therapeutic use
MH  - Japan
MH  - Kidney Neoplasms/*drug therapy/pathology
MH  - Male
MH  - Middle Aged
MH  - Neoplasm Metastasis
MH  - Pyrroles/administration & dosage/pharmacology/*therapeutic use
MH  - Sunitinib
OTO - NOTNLM
OT  - alternative sunitinib regimen
OT  - plasma concentration
OT  - prognosis
OT  - renal cell carcinoma
OT  - safety
EDAT- 2018/02/01 06:00
MHDA- 2018/07/25 06:00
CRDT- 2018/02/01 06:00
PHST- 2017/06/10 00:00 [received]
PHST- 2017/11/18 00:00 [accepted]
PHST- 2018/02/01 06:00 [pubmed]
PHST- 2018/07/25 06:00 [medline]
PHST- 2018/02/01 06:00 [entrez]
AID - 10.1111/ajco.12849 [doi]
PST - ppublish
SO  - Asia Pac J Clin Oncol. 2018 Jun;14(3):153-158. doi: 10.1111/ajco.12849. Epub 2018 
      Jan 31.