PMID- 21828378
OWN - NLM
STAT- MEDLINE
DCOM- 20120713
LR  - 20200206
IS  - 1569-8041 (Electronic)
IS  - 0923-7534 (Linking)
VI  - 23
IP  - 4
DP  - 2012 Apr
TI  - Cediranib in combination with mFOLFOX6 in Japanese patients with metastatic 
      colorectal cancer: results from the randomised phase II part of a phase I/II 
      study.
PG  - 933-41
LID - 10.1093/annonc/mdr359 [doi]
AB  - BACKGROUND: Colorectal cancer (CRC) is the second most common malignancy in 
      Japan. Treatment with inhibitors of the vascular endothelial growth factor (VEGF) 
      signalling pathway has proven benefit in metastatic CRC. Cediranib is an oral 
      highly potent VEGF signalling inhibitor that inhibits all three VEGF receptors. 
      PATIENTS AND METHODS: In this phase II, double-blind, placebo-controlled study, 
      172 patients with metastatic CRC were randomised to receive once-daily cediranib 
      (20 or 30 mg) or placebo, each combined with modified FOLFOX6 (mFOLFOX6). The 
      primary objective was comparison of progression-free survival (PFS). RESULTS: The 
      comparison of cediranib 20 mg versus placebo met the primary objective of PFS 
      prolongation [hazard ratio = 0.70 (95% confidence interval 0.44-1.11), P = 
      0.167], which met the protocol-defined criterion of P < 0.2. Median PFS was 10.2 
      versus 8.3 months, respectively. The PFS comparison for cediranib 30 mg versus 
      placebo did not meet the criterion. The most common adverse events (AEs) in the 
      cediranib-containing groups were diarrhoea and hypertension. CONCLUSIONS: 
      Cediranib 20 mg plus mFOLFOX6 met the predefined criteria in terms of improved 
      PFS compared with placebo plus mFOLFOX6. Cediranib 20 mg was generally well 
      tolerated and the AE profile was consistent with previous studies.
FAU - Kato, T
AU  - Kato T
AD  - Department of Surgery, Minoh City Hospital, Osaka, Japan.
FAU - Muro, K
AU  - Muro K
FAU - Yamaguchi, K
AU  - Yamaguchi K
FAU - Bando, H
AU  - Bando H
FAU - Hazama, S
AU  - Hazama S
FAU - Amagai, K
AU  - Amagai K
FAU - Baba, H
AU  - Baba H
FAU - Denda, T
AU  - Denda T
FAU - Shi, X
AU  - Shi X
FAU - Fukase, K
AU  - Fukase K
FAU - Skamoto, J
AU  - Skamoto J
FAU - Mishima, H
AU  - Mishima H
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20110809
PL  - England
TA  - Ann Oncol
JT  - Annals of oncology : official journal of the European Society for Medical 
      Oncology
JID - 9007735
RN  - 0 (Organoplatinum Compounds)
RN  - 0 (Quinazolines)
RN  - 0 (Vascular Endothelial Growth Factor A)
RN  - 04ZR38536J (Oxaliplatin)
RN  - NQU9IPY4K9 (cediranib)
RN  - Q573I9DVLP (Leucovorin)
RN  - U3P01618RT (Fluorouracil)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use
MH  - Carcinoma/blood/*drug therapy/mortality/*secondary
MH  - Colorectal Neoplasms/blood/*drug therapy/mortality/*pathology
MH  - Disease-Free Survival
MH  - Double-Blind Method
MH  - Female
MH  - Fluorouracil/administration & dosage
MH  - Humans
MH  - Japan
MH  - Kaplan-Meier Estimate
MH  - Leucovorin/administration & dosage
MH  - Male
MH  - Middle Aged
MH  - Organoplatinum Compounds/administration & dosage
MH  - Oxaliplatin
MH  - Quinazolines/administration & dosage
MH  - Treatment Outcome
MH  - Vascular Endothelial Growth Factor A/blood
EDAT- 2011/08/11 06:00
MHDA- 2012/07/14 06:00
CRDT- 2011/08/11 06:00
PHST- 2011/08/11 06:00 [entrez]
PHST- 2011/08/11 06:00 [pubmed]
PHST- 2012/07/14 06:00 [medline]
AID - S0923-7534(19)34653-8 [pii]
AID - 10.1093/annonc/mdr359 [doi]
PST - ppublish
SO  - Ann Oncol. 2012 Apr;23(4):933-41. doi: 10.1093/annonc/mdr359. Epub 2011 Aug 9.