PMID- 28807738
OWN - NLM
STAT- MEDLINE
DCOM- 20190523
LR  - 20190523
IS  - 1879-4076 (Electronic)
IS  - 1879-4068 (Linking)
VI  - 9
IP  - 1
DP  - 2018 Jan
TI  - Observed benefit and safety of aflibercept in elderly patients with metastatic 
      colorectal cancer: An age-based analysis from the randomized placebo-controlled 
      phase III VELOUR trial.
PG  - 32-39
LID - S1879-4068(17)30140-6 [pii]
LID - 10.1016/j.jgo.2017.07.010 [doi]
AB  - OBJECTIVES: Aflibercept (ziv-aflibercept) significantly improves progression-free 
      (PFS) and overall survival (OS) when added to 5-fluorouracil, leucovorin and 
      irinotecan (FOLFIRI), compared with FOLFIRI alone, in patients with metastatic 
      colorectal cancer previously treated with oxaliplatin-based therapy. This subset 
      analysis of the VELOUR study investigates aflibercept plus FOLFIRI versus placebo 
      plus FOLFIRI according to age. METHODS: Efficacy and safety were analyzed by 
      treatment arm and age (>/= or <65years). RESULTS: Overall, 443 patients were 
      >/=65years old (205 in aflibercept arm; 238 in placebo arm) and 783 were <65years 
      old (407 in aflibercept arm; 376 in placebo arm). Median OS was 12.6 versus 
      11.3months (hazard ratio [HR]: 0.85; 95.34% CI 0.68-1.07) in patients >/=65years 
      old and 14.5 versus 12.5months (HR: 0.80; 95.34% CI 0.67-0.95) in those patients 
      <65years old, for patients receiving FOLFIRI plus aflibercept or placebo, 
      respectively. There was no interaction between treatment and age. 
      Treatment-emergent adverse events (AEs) were comparable for patients <65years and 
      >/=65years old. The incidence of grade 3/4 AEs was higher for patients >/=65years old 
      than for those <65years old in both the aflibercept (89.3% versus 80.5%) and 
      placebo (67.4% versus 59.4%) arms. Interaction tests for grade 3/4 antiangiogenic 
      agent-related AEs suggested no heterogeneity between the older and younger 
      patient populations (p>0.1). CONCLUSION: A limited but consistent benefit on both 
      OS and PFS was associated with the addition of aflibercept to FOLFIRI compared 
      with placebo in patients <65 and >/=65years old, with a marked but manageable 
      increase in the toxicity profile in older patients. TRIAL REGISTRATION: 
      clinicaltrials.govNCT00561470.
CI  - Copyright (c) 2017 Elsevier Inc. All rights reserved.
FAU - Ruff, Paul
AU  - Ruff P
AD  - University of Witwatersrand Faculty of Health Sciences, Johannesburg, South 
      Africa. Electronic address: pruff@iafrica.com.
FAU - Van Cutsem, Eric
AU  - Van Cutsem E
AD  - University Hospitals Leuven and KU Leuven, Belgium.
FAU - Lakomy, Radek
AU  - Lakomy R
AD  - Masaryk Memorial Cancer Institute, Brno, Czech Republic.
FAU - Prausova, Jana
AU  - Prausova J
AD  - University Hospital Motol, Prague, Czech Republic.
FAU - van Hazel, Guy A
AU  - van Hazel GA
AD  - University of Western Australia, Western Australia, Australia.
FAU - Moiseyenko, Vladimir M
AU  - Moiseyenko VM
AD  - Cancer Center, St-Petersburg, Russian Federation.
FAU - Soussan-Lazard, Karen
AU  - Soussan-Lazard K
AD  - Sanofi, Vitry-sur-Seine, France.
FAU - Dochy, Emmanuelle
AU  - Dochy E
AD  - Sanofi, Diegem, Belgium.
FAU - Magherini, Emmanuelle
AU  - Magherini E
AD  - Sanofi, Vitry-sur-Seine, France.
FAU - Macarulla, Teresa
AU  - Macarulla T
AD  - Vall d'Hebron University Hospital and Institute of Oncology (VHIO), Barcelona, 
      Spain.
FAU - Papamichael, Demetris
AU  - Papamichael D
AD  - Bank of Cyprus Oncology Centre, Nicosia, Cyprus.
LA  - eng
SI  - ClinicalTrials.gov/NCT00561470
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20170812
PL  - Netherlands
TA  - J Geriatr Oncol
JT  - Journal of geriatric oncology
JID - 101534770
RN  - 0 (Angiogenesis Inhibitors)
RN  - 0 (Recombinant Fusion Proteins)
RN  - 15C2VL427D (aflibercept)
RN  - EC 2.7.10.1 (Receptors, Vascular Endothelial Growth Factor)
RN  - Q573I9DVLP (Leucovorin)
RN  - U3P01618RT (Fluorouracil)
RN  - XT3Z54Z28A (Camptothecin)
RN  - IFL protocol
SB  - IM
MH  - Adenocarcinoma/*drug therapy
MH  - Age Factors
MH  - Aged
MH  - Aged, 80 and over
MH  - Angiogenesis Inhibitors/*administration & dosage/adverse effects
MH  - Antineoplastic Combined Chemotherapy Protocols/*administration & dosage/adverse 
      effects
MH  - Camptothecin/administration & dosage/adverse effects/*analogs & derivatives
MH  - Colorectal Neoplasms/*drug therapy
MH  - Disease-Free Survival
MH  - Double-Blind Method
MH  - Female
MH  - Fluorouracil/administration & dosage/adverse effects
MH  - Humans
MH  - Kaplan-Meier Estimate
MH  - Leucovorin/administration & dosage/adverse effects
MH  - Male
MH  - Middle Aged
MH  - Neoplasm Metastasis
MH  - Receptors, Vascular Endothelial Growth Factor/*administration & dosage
MH  - Recombinant Fusion Proteins/*administration & dosage/adverse effects
OTO - NOTNLM
OT  - Aflibercept
OT  - Elderly
OT  - Second-line
OT  - VEGF-Trap
OT  - VELOUR
OT  - mCRC
EDAT- 2017/08/16 06:00
MHDA- 2019/05/24 06:00
CRDT- 2017/08/16 06:00
PHST- 2017/01/27 00:00 [received]
PHST- 2017/04/27 00:00 [revised]
PHST- 2017/07/26 00:00 [accepted]
PHST- 2017/08/16 06:00 [pubmed]
PHST- 2019/05/24 06:00 [medline]
PHST- 2017/08/16 06:00 [entrez]
AID - S1879-4068(17)30140-6 [pii]
AID - 10.1016/j.jgo.2017.07.010 [doi]
PST - ppublish
SO  - J Geriatr Oncol. 2018 Jan;9(1):32-39. doi: 10.1016/j.jgo.2017.07.010. Epub 2017 
      Aug 12.