PMID- 26076885
OWN - NLM
STAT- MEDLINE
DCOM- 20160321
LR  - 20150718
IS  - 1744-764X (Electronic)
IS  - 1474-0338 (Linking)
VI  - 14
IP  - 8
DP  - 2015 Aug
TI  - Aflibercept for metastatic colorectal cancer: safety data from the Spanish named 
      patient program.
PG  - 1171-9
LID - 10.1517/14740338.2015.1057495 [doi]
AB  - OBJECTIVE: Aflibercept increased overall survival with acceptable tolerability in 
      metastatic colorectal cancer (mCRC) when it was used in combination with FOLFIRI 
      after progression on a first-line oxaliplatin regimen (VELOUR study). The safety 
      profile of aflibercept in day-to-day clinical practice was assessed. DESIGN AND 
      METHODS: A named patient program provided early access to aflibercept to mCRC 
      patients in Spain before its commercialization. Patients received aflibercept 4 
      mg/kg intravenous + FOLFIRI every 2 weeks as second-line treatment. A descriptive 
      safety analysis was conducted. RESULTS: Data from 89 mCRC patients were analyzed 
      (male: 61.8%; median age: 62 years [interquartile range: 55, 67]; Eastern 
      Cooperative Oncology Group 0 - 1: 95.5%). Fifty four (60.7%) patients presented >/= 
      2 metastasis [liver (83.1%), lung (44.9%) or lymph nodes (33.7%)]. Most patients 
      had previously received bevacizumab (60.7%) or anti-EGFR (19.1%) therapy. 
      Patients received a median of 6.0 (interquartile range: 4, 13) cycles of FOLFIRI 
      + aflibercept. Most grade >/= 3 adverse events (AEs) were reported during the 
      initial cycles of treatment. AEs possibly related to treatment occurred in 39 
      (43.8%) patients. Common grade >/= 3 treatment-related AEs were neutropenia (7.9%), 
      diarrhea (4.5%) and hypertension (3.4%). CONCLUSIONS: In clinical practice, 
      aflibercept + FOLFIRI is well tolerated, with a manageable toxicity profile. The 
      safety results confirm the findings from the confirmatory VELOUR trial.
FAU - Salgado Fernandez, Mercedes
AU  - Salgado Fernandez M
AD  - Oncologia Medica, Complexo Hospitalario Universitario de Ourense, C/Ramon Puga 
      Noguerol , 52-54, 32005 Ourense , Spain +34 9 8838 5471 ; +34 9 8838 5398 ; 
      mercedes.salgado.fernandez@sergas.es.
FAU - Perez Hoyos, Maria Teresa
AU  - Perez Hoyos MT
FAU - Diaz de Corcuera, Isabela
AU  - Diaz de Corcuera I
FAU - Vidal Arbues, Alba
AU  - Vidal Arbues A
FAU - Garcia de la Torre, Marta
AU  - Garcia de la Torre M
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20150616
PL  - England
TA  - Expert Opin Drug Saf
JT  - Expert opinion on drug safety
JID - 101163027
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  - Aged
MH  - Antineoplastic Combined Chemotherapy Protocols/administration & dosage/*adverse 
      effects/therapeutic use
MH  - Camptothecin/administration & dosage/adverse effects/*analogs & 
      derivatives/therapeutic use
MH  - Colorectal Neoplasms/*drug therapy/pathology
MH  - Female
MH  - Fluorouracil/administration & dosage/adverse effects/therapeutic use
MH  - Humans
MH  - Leucovorin/administration & dosage/adverse effects/therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Neoplasm Metastasis
MH  - Receptors, Vascular Endothelial Growth Factor/administration & dosage/*adverse 
      effects/therapeutic use
MH  - Recombinant Fusion Proteins/administration & dosage/*adverse effects/therapeutic 
      use
MH  - Spain
OTO - NOTNLM
OT  - FOLFIRI
OT  - aflibercept
OT  - colorectal cancer
OT  - metastatic disease
OT  - named patient program
OT  - safety
EDAT- 2015/06/17 06:00
MHDA- 2016/03/22 06:00
CRDT- 2015/06/17 06:00
PHST- 2015/06/17 06:00 [entrez]
PHST- 2015/06/17 06:00 [pubmed]
PHST- 2016/03/22 06:00 [medline]
AID - 10.1517/14740338.2015.1057495 [doi]
PST - ppublish
SO  - Expert Opin Drug Saf. 2015 Aug;14(8):1171-9. doi: 10.1517/14740338.2015.1057495. 
      Epub 2015 Jun 16.