title: Aflibercept for metastatic colorectal cancer: safety data from the Spanish named patient program.
abstract: 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.
  
  
  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.
authors.affiliation: Oncología Médica, 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.
authors.forename: Mercedes
authors.initials: M
authors.lastname: Salgado Fernández
authors.forename: Maria Teresa
authors.initials: MT
authors.lastname: Pérez Hoyos
authors.forename: Isabela
authors.initials: I
authors.lastname: Díaz de Corcuera
authors.forename: Alba
authors.initials: A
authors.lastname: Vidal Arbués
authors.forename: Marta
authors.initials: M
authors.lastname: García de la Torre
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D040262:Receptors, Vascular Endothelial Growth Factor / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D011993:Recombinant Fusion Proteins / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D013030:Spain
chemical_list: D011993:Recombinant Fusion Proteins; C533178:aflibercept; D040262:Receptors, Vascular Endothelial Growth Factor; D002955:Leucovorin; D005472:Fluorouracil; D002166:Camptothecin
keywords: FOLFIRI; aflibercept; colorectal cancer; metastatic disease; named patient program; safety