title: Effectiveness and safety of aflibercept for metastatic colorectal cancer: retrospective review within an early access program in Spain.
abstract: OBJECTIVE
  In the VELOUR study, aflibercept + FOLFIRI regimen resulted in improved survival in metastatic colorectal cancer (mCRC) patients who progressed after oxaliplatin. The use of aflibercept outside the clinical trial framework needs to be further assessed in terms of effectiveness and tolerability.
  
  
  METHODS
  Early access to aflibercept through a named patient programme (NPP) was provided to mCRC patients receiving FOLFIRI as second-line treatment in Spain. The effectiveness of aflibercept was assessed as progression-free survival (PFS) achieved within the NPP population. Post hoc analyses on PFS were done according to certain baseline characteristics (K-RAS mutation, prior targeted therapy) or prognostic factors.
  
  
  RESULTS
  Registries from 71 mCRC patients included in the NPP were reviewed retrospectively. The median age for the NPP population was 64 years (19.7 % aged ≥70 years) and 63.4 % patients had ≥2 metastases. A median PFS of 5.3 months (95 % CI, 3.6-8.5 months) was achieved, which did not depend on K-RAS mutation status or prior targeted therapy received. The risk of progression or death increased in patients with a poor prognosis as per the GERCOR score (performance status [PS] 1-2 and increased baseline lactate dehydrogenase [LDH] level) compared with patients with a good prognosis (PS 0 and normal LDH level) (median PFS: 2.6 vs. 8.3 months, respectively; p = 0.0124). Aflibercept was well tolerated, with a manageable toxicity profile.
  
  
  CONCLUSIONS
  Bearing in mind the differences in sample size, the PFS achieved with the aflibercept + FOLFIRI regimen in the real-life practice setting is comparable to that observed in the clinical trial setting.
authors.affiliation: Medical Oncology Department, Hospital Universitario La Paz, Paseo de la Castellana, 261., 28046, Madrid, Spain. jaimefeliu@hotmail.com.
authors.forename: J
authors.initials: J
authors.lastname: Feliu
authors.affiliation: Medical Oncology Department, Hospital Galdakao-Usansolo, Galdakao, Bizkaia, Spain.
authors.forename: I
authors.initials: I
authors.lastname: Díez de Corcuera
authors.affiliation: Medical Oncology Department, Institut Català d'Oncologia-Hospital Germans Trias i Pujol, Barcelona, Spain.
authors.forename: J L
authors.initials: JL
authors.lastname: Manzano
authors.affiliation: Medical Oncology Department, H Virgen del Rocio, Seville, Spain.
authors.forename: M
authors.initials: M
authors.lastname: Valladares-Ayerbes
authors.affiliation: Medical Oncology Department, Hospital Costa del Sol, Marbella, Málaga, Spain.
authors.forename: J
authors.initials: J
authors.lastname: Alcaide
authors.affiliation: Medical Oncology Department, Hospital General Universitario Morales Meseguer, Murcia, Spain.
authors.forename: T
authors.initials: T
authors.lastname: García García
authors.affiliation: Medical Oncology Department, Complejo Hospitalario de Navarra, Pamplona, Spain.
authors.forename: R
authors.initials: R
authors.lastname: Vera
authors.affiliation: Medical Oncology Department, H. Clínico San Carlos, Madrid, Spain.|Medical Oncology Department, Center Affiliated to the Red Temática de Investigación Cooperativa (RD06/0020/0021), Instituto Carlos III, Spanish Ministry of Science and Innovation, Madrid, Spain.
authors.forename: J
authors.initials: J
authors.lastname: Sastre
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D018450:Disease Progression; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D005500:Follow-Up Studies; D006801:Humans; D000077146:Irinotecan; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000556:secondary; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000556:secondary; D008207:Lymphatic Metastasis; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009367:Neoplasm Staging; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin; D010534:Peritoneal Neoplasms / Q000188:drug therapy* / Q000556:secondary; D011379:Prognosis; D040262:Receptors, Vascular Endothelial Growth Factor / Q000008:administration & dosage; D011993:Recombinant Fusion Proteins / Q000008:administration & dosage; D012189:Retrospective Studies; D013030:Spain; D015996:Survival Rate
chemical_list: D009944:Organoplatinum Compounds; D011993:Recombinant Fusion Proteins; D000077150:Oxaliplatin; C533178:aflibercept; D000077146:Irinotecan; D040262:Receptors, Vascular Endothelial Growth Factor; D005472:Fluorouracil; D002166:Camptothecin
keywords: Aflibercept; FOLFIRI; Metastatic colorectal cancer; Named patient programme; Survival analysis