HOMEPRODUCTSCOMPANYCONTACTFAQResearchDictionaryPharmaSign Up FREE or Login

Aflibercept for metastatic colorectal cancer: safety data from the Spanish named patient program.

AbstractOBJECTIVE:
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.
AuthorsMercedes Salgado Fernández, Maria Teresa Pérez Hoyos, Isabela Díaz de Corcuera, Alba Vidal Arbués, Marta García de la Torre
JournalExpert opinion on drug safety (Expert Opin Drug Saf) Vol. 14 Issue 8 Pg. 1171-9 (Aug 2015) ISSN: 1744-764X [Electronic] England
PMID26076885 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
Chemical References
  • Recombinant Fusion Proteins
  • aflibercept
  • Receptors, Vascular Endothelial Growth Factor
  • Leucovorin
  • Fluorouracil
  • Camptothecin
Topics
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols (administration & dosage, adverse effects, therapeutic use)
  • Camptothecin (administration & dosage, adverse effects, analogs & derivatives, therapeutic use)
  • Colorectal Neoplasms (drug therapy, pathology)
  • Female
  • Fluorouracil (administration & dosage, adverse effects, therapeutic use)
  • Humans
  • Leucovorin (administration & dosage, adverse effects, therapeutic use)
  • Male
  • Middle Aged
  • Neoplasm Metastasis
  • Receptors, Vascular Endothelial Growth Factor (administration & dosage, adverse effects, therapeutic use)
  • Recombinant Fusion Proteins (administration & dosage, adverse effects, therapeutic use)
  • Spain

Join CureHunter, for free Research Interface BASIC access!

Take advantage of free CureHunter research engine access to explore the best drug and treatment options for any disease. Find out why thousands of doctors, pharma researchers and patient activists around the world use CureHunter every day.
Realize the full power of the drug-disease research graph!


Choose Username:
Email:
Password:
Verify Password:
Enter Code Shown: