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. 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.
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Authors | Mercedes Salgado Fernández, Maria Teresa Pérez Hoyos, Isabela Díaz de Corcuera, Alba Vidal Arbués, Marta García de la Torre |
Journal | Expert opinion on drug safety
(Expert Opin Drug Saf)
Vol. 14
Issue 8
Pg. 1171-9
(Aug 2015)
ISSN: 1744-764X [Electronic] England |
PMID | 26076885
(Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
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Chemical References |
- Recombinant Fusion Proteins
- aflibercept
- Receptors, Vascular Endothelial Growth Factor
- Leucovorin
- Fluorouracil
- Camptothecin
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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
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