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.

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.

Keywords:

• aflibercept
• colorectal cancer
• FOLFIRI
• metastatic disease
• named patient program
• safety

Acknowledgments

The report has been presented as an abstract (7419) and poster (PE-2) at the SEOM 3d symposium held from 22 to 24 October 2014 in Madrid, Spain.

Declaration of interest

This study was supported by Sanofi. A. Del Campo (Pivotal SL) provided medical writing services and was funded by Sanofi Pharmaceuticals. M Saldago Fernández has taken part in advisory boards for Celgene, Roche and Sanofi. M Garcia de la Torrre and A Vidal Arbues are employees of Sanofi Spain. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

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