A VELOUR post hoc subset analysis: prognostic groups and treatment outcomes in patients with metastatic colorectal cancer treated with aflibercept and FOLFIRIReport as inadecuate

A VELOUR post hoc subset analysis: prognostic groups and treatment outcomes in patients with metastatic colorectal cancer treated with aflibercept and FOLFIRI - Download this document for free, or read online. Document in PDF available to download.

BMC Cancer

, 14:605

Clinical oncology


BackgroundThe VELOUR study demonstrated a survival benefit for FOLFIRI + aflibercept versus FOLFIRI + placebo in metastatic colorectal cancer mCRC patients who progressed on oxaliplatin-based chemotherapy. Continued divergence of overall survival OS curves in the intension to treat ITT population, with the survival advantage persisting beyond median survival time, suggested subpopulations might have different magnitudes of survival gain. Additionally, 10% of patients within VELOUR had recurrence during or within 6 months of completing oxaliplatin-based adjuvant therapy adjuvant fast relapsers - previously identified as having poorer survival outcomes.

MethodsTo determine which patients received the greatest benefit from FOLFIRI-aflibercept, a post hoc multivariate analysis of the VELOUR ITT population was conducted. Prognostic factors identified were applied to the ITT population, excluding adjuvant fast relapsers, to derive OS prognostic profiles.

ResultsThe better efficacy subgroup was identified as patients within VELOUR exclusive of adjuvant fast relapsers and had performance status PS 0 with any number of metastatic site or PS 1 with <2 metastatic site. A significant improvement in efficacy outcome was observed with aflibercept in the better efficacy subgroup. Median OS for FOLFIRI-aflibercept and FOLFIRI-placebo:16.2 and 13.1 months adjusted Hazard Ratio HR = 0.73; 95% confidence interval CI: 0.61–0.86; median progression free survival PFS: 7.2 and 4.8 months adjusted HR = 0.68; 95% CI: 0.57-0.80; and objective response rate ORR: 24% versus 11% respectively. Poorer efficacy subgroup comprised of adjuvant fast relapsers or patients with PS2 or PS1 with ≥2 metastatic sites. In poorer efficacy subgroup, no benefit was seen with aflibercept. Median OS for FOLFIRI-aflibercept and FOLFIRI-placebo: 10.4 and 9.6 months adjusted HR = 0.97; 95% CI: 0.78-1.21 respectively with no improvement in PFS or ORR.

ConclusionThis analysis suggests that within VELOUR, patients in the better efficacy subgroup may derive enhanced benefit from treatment with FOLFIRI-aflibercept. These prognostic criteria may guide practitioners toward optimal use of targeted biologicals in appropriate second-line mCRC patients.

KeywordsAflibercept Metastatic colorectal cancer Chemotherapy Anti-VEGF agents Targeted therapy AbbreviationsAEsAdverse events

CIConfidence interval

CRCColorectal cancer

ECOGEastern Cooperative Oncology Group


HRHazard ratio



mCRCmetastatic colorectal cancer

ORROverall response rate

OSOverall survival

PFSProgression-free survival

PSPerformance status

VEGFVascular endothelial growth factor.

Electronic supplementary materialThe online version of this article doi:10.1186-1471-2407-14-605 contains supplementary material, which is available to authorized users.

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Author: Ian Chau - Florence Joulain - Sheikh Usman Iqbal - John Bridgewater

Source: https://link.springer.com/


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