Analysis of overall survival and safety during the course of the phase III VELOUR trial comparing FOLFIRI and ziv-aflibercept or placebo in mCRC patients who progressed on prior oxaliplatin treatment.

Author:

Ruff Paul1,Lakomy Radek2,Prausová Jana3,Van Hazel Guy A.4,Moiseyenko Vladimir5,McKendrick Joseph6,Boelle Emmanuelle7,Castan Remi7,Macarulla Teresa8,Van Cutsem Eric9

Affiliation:

1. University of Witwatersrand Faculty of Health Sciences, Johannesburg, South Africa

2. Masaryk Memorial Cancer Institute, Brno, Czech Republic

3. University Hospital Motol, Prague, Czech Republic

4. School of Medicine and Pharmacology, University of Western Australia, Perth, Australia

5. N.N. Petrov Research Institute of Oncology, St. Petersburg, Russia

6. Eastern Health, Box Hill Hospital, Box Hill, Australia

7. Sanofi, Vitry-sur-Seine, France

8. Hospital Vall d'Hebron, Barcelona, Spain

9. University Hospitals Leuven, Leuven, Belgium

Abstract

3574 Background: VELOUR, a large, international, randomized, placebo (pbo)-controlled study, compared efficacy and safety of FOLFIRI with ziv-aflibercept (known as aflibercept outside the United States) or with pbo in 1,226 metastatic colorectal cancer patients who received prior oxaliplatin treatment. Ziv-aflibercept demonstrated statistically significant, clinically meaningful improvements in median overall survival (OS) (13.5 vs 12.06 mos; hazard ratio [HR]=0.817, P=0.0032), progression-free survival, and response rate. This analysis estimates treatment effect and safety over time course of the study. Methods: HRs by 6-mo time periods were estimated using piecewise Cox proportional hazard model. NCI-CTCAE v3.0 was used to grade adverse event (AE) severity. Results: HR improved over time (Table), consistent with survival curves that continue to separate past the median time point, indicating that the magnitude of ziv-aflibercept treatment effect continues to increase over time. Incidence of grade 3 AEs (45.1% vs 62.0%) was higher in the ziv-aflibercept/FOLFIRI arm; incidences of grade 4 AEs were 17.4% (pbo) vs 21.4% (ziv-aflibercept). More common AEs only occurred in a small proportion of ziv-aflibercept/FOLFIRI cycles (eg, grade ≥3 hypertension and diarrhea occurred in 3.6% and 2.8% of cycles, respectively). The majority of grade 3/4 AEs occurred in early treatment (first 3-4 cycles). Most patients experienced only a single episode of grade ≥3 AEs with ziv-aflibercept/FOLFIRI. Importantly, AEs in VELOUR did not impact patients’ ability to receive chemotherapy. Conclusions: Treatment with ziv-aflibercept/FOLFIRI showed continuous, consistent improvement in OS over time. While combined grade 3/4 AEs were higher with ziv-aflibercept, AEs occurred early in treatment in a small proportion of total cycles; the majority were single-episode in nature. Clinical trial information: NCT00561470. [Table: see text]

Publisher

American Society of Clinical Oncology (ASCO)

Subject

Cancer Research,Oncology

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