529P - Quality of life (QoL) on the aflibercept/FOLFIRI regimen: 4th interim analysis of the global aflibercept safety and health-related QoL program

Date 29 September 2014
Event ESMO 2014
Session Poster Display session
Topics Anti-Cancer Agents & Biologic Therapy
Colon Cancer
Rectal Cancer
Presenter Julien Taieb
Citation Annals of Oncology (2014) 25 (suppl_4): iv167-iv209. 10.1093/annonc/mdu333
Authors J. Taieb1, R. Bordonaro2, K. Bencardino3, L. Ciuffreda4, F. Di Costanzo5, M. Di Bartolomeo6, A.L. Thomas7, H. Kröning8, P. García Alfonso9, C. Borg10, Y. Moore11, S. Brette12, C. Zilocchi13, F. Joulain14, S. Naoshy15, P. Garreau-Laporte16, E. Dochy17, G. Lledo18, A. Sobrero19
  • 1Gi Oncology, APHP and Paris Descartes University, 75006 - Paris/FR
  • 2Medical Oncology, ARNAS Garibaldi Catania, Catania/IT
  • 3Oncology, Ospedale Niguarda Ca' Granda, Milano/IT
  • 4S.c. Oncologia Medica 1, A.O. Citta' della Salute e della Scienza di Torino, Torino/IT
  • 5Sc Oncologia Medica 1, Azienda Ospedaliero Universitaria Careggi, Firenze/IT
  • 6Oncologia Medica 1, Fondazione IRCCS - Istituto Nazionale dei Tumori, Milano/IT
  • 7Cancer Studies And Molecular Medicine, University of Leicester, Leicester/GB
  • 8Oncology, Schwerpunktpraxis für Hämatologie und Onkologie, Magdeburg/DE
  • 9Medical Oncology, Hospital Universitario Gregorio Marañon, Madrid/ES
  • 10Medical Oncology, University Hospital Besançon, Besançon/FR
  • 11Oncology Gma, Sanofi, Cambridge/US
  • 12Clinical Sciences And Operations – Biostatistics For Gma, Lincoln, Boulogne/FR
  • 13Medical Oncology, Sanofi, Milan/IT
  • 14Global Evidence And Value Development, Sanofi, Chilly Mazarin/FR
  • 15Evidence And Value Development, Sanofi, Cambridge/US
  • 16Clinical Trial Operations, Sanofi, Chilly Mazarin/FR
  • 17Oncology Gma, Sanofi, Diegem/BE
  • 18Gastroenterology, Hôpital privé Jean Mermoz, LYON/FR
  • 19Oncologia Medica, IRCCS San Martino, Genova/IT

Abstract

Aim

In the phase 3 VELOUR trial, aflibercept (ziv-aflibercept in the United States) + FOLFIRI significantly improved overall survival vs FOLFIRI alone in metastatic colorectal cancer (mCRC) patients (pts) previously treated with an oxaliplatin-containing regimen. Results of VELOUR supported initiation of the global Aflibercept Safety and QoL Program, comprising 2 clinical studies (ASQoP [NCT01571284]; AFEQT [NCT01670721]) that capture utility values derived from QoL instruments and additional safety data from a population similar to that of VELOUR in a real-life setting. We report QoL and utility value data from the 4th interim analysis of the ASQoP/AFEQT studies.

Methods

Target recruitment in ASQoP is 900 pts from 150 multiple country sites, and 200 pts from French sites for AFEQT. The EuroQoL EQ-5D™ instrument served as the utility measure and the EORTC QLQ-C30 as the generic cancer instrument. QoL populations were pts evaluable for the respective questionnaire at baseline and ≥1 assessment post-baseline and received ≥1 part of 1 dose of study treatment. Both instruments were self-administered at baseline and the beginning of every odd treatment cycle. Four preplanned interim analyses were conducted.

Results

At the 4th interim analysis cutoff date, the EQ-5D population comprised 523 pts; 57.6% men, median age 62 years (range 20-89), 65.4% had Eastern Cooperative Oncology Group scores = 0. Mean baseline utility index was 0.77 (95% CI, 0.75-0.79). Utility index remained relatively stable at cycle 3 (in 449 evaluable pts) and up to cycle 17 (in 33 evaluable pts) with a mean (±SD) change from baseline of -0.02 (±0.24) and -0.08 (±0.19), respectively. Mean baseline global health status (GHS) score from EORTC QLQ-C30 was 68.44 (95% CI, 66.68-70.21) and remained in the stable range across subsequent cycles for both GHS and functional scales.

Conclusions

Trends from this interim analysis suggest relatively stable utility and QoL scores in mCRC pts treated in second line with aflibercept + FOLFIRI. This has important implications in advanced cancer, as patient-reported outcomes provide an important, real-world perspective on health status and well-being.

Disclosure

J. Taieb: has disclosures relating to participation in advisory boards for Sanofi and corporate-sponsored research for Sanofi;P. García Alfonso: has disclosures related to participating in advisory boards for Sanofi, Roche, and Merck; Y. Moore: was an employee of Sanofi at the time the study was conducted and has stock ownership in Sanofi;S. Brette: is an employee of Lincoln, which is a consultant to Sanofi. C. Zilocchi, F. Joulain, S. Naoshy and P. Garreau-Laporte: is an employee of Sanofi and owns stock in Sanofi; E. Dochy: is an employee of Sanofi and owns stock in Sanofi; A. Sobrero: has received honoraria for advisory boards from Amgen, Roche, Sanofi, Bayer, Merck and Celgene. All other authors have declared no conflicts of interest.