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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. Garcia 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. |
