| General information |
| Database: | DB00307 |
| Objective: | Mean survival in cancer trials can be estimated with statistical techniques to extrapolate study survival curves. This methodology was applied to data from the VELOUR trial, where use of the novel biologic aflibercept in combination with fluorouracil, leucovorin, irinotecan (FOLFIRI), had significantly increased median overall survival (OS) by 1.44 months, vs placebo plus FOLFIRI in patients with metastatic colorectal cancer (mCRC) resistant to, or that had progressed following, an oxaliplatincontaining regimen. |
| Authors: | Joulain F, et al |
| Title: | Mean overall survival gain with aflibercept plus FOLFIRI vs placebo plus FOLFIRI in patients with previously treated metastatic colorectal cancer. |
| Journal: | Br J Cancer. |
| Year: | 2013 |
| PMID: | 24045663 |
| Trial Design |
| Clinical Trial Id: | NCT00561470 |
| Agent: | aflibercept
|
| Target: | VEGFA, vascular endothelial growth factor B, PIGF
|
| Cancer Type: | colorectal cancer |
| Cancer Subtype: | advanced colorectal cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | aflibercept+ FOLFIRI |
| Study Type: | a prospective multinational, doubleblind, placebocontrolled study |
| Key Patients Feature: | Eligible patients were at least 18 years old; with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2. Eligible patients had histologically or cytologically proven colorectal adenocarcinoma with metastatic disease not amenable to potentially curative treatment; measurable disease was not a requirement for participation. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | FOLFIRI+placebo |
| Treatment Info: | Parametric survival analyses were used to identify distributions with the best fit to the empirical VELOUR data. Mean OS for the two treatment groups (and predefined subgroups) was calculated from the fitted curves over a 15year survival period. |
| Primary End Point: | overall survival. |
| Secondary End Point: | NA |
| Patients Number: | 1226 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | Overall, the loglogistic distribution was the bestfitting for both treatment arms and, with it, the estimated difference in mean OS over 15 years between aflibercept+FOLFIRI and placebo+FOLFIRI was 4.7 months. In addition, the survival advantage with aflibercept was at least 3 months for the ITT population, whichever distribution was used to extrapolate survival. |
| Adverse Event(agent arm): | NA |
| Conclusions: | Extrapolation of survival curves suggests the mean OS difference for aflibercept in the VELOUR trial is at least 3 months in the ITT population and selected subgroups. |