| General information |
| Database: | DB00923 |
| Objective: | Thisphase III study investigated the addition of aflibercept to gemcitabine, in patients with advanced pancreatic cancer. |
| Authors: | Rougier P, et al |
| Title: | Randomised, placebocontrolled, doubleblind, parallelgroupphase III study evaluating aflibercept in patients receiving firstline treatment with gemcitabine for metastatic pancreatic cancer. |
| Journal: | Eur J Cancer. |
| Year: | 2013 |
| PMID: | 23642329 |
| Trial Design |
| Clinical Trial Id: | NCT00574275 |
| Agent: | aflibercept
|
| Target: | Vascular endothelial growth factor receptor 2
|
| Cancer Type: | pancreatic cancer |
| Cancer Subtype: | advanced pancreatic cancer. |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | Randomised, placebocontrolled, doubleblind, parallelgroupphase III study |
| Key Patients Feature: | Patients with metastatic pancreatic cancer |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | aflibercept versus placebo |
| Treatment Info: | pts were randomly assigned to receive either intravenous (i.v.) aflibercept, 4 mg/kg every 2 weeks, or matching placebo combined with gemcitabine, 1000 mg/m(2) i.v. weekly for 7 weeks out of 8, then weekly for 3 weeks out of 4 until progressive disease, unacceptable toxicity or withdrawal of consent. |
| Primary End Point: | an improvement in overall survival (OS) between the treatment arms. |
| Secondary End Point: | NA |
| Patients Number: | 427 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 3.7 months in both arms. |
| Median OS A vs. C: | 7.8 months in the gemcitabine plus placebo arm (n=275) versus 6.5 months in the gemcitabine plus aflibercept arm (n=271), which was not significant (hazard ratio 1.165, 95% confidence interval (CI) 0.9211.473, p=0.2034). |
| Adverse Event(agent arm): | The greater incidence of grade 3/4 AEs in the aflibercept than the placebo arm was mainly due to hypertension events (13% versus 3%). |
| Conclusions: | Adding aflibercept to gemcitabine did not improve OS in patients with metastatic pancreatic cancer. |