Medline ® Abstract for Reference 128
Randomised, placebo-controlled, double-blind, parallel-group phase III study evaluating aflibercept in patients receiving first-line treatment with gemcitabine for metastatic pancreatic cancer.
Rougier P, Riess H, Manges R, Karasek P, Humblet Y, Barone C, Santoro A, Assadourian S, Hatteville L, Philip PA
Eur J Cancer. 2013;49(12):2633. Epub 2013 Apr 30.
BACKGROUND: This phase III study investigated the addition of aflibercept to gemcitabine, in patients with advanced pancreatic cancer.
PATIENTS AND METHODS: Patients with metastatic pancreatic cancer 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. The primary objective was to demonstrate an improvement in overall survival (OS) between the treatment arms.
RESULTS: The study was stopped for futility following a planned interim analysis of OS in 427 randomised patients. With a median follow-up of 7.9 months, based on the 546 patients at study termination, median OS was 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) 0.921-1.473, p=0.2034). Median progression-free survival was 3.7 months in both arms. Treatment discontinuations due to adverse events were more frequent in the aflibercept than in the placebo-containing arm (23% versus 12%).
CONCLUSION: Adding aflibercept to gemcitabine did not improve OS in patients with metastatic pancreatic cancer.
Department of Hepato-Gastroenterology and Digestive Oncology, Hôpital Européen Georges Pompidou, Paris, France. firstname.lastname@example.org