Randomised, placebo-controlled, double-blind, parallele-group phase III study evaluating aflibercept in patients receiving first-line treatment with gemcitabine for metastatic pancreatic cancer

Carlo Antonio Barone, Philippe Rougier, Hanno Riess, Robert Manges, Petr Karasek, Yves Humblet, Armando Santoro, Sylvie Assadourian, Laurence Hatteville, Philip A. Philip

Risultato della ricerca: Contributo in rivistaArticolo in rivistapeer review

128 Citazioni (Scopus)

Abstract

Abstract 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/m2 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.
Lingua originaleEnglish
pagine (da-a)2633-2642
Numero di pagine10
RivistaEuropean journal of cancer
Volume49
DOI
Stato di pubblicazionePubblicato - 2013

Keywords

  • Aflibercept
  • Angiogenesis

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