Journal article
A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial of Pegfilgrastim in Patients Receiving First-Line FOLFOX/Bevacizumab or FOLFIRI/Bevacizumab for Locally Advanced or Metastatic Colorectal Cancer: Final Results of the Pegfilgrastim and Anti-VEGF Evaluation Study (PAVES)
T Pinter, Z Klippel, A Cesas, A Croitoru, J Decaestecker, P Gibbs, Y Hotko, J Jassem, G Kurteva, J Novotny, S O'Reilly, T Salek, M Reiner, PK Morrow, MR Choi, S Whittaker, C Blanke
Clinical Colorectal Cancer | CIG MEDIA GROUP, LP | Published : 2017
Abstract
In a phase III, double-blind trial, 845 patients with advanced colorectal cancer receiving bevacizumab plus first-line chemotherapy (FOLFOX [leucovorin), 5-fluorouracil, oxaliplatin] or FOLFIRI [leucovorin, 5-fluorouracil, irinotecan]) were randomized to pegfilgrastim versus placebo. Pegfilgrastim significantly reduced grade 3/4 febrile neutropenia, with no differences in tumor response rates, survival outcomes, or nonhematologic toxicities observed between the 2 arms. Background Pegfilgrastim's role in reducing the risk of febrile neutropenia (FN) in patients with colorectal cancer (CRC) receiving chemotherapy plus bevacizumab was not previously evaluated in a prospective study. The present..
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Funding Acknowledgements
This work was supported by Amgen Inc. Kathryn Boorer of Amgen Inc and Martha Mutomba (on behalf of Amgen Inc) provided writing assistance. The authors thank Esteban Abella, a former employee of Amgen Inc, and May Mo of Amgen Inc for their involvement in the study design and analysis and interpretation of data. The authors also thank Florian Vogl of Amgen Inc for useful discussions.