VAN CUTSEM, Eric, Josep TABERNERO, Radek LAKOMÝ, Hans PRENEN, Jana PRAUSOVÁ, Teresa MACARULLA, Paul RUFF, Guy A. VAN HAZEL, Vladimir MOISEYENKO, David FERRY, Joe MCKENDRICK, Jonathan POLIKOFF, Alexia TELLIER, Remi CASTAN and Carmen ALLEGRA. Addition of Aflibercept to Fluorouracil, Leucovorin, and Irinotecan Improves Survival in a Phase III Randomized Trial in Patients With Metastatic Colorectal Cancer Previously Treated With an Oxaliplatin-Based Regimen. Journal of clinical oncology. United States: American Society of Clinical Oncology, 2012, vol. 30, No 28, p. 3499-3506. ISSN 0732-183X. Available from: https://dx.doi.org/10.1200/JCO.2012.42.8201.
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Basic information
Original name Addition of Aflibercept to Fluorouracil, Leucovorin, and Irinotecan Improves Survival in a Phase III Randomized Trial in Patients With Metastatic Colorectal Cancer Previously Treated With an Oxaliplatin-Based Regimen
Authors VAN CUTSEM, Eric, Josep TABERNERO, Radek LAKOMÝ, Hans PRENEN, Jana PRAUSOVÁ, Teresa MACARULLA, Paul RUFF, Guy A. VAN HAZEL, Vladimir MOISEYENKO, David FERRY, Joe MCKENDRICK, Jonathan POLIKOFF, Alexia TELLIER, Remi CASTAN and Carmen ALLEGRA.
Edition Journal of clinical oncology, United States, American Society of Clinical Oncology, 2012, 0732-183X.
Other information
Original language English
Type of outcome Article in a journal
Field of Study 30200 3.2 Clinical medicine
Country of publisher United States of America
Confidentiality degree is not subject to a state or trade secret
Impact factor Impact factor: 18.038
Organization unit Faculty of Medicine
Doi http://dx.doi.org/10.1200/JCO.2012.42.8201
UT WoS 000309517700015
Keywords in English ENDOTHELIAL GROWTH-FACTOR; ADVANCED SOLID TUMORS; VEGF-TRAP; ANGIOGENESIS; BEVACIZUMAB; CONSORTIUM; RECURRENT
Tags International impact, Reviewed
Changed by Changed by: Ing. Mgr. Věra Pospíšilíková, učo 9005. Changed: 23/4/2014 15:28.
Abstract
Purpose Treatment for metastatic colorectal cancer (mCRC) commonly involves a fluoropyrimidine-based chemotherapy regimen such as infusional fluorouracil, leucovorin, and irinotecan (FOLFIRI) or fluorouracil, leucovorin, and oxaliplatin, often combined with bevacizumab or an epidermal growth factor receptor monoclonal antibody. We studied the effect of adding the novel antiangiogenic agent aflibercept (also known as ziv-aflibercept in the United States) to FOLFIRI in patients with mCRC previously treated with oxaliplatin, including patients who received prior bevacizumab. Results Adding aflibercept to FOLFIRI significantly improved overall survival relative to placebo plus FOLFIRI (hazard ratio [HR], 0.817; 95.34% CI, 0.713 to 0.937; P = .0032) with median survival times of 13.50 versus 12.06 months, respectively. Aflibercept also significantly improved progression-free survival (PFS; HR, 0.758; 95% CI, 0.661 to 0.869; P < .0001), with median PFS times of 6.90 versus 4.67 months, respectively. The effects on overall survival and PFS exhibited a consistent trend across prespecified subgroup analyses, including bevacizumab pretreated patients. Response rate was 19.8% (95% CI, 16.4% to 23.2%) with aflibercept plus FOLFIRI compared with 11.1% (95% CI, 8.5% to 13.8%) with placebo plus FOLFIRI (P = .0001). Adverse effects reported with aflibercept combined with FOLFIRI included the characteristic anti-vascular endothelial growth factor effects and also reflected an increased incidence of some chemotherapy-related toxicities. Conclusion Aflibercept in combination with FOLFIRI conferred a statistically significant survival benefit over FOLFIRI combined with placebo in patients with mCRC previously treated with oxaliplatin. J Clin Oncol 30:3499-3506. (C) 2012 by American Society of Clinical Oncology
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