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Type: Journal article
Title: Final results from a randomized phase 3 study of FOLFIRI ± panitumumab for second-line treatment of metastatic colorectal cancer
Other Titles: Final results from a randomized phase 3 study of FOLFIRI +/- panitumumab for second-line treatment of metastatic colorectal cancer
Author: Peeters, M.
Price, T.
Cervantes, A.
Sobrero, A.
Ducreux, M.
Hotko, Y.
Andre, T.
Chan, E.
Lordick, F.
Punt, C.
Strickland, A.
Wilson, G.
Ciuleanu, T.
Roman, L.
Van Cutsem, E.
Tian, Y.
Sidhu, R.
Citation: Annals of Oncology, 2014; 25(1):107-116
Publisher: Oxford University Press (OUP)
Issue Date: 2014
ISSN: 1569-8041
Statement of
M. Peeters, T. J. Price, A. Cervantes, A. F. Sobrero, M. Ducreux, Y. Hotko, T. André, E. Chan, F. Lordick, C. J. A. Punt, A. H. Strickland, G. Wilson, T. E. Ciuleanu, L. Roman, E. Van Cutsem, Y. Tian and R. Sidhu
Abstract: Background: The study 20050181 demonstrated significant improvements in progression-free survival (PFS), objective response, and a nonsignificant trend toward increased overall survival (OS) with panitumumab–FOLFIRI versus FOLFIRI alone for second-line wild-type (WT) KRAS metastatic colorectal cancer (mCRC). Updated long-term data from a prespecified descriptive analysis are reported. Patients and methods: Patients receiving one prior mCRC treatment were randomly assigned (1:1) to panitumumab (6.0 mg/kg)–FOLFIRI versus FOLFIRI every 2 weeks. Co-primary end points (PFS and OS) were prospectively analyzed by tumor KRAS status. Results: One thousand one hundred and eighty-six patients were randomly assigned. In patients with WT KRAS tumors, panitumumab–FOLFIRI significantly improved PFS versus FOLFIRI [median 6.7 versus 4.9 months; hazard ratio (HR) 0.82 [95% confidence interval (CI) 0.69, 0.97]; P = 0.023]. A trend toward longer OS was observed (median 14.5 versus 12.5 months; HR 0.92 [95% CI 0.78, 1.10]; P = 0.37). Response rates improved from 10% to 36% (P < 0.0001). From post hoc analyses in patients receiving prior oxaliplatin–bevacizumab, panitumumab–FOLFIRI improved PFS (median 6.4 versus 3.7 months; HR 0.58 [95% CI 0.37, 0.90]; P = 0.014). PFS and OS appeared longer for worst-grade skin toxicity of 2–4, versus 0–1 or FOLFIRI. Safety results were as previously reported and consistent with the known toxicities with anti-epidermal growth factor receptor therapy. Conclusions: These data confirm the primary efficacy and safety findings of this trial and support panitumumab–FOLFIRI as a second-line treatment of WT KRAS mCRC.
Keywords: antibody; chemotherapy; FOLFIRI; metastatic colorectal cancer; panitumumab
Rights: © The Author 2013. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email:
DOI: 10.1093/annonc/mdt523
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