Please use this identifier to cite or link to this item: https://hdl.handle.net/2440/82415
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dc.contributor.authorSiu, L.-
dc.contributor.authorShapiro, J.-
dc.contributor.authorJonker, D.-
dc.contributor.authorKarapetis, C.-
dc.contributor.authorZalcberg, J.-
dc.contributor.authorSimes, J.-
dc.contributor.authorCouture, F.-
dc.contributor.authorMoore, M.-
dc.contributor.authorPrice, T.-
dc.contributor.authorSiddiqui, J.-
dc.contributor.authorNott, L.-
dc.contributor.authorCharpentier, D.-
dc.contributor.authorLiauw, W.-
dc.contributor.authorSawyer, M.-
dc.contributor.authorJefford, M.-
dc.contributor.authorMagoski, N.-
dc.contributor.authorHaydon, A.-
dc.contributor.authorWalters, I.-
dc.contributor.authorRingash, J.-
dc.contributor.authorTu, D.-
dc.contributor.authoret al.-
dc.date.issued2013-
dc.identifier.citationJournal of Clinical Oncology, 2013; 31(19):2477-2484-
dc.identifier.issn0732-183X-
dc.identifier.issn1527-7755-
dc.identifier.urihttp://hdl.handle.net/2440/82415-
dc.description.abstractPURPOSE The antiepidermal growth factor receptor monoclonal antibody cetuximab has improved survival in patients with metastatic, chemotherapy-refractory, wild-type K-RAS colorectal cancer. The addition of brivanib, a tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor and fibroblast growth factor receptor, to cetuximab has shown encouraging early clinical activity. PATIENTS AND METHODS Patients with metastatic colorectal cancer previously treated with combination chemotherapy were randomly assigned 1:1 to receive cetuximab 400 mg/m2 intravenous loading dose followed by weekly maintenance of 250 mg/m2 plus either brivanib 800 mg orally daily (arm A) or placebo (arm B). The primary end point was overall survival (OS). RESULTS A total of 750 patients were randomly assigned (376 in arm A and 374 in arm B). Median OS in the intent-to-treat population was 8.8 months in arm A and 8.1 months in arm B (hazard ratio [HR], 0.88; 95% CI, 0.74 to 1.03; P = .12). Median progression-free survival (PFS) was 5.0 months in arm A and 3.4 months in arm B (HR, 0.72; 95% CI, 0.62 to 0.84; P < .001). Partial responses observed (13.6% v 7.2%; P = .004) were higher in arm A. Incidence of any grade ≥ 3 adverse events was 78% in arm A and 53% in arm B. Fewer patients received ≥ 90% dose-intensity of both cetuximab (57% v 83%) and brivanib/placebo (48% v 87%) in arm A versus arm B, respectively. CONCLUSION Despite positive effects on PFS and objective response, cetuximab plus brivanib increased toxicity and did not significantly improve OS in patients with metastatic, chemotherapy-refractory, wild-type K-RAS colorectal cancer.-
dc.description.statementofresponsibilityLillian L. Siu, Jeremy D. Shapiro, Derek J. Jonker, Chris S. Karapetis, John R. Zalcberg, John Simes, Felix Couture, Malcolm J. Moore, Timothy J. Price, Jehan Siddiqui, Louise M. Nott, Danielle Charpentier, Winston Liauw, Michael B. Sawyer, Michael Jefford, Nadine M. Magoski, Andrew Haydon, Ian Walters, Jolie Ringash, Dongsheng Tu and Chris J. O'Callaghan-
dc.language.isoen-
dc.publisherAmer Soc Clinical Oncology-
dc.rights© 2013 by American Society of Clinical Oncology-
dc.source.urihttp://dx.doi.org/10.1200/jco.2012.46.0543-
dc.subjectHumans-
dc.subjectCarcinoma-
dc.subjectColorectal Neoplasms-
dc.subjectTriazines-
dc.subjectAlanine-
dc.subjectAntineoplastic Combined Chemotherapy Protocols-
dc.subjectProtein Kinase Inhibitors-
dc.subjectDisease-Free Survival-
dc.subjectTreatment Failure-
dc.subjectDrug Administration Schedule-
dc.subjectOdds Ratio-
dc.subjectDrug Resistance, Neoplasm-
dc.subjectGenes, ras-
dc.subjectAdult-
dc.subjectAged-
dc.subjectMiddle Aged-
dc.subjectFemale-
dc.subjectMale-
dc.subjectProtein-Tyrosine Kinases-
dc.subjectKaplan-Meier Estimate-
dc.subjectAntibodies, Monoclonal, Humanized-
dc.subjectCetuximab-
dc.titlePhase III randomized, placebo-controlled study of cetuximab plus brivanib alaninate versus cetuximab plus placebo in patients with metastatic, chemotherapy-refractory, wild-type K-RAS colorectal carcinoma: The NCIC clinical trials group and AGITG co.-
dc.typeJournal article-
dc.identifier.doi10.1200/JCO.2012.46.0543-
pubs.publication-statusPublished-
dc.identifier.orcidPrice, T. [0000-0002-3922-2693]-
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