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https://hdl.handle.net/2440/52398
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dc.contributor.author | Karapetis, C. | - |
dc.contributor.author | Khambata-Ford, S. | - |
dc.contributor.author | Jonker, D. | - |
dc.contributor.author | O'Callaghan, C. | - |
dc.contributor.author | Tu, D. | - |
dc.contributor.author | Tebbutt, N. | - |
dc.contributor.author | Simes, R. | - |
dc.contributor.author | Chalchal, H. | - |
dc.contributor.author | Shapiro, J. | - |
dc.contributor.author | Robitaille, S. | - |
dc.contributor.author | Price, T. | - |
dc.contributor.author | Shepherd, L. | - |
dc.contributor.author | Au, H. | - |
dc.contributor.author | Langer, C. | - |
dc.contributor.author | Moore, M. | - |
dc.contributor.author | Zalcberg, J. | - |
dc.date.issued | 2008 | - |
dc.identifier.citation | New England Journal of Medicine, 2008; 359(17):1757-1765 | - |
dc.identifier.issn | 0028-4793 | - |
dc.identifier.issn | 1533-4406 | - |
dc.identifier.uri | http://hdl.handle.net/2440/52398 | - |
dc.description.abstract | Background: Treatment with cetuximab, a monoclonal antibody directed against the epidermal growth factor receptor, improves overall and progression-free survival and preserves the quality of life in patients with colorectal cancer that has not responded to chemotherapy. The mutation status of the K-ras gene in the tumor may affect the response to cetuximab and have treatment-independent prognostic value. Methods: We analyzed tumor samples, obtained from 394 of 572 patients (68.9%) with colorectal cancer who were randomly assigned to receive cetuximab plus best supportive care or best supportive care alone, to look for activating mutations in exon 2 of the K-ras gene. We assessed whether the mutation status of the K-ras gene was associated with survival in the cetuximab and supportive-care groups. Results: Of the tumors evaluated for K-ras mutations, 42.3% had at least one mutation in exon 2 of the gene. The effectiveness of cetuximab was significantly associated with K-ras mutation status (P=0.01 and P<0.001 for the interaction of K-ras mutation status with overall survival and progression-free survival, respectively). In patients with wild-type K-ras tumors, treatment with cetuximab as compared with supportive care alone significantly improved overall survival (median, 9.5 vs. 4.8 months; hazard ratio for death, 0.55; 95% confidence interval [CI], 0.41 to 0.74; P<0.001) and progression-free survival (median, 3.7 months vs. 1.9 months; hazard ratio for progression or death, 0.40; 95% CI, 0.30 to 0.54; P<0.001). Among patients with mutated K-ras tumors, there was no significant difference between those who were treated with cetuximab and those who received supportive care alone with respect to overall survival (hazard ratio, 0.98; P=0.89) or progression-free survival (hazard ratio, 0.99; P=0.96). In the group of patients receiving best supportive care alone, the mutation status of the K-ras gene was not significantly associated with overall survival (hazard ratio for death, 1.01; P=0.97). Conclusions: Patients with a colorectal tumor bearing mutated K-ras did not benefit from cetuximab, whereas patients with a tumor bearing wild-type K-ras did benefit from cetuximab. The mutation status of the K-ras gene had no influence on survival among patients treated with best supportive care alone. | - |
dc.description.statementofresponsibility | Christos S. Karapetis, Shirin Khambata-Ford, Derek J. Jonker, Chris J. O'Callaghan, Dongsheng Tu, Niall C. Tebbutt, R. John Simes, Haji Chalchal, Jeremy D. Shapiro, Sonia Robitaille, Timothy J. Price, Lois Shepherd, Heather-Jane Au, Christiane Langer, Malcolm J. Moore and John R. Zalcberg | - |
dc.language.iso | en | - |
dc.publisher | Massachusetts Medical Soc | - |
dc.source.uri | http://dx.doi.org/10.1056/nejmoa0804385 | - |
dc.subject | Humans | - |
dc.subject | Colorectal Neoplasms | - |
dc.subject | Disease Progression | - |
dc.subject | Antineoplastic Agents | - |
dc.subject | Antibodies, Monoclonal | - |
dc.subject | Palliative Care | - |
dc.subject | DNA Mutational Analysis | - |
dc.subject | Mutation | - |
dc.subject | Genes, ras | - |
dc.subject | Quality of Life | - |
dc.subject | Adult | - |
dc.subject | Aged | - |
dc.subject | Aged, 80 and over | - |
dc.subject | Middle Aged | - |
dc.subject | Female | - |
dc.subject | Male | - |
dc.subject | Kaplan-Meier Estimate | - |
dc.subject | Antibodies, Monoclonal, Humanized | - |
dc.subject | ErbB Receptors | - |
dc.subject | Cetuximab | - |
dc.title | K-ras mutations and benefit from cetuximab in advanced colorectal cancer | - |
dc.type | Journal article | - |
dc.identifier.doi | 10.1056/NEJMoa0804385 | - |
pubs.publication-status | Published | - |
dc.identifier.orcid | Price, T. [0000-0002-3922-2693] | - |
Appears in Collections: | Aurora harvest 5 Medicine publications |
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