The DOI matches its Crossref record; 8 of the 8 references it cites were found in a registry or an index.
Multicenter Phase II and Translational Study of Cetuximab in Metastatic Colorectal Carcinoma Refractory to Irinotecan, Oxaliplatin, and Fluoropyrimidines
Open accessAbstract
Purpose: This multicenter study evaluated the antitumor activity of cetuximab, an immunoglobulin G1 antibody directed at the epidermal growth factor receptor (EGFR), in metastatic colorectal carcinoma (CRC) refractory to irinotecan, oxaliplatin, and a fluoropyrimidine. It also evaluated the safety, pharmacokinetics, immunokinetics, and biologic determinants of activity. Patients and Methods: Patients with metastatic CRC, whose tumors demonstrated EGFR immunostaining and were refractory to irinotecan, oxaliplatin, and fluoropyrimidines, were treated with cetuximab at a loading dose of 400 mg/m 2 followed by 250 mg/m 2 weekly. An independent review committee (IRC) reviewed responses. Blood was collected for cetuximab pharmacokinetics and to detect antibodies to cetuximab. EGFR gene sequencing of the tyrosine kinase domain and gene copy number assessments were performed. Results: The response rates in 346 patients, as determined by the investigators and IRC, were 12.4% (95% CI, 9.1 to 16.4) and 11.6% (95% CI, 8.4 to 16.4). The median progression-free survival (PFS) and survival times were 1.4 months (95% CI, 1.4 to 2.1) and 6.6 months (95% CI, 5.6 to 7.6), respectively. An acneiform rash occurred in 82.9% of patients; grade 3 rash was observed in 4.9%. Response and survival related strongly to the severity of the rash. In contrast, clinical benefit did not relate to EGFR immunostaining. EGFR tyrosine kinase domain mutations were not identified, and EGFR gene copy number did not relate to response or PFS, but to survival (P = .03). Conclusion: Cetuximab is active and well tolerated in metastatic CRC refractory to irinotecan, oxaliplatin, and fluoropyrimidines. The severity of rash was related to efficacy. Neither EGFR kinase domain mutations nor EGFR gene amplification appear to be essential for response to cetuximab in this setting.
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Cites
New Guidelines to Evaluate the Response to Treatment in Solid Tumors
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EGFR Mutations in Lung Cancer: Correlation with Clinical Response to Gefitinib Therapy
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Epidermal growth factor receptor inhibition strategies in oncology
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Molecular determinants of cetuximab efficacy.
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Self-citation(2006) · New England Journal of Medicine · doi:10.1056/nejmc052564 · Cited by 189
Cited by
Cetuximab and Chemotherapy as Initial Treatment for Metastatic Colorectal Cancer
Van Cutsem, E., Köhne, C.-H., Hitre, E., Zaluski, J., Chang Chien, C.-R., Makhson, A., D'Haens, G., Pintér, T., Lim, R., Bodoky, G., et al. (2009) · New England Journal of Medicine · doi:10.1056/nejmoa0805019 · Cited by 3,877
K-ras Mutations and Benefit from Cetuximab in Advanced Colorectal Cancer
Karapetis, C. S., Khambata-Ford, S., Jonker, D. J., O'Callaghan, C. J., Tu, D., Tebbutt, N. C., Simes, R. J., Chalchal, H., Shapiro, J. D., Robitaille, S., et al. (2008) · New England Journal of Medicine · doi:10.1056/nejmoa0804385 · Cited by 3,622
Self-citationVan Cutsem, E., Peeters, M., Siena, S., Humblet, Y., Hendlisz, A., Neyns, B., Canon, J.-L., Van Laethem, J.-L., Maurel, J., Richardson, G., et al. (2007) · Journal of Clinical Oncology · doi:10.1200/jco.2006.08.1620 · Cited by 1,979
Khambata-Ford, S., Garrett, C. R., Meropol, N. J., Basik, M., Harbison, C. T., Wu, S., Wong, T. W., Huang, X., Takimoto, C. H., Godwin, A. K., et al. (2007) · Journal of Clinical Oncology · doi:10.1200/jco.2006.10.5437 · Cited by 1,125
Self-citationBertotti, A., Migliardi, G., Galimi, F., Sassi, F., Torti, D., Isella, C., Corà, D., Di Nicolantonio, F., Buscarino, M., Petti, C., et al. (2011) · Cancer Discovery · doi:10.1158/2159-8290.cd-11-0109 · Cited by 939
Metadata
- Authors
- Lenz, H.-J., Van Cutsem, E., Khambata-Ford, S., Mayer, R. J., Gold, P., Stella, P., Mirtsching, B., Cohn, A. L., Pippas, A. W., Azarnia, N., Tsuchihashi, Z., Mauro, D. J., & Rowinsky, E. K.
- Venue
- Journal of Clinical Oncology
- Published
- 2006-10-20
- Volume
- 24
- Issue
- 30
- Pages
- 4914-4921
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2146100972
- Cited by
- 528
- References
- 8
- FWCI
- 33.33
- Type
- journal article
- Language
- en
- Open access
- bronze
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- Lenz, H.-J., Van Cutsem, E., Khambata-Ford, S., Mayer, R. J., Gold, P., Stella, P., Mirtsching, B., Cohn, A. L., Pippas, A. W., Azarnia, N., Tsuchihashi, Z., Mauro, D. J., & Rowinsky, E. K. (2006). Multicenter Phase II and Translational Study of Cetuximab in Metastatic Colorectal Carcinoma Refractory to Irinotecan, Oxaliplatin, and Fluoropyrimidines. Journal of Clinical Oncology. https://doi.org/10.1200/jco.2006.06.7595
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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
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