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Journal of Clinical Oncology, Vol 24, No 30 (October 20), 2006: pp. 4914-4921
© 2006 American Society of Clinical Oncology.
DOI: 10.1200/JCO.2006.06.7595
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Multicenter Phase II and Translational Study of Cetuximab in Metastatic Colorectal Carcinoma Refractory to Irinotecan, Oxaliplatin, and Fluoropyrimidines

Heinz-Josef Lenz, Eric Van Cutsem, Shirin Khambata-Ford, Robert J. Mayer, Philip Gold, Philip Stella, Barry Mirtsching, Allen L. Cohn, Andrew W. Pippas, Nozar Azarnia, Zenta Tsuchihashi, David J. Mauro, Eric K. Rowinsky

From the Norris Comprehensive Cancer Center, University of Southern California, Los Angeles, CA; University Hospital Gasthuisberg, Leuven, Belgium; Bristol-Myers Squibb Pharmaceutical Research Institute, Princeton, NJ; Dana-Farber/Partners CancerCare, Boston, MA; Swedish Cancer Institute, Seattle, WA; St Joseph Mercy Hospital, Ann Arbor, MI; Center for Oncology Research and Treatment, Dallas, TX; Rocky Mountain Cancer Center, Denver, CO; Lakeland Regional Cancer Center, Lakeland, FL; and ImClone Systems Incorporated, New York, NY

Address reprint requests to Eric K. Rowinsky, MD, ImClone Systems, 33 ImClone Dr, Branchburg, NJ 08876; e-mail: eric.rowinsky{at}imclone.com

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/m2 followed by 250 mg/m2 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.

Supported by ImClone Systems, New York, NY, and Merck, Darmstadt, Germany.

The investigators and centers participating in this multicenter, multinational study are listed in online only Appendix 1.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.


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