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The DOI matches its Crossref record; 8 of the 8 references it cites were found in a registry or an index.

EPIC: Phase III Trial of Cetuximab Plus Irinotecan After Fluoropyrimidine and Oxaliplatin Failure in Patients With Metastatic Colorectal Cancer

Open access
Sobrero, Alberto F., Maurel, Joan, Fehrenbacher, Louis, Scheithauer, Werner, Abubakr, Yousif A., Lutz, Manfred P., Vega-Villegas, M. Eugenia, Eng, Cathy, Steinhauer, Ernst U., Prausova, Jana, Lenz, Heinz-Josef, Borg, Christophe, Middleton, Gary, Kröning, Hendrik, Luppi, Gabriele, Kisker, Oliver, Zubel, Angela, Langer, Christiane, Kopit, Justin, Burris, Howard A.·2008·Journal of Clinical Oncology

Abstract

Purpose: To determine whether adding cetuximab to irinotecan prolongs survival in patients with metastatic colorectal cancer (mCRC) previously treated with fluoropyrimidine and oxaliplatin. Patients and Methods: This multicenter, open-label, phase III study randomly assigned 1,298 patients with epidermal growth factor receptor–expressing mCRC who had experienced first-line fluoropyrimidine and oxaliplatin treatment failure to cetuximab (400 mg/m 2 day 1 followed by 250 mg/m 2 weekly) plus irinotecan (350 mg/m 2 every 3 weeks) or irinotecan alone. Primary end point was overall survival (OS); secondary end points included progression-free survival (PFS), response rate (RR), and quality of life (QOL). Results: Median OS was comparable between treatments: 10.7 months (95% CI, 9.6 to 11.3) with cetuximab/irinotecan and 10.0 months (95% CI, 9.1 to 11.3) with irinotecan alone (hazard ratio [HR], 0.975; 95% CI, 0.854 to 1.114; P = .71). This lack of difference may have been due to post-trial therapy: 46.9% of patients assigned to irinotecan eventually received cetuximab (87.2% of those who did, received it with irinotecan). Cetuximab added to irinotecan significantly improved PFS (median, 4.0 v 2.6 months; HR, 0.692; 95% CI, 0.617 to 0.776; P ≤ .0001) and RR (16.4% v 4.2%; P < .0001), and resulted in significantly better scores in the QOL analysis of global health status (P = .047). Cetuximab did not exacerbate toxicity, except for acneform rash, diarrhea, hypomagnesemia, and associated electrolyte imbalances. Neutropenia was the most common severe toxicity across treatment arms. Conclusion: Cetuximab and irinotecan improved PFS and RR, and resulted in better QOL versus irinotecan alone. OS was similar between study groups, possibly influenced by the large number of patients in the irinotecan arm who received cetuximab and irinotecan poststudy.

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Metadata

Authors
Sobrero, A. F., Maurel, J., Fehrenbacher, L., Scheithauer, W., Abubakr, Y. A., Lutz, M. P., Vega-Villegas, M. E., Eng, C., Steinhauer, E. U., Prausova, J., Lenz, H.-J., Borg, C., Middleton, G., Kröning, H., Luppi, G., Kisker, O., Zubel, A., Langer, C., Kopit, J., & Burris, H. A.
Venue
Journal of Clinical Oncology
Published
2008-05-10
Volume
26
Issue
14
Pages
2311-2319
ISSN
  • 0732-183X (ISSN-L)
  • 1527-7755
OpenAlex
W2156700619
Cited by
946
References
8
FWCI
41.89
Type
journal article
Language
en
Open access
bronze

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CoChat. (2026). Citation check: EPIC: Phase III Trial of Cetuximab Plus Irinotecan After Fluoropyrimidine and Oxaliplatin Failure in Patients With Metastatic Colorectal Cancer. https://app.cochat.ai/papers/10.1200/jco.2007.13.1193
The paper
Sobrero, A. F., Maurel, J., Fehrenbacher, L., Scheithauer, W., Abubakr, Y. A., Lutz, M. P., Vega-Villegas, M. E., Eng, C., Steinhauer, E. U., Prausova, J., Lenz, H.-J., Borg, C., Middleton, G., Kröning, H., Luppi, G., Kisker, O., Zubel, A., Langer, C., Kopit, J., & Burris, H. A. (2008). EPIC: Phase III Trial of Cetuximab Plus Irinotecan After Fluoropyrimidine and Oxaliplatin Failure in Patients With Metastatic Colorectal Cancer. Journal of Clinical Oncology. https://doi.org/10.1200/jco.2007.13.1193

Data sources

Bibliographic data: Semantic Scholar, OpenAlex, Crossref.

Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.