Cetuximab Monotherapy and Cetuximab plus Irinotecan in Irinotecan-Refractory Metastatic Colorectal Cancer
Open accessAbstract
BACKGROUND: The epidermal growth factor receptor (EGFR), which participates in signaling pathways that are deregulated in cancer cells, commonly appears on colorectal-cancer cells. Cetuximab is a monoclonal antibody that specifically blocks the EGFR. We compared the efficacy of cetuximab in combination with irinotecan with that of cetuximab alone in metastatic colorectal cancer that was refractory to treatment with irinotecan. METHODS: We randomly assigned 329 patients whose disease had progressed during or within three months after treatment with an irinotecan-based regimen to receive either cetuximab and irinotecan (at the same dose and schedule as in a prestudy regimen [218 patients]) or cetuximab monotherapy (111 patients). In cases of disease progression, the addition of irinotecan to cetuximab monotherapy was permitted. The patients were evaluated radiologically for tumor response and were also evaluated for the time to tumor progression, survival, and side effects of treatment. RESULTS: The rate of response in the combination-therapy group was significantly higher than that in the monotherapy group (22.9 percent [95 percent confidence interval, 17.5 to 29.1 percent] vs. 10.8 percent [95 percent confidence interval, 5.7 to 18.1 percent], P=0.007). The median time to progression was significantly greater in the combination-therapy group (4.1 vs. 1.5 months, P<0.001 by the log-rank test). The median survival time was 8.6 months in the combination-therapy group and 6.9 months in the monotherapy group (P=0.48). Toxic effects were more frequent in the combination-therapy group, but their severity and incidence were similar to those that would be expected with irinotecan alone. CONCLUSIONS: Cetuximab has clinically significant activity when given alone or in combination with irinotecan in patients with irinotecan-refractory colorectal cancer.
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The EGFR pathway is particularly relevant in the pathogenesis of pancreatic and colorectal cancers.
“Given the particular relevance of the EGFR pathway in the pathogenesis of pancreatic and colorectal cancers [16, 17]”
From Anti-tumor efficacy of a potent and selective non-covalent KRASG12D inhibitor (2022) · cites this paper as [16]
The paper’s discussion of EGFR states that it is relevant to colorectal cancer and describes cancer-related processes regulated by its signaling pathway (results section; page unavailable). The copy does not make the same claim about pancreatic cancer; pancreatic cancer appears only in a cited reference title. (LLM, conf=0.88)
Experimental — accuracy not yet measuredThe first biological agents targeting EGFR and VEGF(R) further improved systemic treatment.
“The first biological agents targeting the epidermal growth factor receptor (EGFR) and VEGF (receptor) (VEGF(R)) further improved systemic treatment;21 22”
From Current and emerging concepts for systemic treatment of metastatic colorectal cancer (2025) · cites this paper as [21]
Cetuximab provides clinical benefit primarily in colorectal cancers that do not harbor KRAS mutations and in those with high expression of EGFR ligands amphiregulin and epiregulin.
“Importantly, cetuximab provides clinical benefit primarily in colorectal cancers that do not harbor KRAS mutations (Cunningham et al., 2004) and in those with high expression of EGFR ligands amphiregulin and epiregulin (Khambata-Ford et al., 2007).”
From ERBB Receptors: From Oncogene Discovery to Basic Science to Mechanism-Based Cancer Therapeutics (2014) · cites this paper as Cunningham et al., 2004
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- Authors
- Cunningham, D., Humblet, Y., Siena, S., Khayat, D., Bleiberg, H., Santoro, A., Bets, D., Mueser, M., Harstrick, A., Verslype, C., Chau, I., & Van Cutsem, E.
- Affiliations
- Royal Marsden Hospital (GB)
- UCLouvain (BE)
- Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda (IT)
- Pitié-Salpêtrière Hospital (FR)
- Institut Jules Bordet (BE)
- IRCCS Humanitas Research Hospital (IT)
- Merck KGaA, Darmstadt (Germany) (DE)
- Universitair Ziekenhuis Leuven (BE)
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2004-07-22
- Volume
- 351
- Issue
- 4
- Pages
- 337-345
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2142564546
- Cited by
- 5,035
- References
- 37
- Citations by year
- 2026: 38 · 2025: 60 · 2024: 93 · 2023: 117 · 2022: 121 · 2021: 100 · 2020: 129 · 2019: 134 · 2018: 123 · 2017: 161 · 2016: 228 · 2015: 243 · 2014: 277 · 2013: 297 · 2012: 315
- FWCI
- 171.22
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Digital Access to Libraries (Université catholique de Louvain (UCL), l'Université de Namur (UNamur) and the Université Saint-Louis (USL-B)) (submittedVersion)
- Dépôt institutionnel de l'Université libre de Bruxelles (Université Libre de Bruxelles) (submittedVersion)
- Topics
- Health Sciences › Medicine › Oncology › Colorectal Cancer Treatments and Studies
- Health Sciences › Medicine › Oncology › Colorectal Cancer Surgical Treatments
- Health Sciences › Medicine › Oncology › HER2/EGFR in Cancer Research
- Keywords
- cetuximab, irinotecan, metastatic colorectal cancer, irinotecan-refractory disease, EGFR inhibition, monoclonal antibodies, combination chemotherapy, time to progression, survival, treatment toxicity
- MeSH terms
- Cetuximab, Irinotecan, Adenocarcinoma, Adult, Aged, Aged, 80 and over, Antibodies, Monoclonal, Antineoplastic Agents, Antineoplastic Combined Chemotherapy Protocols, Camptothecin, Exanthema, Female, Humans, Male, Middle Aged, Neoplasm Metastasis, Colorectal Neoplasms, Survival Analysis, Single-Blind Method, Disease Progression, Topoisomerase I Inhibitors, Antibodies, Monoclonal, Humanized, ErbB Receptors
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