K-ras Mutations and Benefit from Cetuximab in Advanced Colorectal Cancer
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. (ClinicalTrials.gov number, NCT00079066.)
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Exclusion of patients with KRAS exon 2-mutant tumors has increased the percentage of responders to anti-EGFR monoclonal antibodies to 13-17%.
“Although exclusion of patients with KRAS (exon 2)-mutant tumors has arithmetically increased the percentage of responders up to 13–17 %”
From Primary and acquired resistance to EGFR-targeted therapies in colorectal cancer: impact on future treatment strategies (2014) · cites this paper as [26]
KRAS exon 2 mutations (codons 12 and 13) are found in approximately 40-45% of colorectal cancers.
“KRAS mutations in exon 2 (codons 12 and 13), which are found in approximately 40–45 % of CRCs [20, 26]”
From Primary and acquired resistance to EGFR-targeted therapies in colorectal cancer: impact on future treatment strategies (2014) · cites this paper as [26]
Most KRAS wild-type colorectal tumors still do not respond to anti-EGFR monoclonal antibodies.
“most KRAS wild-type tumors still do not respond to anti-EGFR moAbs [26, 32].”
From Primary and acquired resistance to EGFR-targeted therapies in colorectal cancer: impact on future treatment strategies (2014) · cites this paper as [26]
Cetuximab did not demonstrate superiority over best supportive care in 394 metastatic colorectal cancer patients with KRAS-activating mutations who had undergone multiple treatment lines.
“A comparison of cetuximab and the best supportive care in 394 mCRC patients who had undergone multiple treatment lines did not demonstrate cetuximab’s superiority in those with KRAS-activating mutations [12].”
From RAS Mutations in Advanced Colorectal Cancer: Mechanisms, Clinical Implications, and Novel Therapeutic Approaches (2025) · cites this paper as [12]
Gene mutations downstream of the EGFR signalling pathway, including RAS/RAF/MEK and PI3K/AKT/mTOR, significantly contribute to drug resistance to anti-EGFR monoclonal antibodies.
“Gene mutations downstream of the EGFR signalling pathway, including RAS/RAF/MEK and PI3K/AKT/mTOR, significantly contribute to drug resistance [9–11].”
From Resistance to anti-EGFR therapies in metastatic colorectal cancer: underlying mechanisms and reversal strategies (2021) · cites this paper as [9]
KRAS mutation is the most common RAS mutation, occurring in 40% of metastatic colorectal cancer.
“Mutations in RAS usually occur in KRAS, NRAS and HRAS, and the KRAS mutation is the most common of these genomic alterations, occurring in 40% of mCRC [9, 80].”
From Resistance to anti-EGFR therapies in metastatic colorectal cancer: underlying mechanisms and reversal strategies (2021) · cites this paper as [9]
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“Furthermore, it has been demonstrated in several clinical trials that patients with mCRC and a KRAS mutation do not respond to cetuximab therapy (Lievre et al., 2006; Benvenuti et al., 2007; Di Fiore et al., 2007; Khambata-Ford et al., 2007; Cappuzzo et al., 2008; De Roock et al., 2008; Karapetis et al., 2008).”
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- Authors
- 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., Price, T. J., Shepherd, L., Au, H.-J., Langer, C., Moore, M. J., & Zalcberg, J. R.
- Affiliations
- Flinders University (AU)
- University of Ottawa (CA)
- Canadian Cancer Trials Group (CA)
- Austin Health (AU)
- The University of Sydney (AU)
- The Alfred Hospital (AU)
- Queen Elizabeth Hospital (AU)
- Cross Cancer Institute (CA)
- Bristol-Myers Squibb (United States) (US)
- Princess Margaret Cancer Centre (CA)
- The University of Melbourne (AU)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2008-10-23
- Volume
- 359
- Issue
- 17
- Pages
- 1757-1765
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2155311724
- Cited by
- 3,622
- References
- 33
- Citations by year
- 2026: 69 · 2025: 69 · 2024: 90 · 2023: 92 · 2022: 112 · 2021: 159 · 2020: 168 · 2019: 171 · 2018: 166 · 2017: 208 · 2016: 223 · 2015: 256 · 2014: 321 · 2013: 312 · 2012: 324
- FWCI
- 154.78
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Adelaide Research & Scholarship (AR&S) (University of Adelaide) (submittedVersion)
- Topics
- Health Sciences › Medicine › Oncology › Colorectal Cancer Treatments and Studies
- Health Sciences › Medicine › Oncology › Colorectal Cancer Surgical Treatments
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
- Keywords
- cetuximab, advanced colorectal cancer, epidermal growth factor receptor, predictive biomarkers, best supportive care, overall survival, progression-free survival, treatment response
- MeSH terms
- Cetuximab, Adult, Aged, Aged, 80 and over, Antibodies, Monoclonal, Antineoplastic Agents, DNA Mutational Analysis, Female, Humans, Male, Middle Aged, Mutation, Palliative Care, Quality of Life, Genes, ras, Colorectal Neoplasms, Disease Progression, Kaplan-Meier Estimate, Antibodies, Monoclonal, Humanized, ErbB Receptors
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