Cited by 1,694Colorectal Cancer Treatments and StudiesHER2/EGFR in Cancer ResearchLung Cancer Treatments and Mutations

Phase II Trial of Cetuximab in Patients With Refractory Colorectal Cancer That Expresses the Epidermal Growth Factor Receptor

Saltz, Leonard B., Meropol, Neal J., Loehrer, Patrick J., Needle, Michael N., Kopit, Justin, Mayer, Robert J.·2004·Journal of Clinical Oncology

Abstract

Purpose: To evaluate the antitumor activity and toxicity of single-agent cetuximab in patients with chemotherapy-refractory colorectal cancer whose tumors express the epidermal growth factor receptor. Patients and Methods: Phase II, open-label clinical trial. Patients were required to have EGFr expression demonstrated on formalin-fixed paraffin-embedded tumor tissue by immunohistochemical staining before study participation. Patients were required to have received irinotecan, either alone or in a combination regimen, and to have demonstrated clinical failure on this regimen before study entry. Cetuximab was administered weekly by intravenous infusion. The first dose of 400 mg/m 2 was given during the course of 2 hours. Subsequent weekly treatments were given at a dose of 250 mg/m 2 during the course of 1 hour. Results: Fifty-seven eligible patients were treated. All were assessable for toxicity and response. The most commonly encountered grade 3 to 4 adverse events, regardless of relationship to study drug, were an acne-like skin rash, predominantly on the face and upper torso (86% with any grade; 18% with grade 3), and a composite of asthenia, fatigue, malaise, or lethargy (56% with any grade, 9% with grade 3). Two patients (3.5%) experienced grade 3 allergic reactions requiring discontinuation of study treatment. A third patient experienced a grade 3 allergic reaction that resolved, and the patient continued on the study. Neither diarrhea nor neutropenia were dose limiting in any of the 57 patients treated. Five patients (9%; 95% CI, 3% to 19%) achieved a partial response. Twenty-one additional patients had stable disease or minor responses. The median survival in these previously treated patients with chemotherapy-refractory colorectal cancer is 6.4 months. Conclusion: Cetuximab on this once-weekly schedule has modest activity and is well-tolerated as a single agent in patients with chemotherapy-refractory colorectal cancer whose tumors express the epidermal growth factor receptor. Further studies of cetuximab will evaluate the use of cetuximab in conjunction with first-line and adjuvant treatments for this disease.

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Crossref · 10.1200/jco.2004.10.182

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33 of 33 references verified0 citation errors · 0 not checkable

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  • Anti-EGFR antibodies cetuximab and panitumumab are approved for treatment of RAS/RAF wild type CRC, while EGFR tyrosine kinase inhibitors are approved for treatment of EGFR mutant lung cancer.

    “The anti-EGFR antibodies cetuximab and panitumumab are approved for the treatment of RAS/RAF wild type CRC(34, 35), while EGFR tyrosine kinase inhibitors (TKI) are approved for the treatment of EGFR mutant lung cancer(36).”
  • The 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”
  • Cetuximab sensitizes the KRAS (G12C) CRC cells to AMG510, and the combination restores secondary resistance to anti-EGFR antibodies.

    “Cetuximab sensitizes the KRAS (G12C) CRC cells to AMG510, and the combination restores secondary resistance to anti-EGFR antibodies.”

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Authors
Saltz, L. B., Meropol, N. J., Loehrer, P. J., Needle, M. N., Kopit, J., & Mayer, R. J.
Affiliations
Fox Chase Cancer Center (US)
Venue
Journal of Clinical Oncology
Published
2004-04-01
Volume
22
Issue
7
Pages
1201-1208
ISSN
  • 0732-183X (ISSN-L)
  • 1527-7755
OpenAlex
W2168377135
Cited by
1,694
References
33
Citations by year
2026: 2 · 2025: 10 · 2024: 16 · 2023: 19 · 2022: 18 · 2021: 25 · 2020: 28 · 2019: 24 · 2018: 25 · 2017: 36 · 2016: 45 · 2015: 59 · 2014: 75 · 2013: 90 · 2012: 92
FWCI
93.04
Type
journal article
Language
en
Open access
closed
Locations
  • Journal of Clinical Oncology (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Oncology › Colorectal Cancer Treatments and Studies
  • Health Sciences › Medicine › Oncology › HER2/EGFR in Cancer Research
  • Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
Keywords
cetuximab, colorectal cancer, epidermal growth factor receptor, chemotherapy-refractory cancer, irinotecan, monotherapy, anticancer activity, drug toxicity, acne-like rash, allergic reactions, survival
MeSH terms
Cetuximab, Adult, Aged, Aged, 80 and over, Antibodies, Monoclonal, Antineoplastic Agents, Female, Humans, Immunotherapy, Infusions, Intravenous, Male, Middle Aged, Colorectal Neoplasms, Survival Rate, Treatment Outcome, Antibodies, Monoclonal, Humanized, ErbB Receptors

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