Cited by 3,207Colorectal Cancer Treatments and StudiesLung Cancer Treatments and MutationsHER2/EGFR in Cancer Research

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Wild-Type KRAS Is Required for Panitumumab Efficacy in Patients With Metastatic Colorectal Cancer

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Amado, Rafael G., Wolf, Michael, Peeters, Marc, Van Cutsem, Eric, Siena, Salvatore, Freeman, Daniel J., Juan, Todd, Sikorski, Robert, Suggs, Sid, Radinsky, Robert, Patterson, Scott D., Chang, David D.·2008·Journal of Clinical Oncology

DOI 10.1200/jco.2007.14.7116

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Abstract

Purpose: Panitumumab, a fully human antibody against the epidermal growth factor receptor (EGFR), has activity in a subset of patients with metastatic colorectal cancer (mCRC). Although activating mutations in KRAS, a small G-protein downstream of EGFR, correlate with poor response to anti-EGFR antibodies in mCRC, their role as a selection marker has not been established in randomized trials. Patients and Methods: KRAS mutations were detected using polymerase chain reaction on DNA from tumor sections collected in a phase III mCRC trial comparing panitumumab monotherapy to best supportive care (BSC). We tested whether the effect of panitumumab on progression-free survival (PFS) differed by KRAS status. Results: KRAS status was ascertained in 427 (92%) of 463 patients (208 panitumumab, 219 BSC). KRAS mutations were found in 43% of patients. The treatment effect on PFS in the wild-type (WT) KRAS group (hazard ratio [HR], 0.45; 95% CI: 0.34 to 0.59) was significantly greater (P < .0001) than in the mutant group (HR, 0.99; 95% CI, 0.73 to 1.36). Median PFS in the WT KRAS group was 12.3 weeks for panitumumab and 7.3 weeks for BSC. Response rates to panitumumab were 17% and 0%, for the WT and mutant groups, respectively. WT KRAS patients had longer overall survival (HR, 0.67; 95% CI, 0.55 to 0.82; treatment arms combined). Consistent with longer exposure, more grade III treatment-related toxicities occurred in the WT KRAS group. No significant differences in toxicity were observed between the WT KRAS group and the overall population. Conclusion: Panitumumab monotherapy efficacy in mCRC is confined to patients with WT KRAS tumors. KRAS status should be considered in selecting patients with mCRC as candidates for panitumumab monotherapy.

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Authors: Amado, R. G., Wolf, M., Peeters, M., Van Cutsem, E., Siena, S., Freeman, D. J., Juan, T., Sikorski, R., Suggs, S., Radinsky, R., Patterson, S. D., & Chang, D. D.
Affiliations: Ghent University Hospital (BE)
Amgen (United States) (US)
From Amgen Inc, Thousand Oaks, CA; Ghent University Hospital, Ghent, Belgium; University Hospital Gasthuisberg, Leuven, Belgium; and the Ospedale Niguarda Ca’ Granda, Milan, Italy
ORCID: Amado, Rafael G.
Peeters, Marc
Siena, Salvatore
Patterson, Scott D.
Chang, David D.
Venue: Journal of Clinical Oncology
Publisher: American Society of Clinical Oncology (ASCO)
Published: 2008-04-01
Volume: 26
Issue: 10
Pages: 1626-1634
ISSN: 0732-183X (ISSN-L)
1527-7755
DOI: 10.1200/jco.2007.14.7116
OpenAlex: W2106789440
Cited by: 3,207
References: 38
Citations by year: 2026: 32 · 2025: 48 · 2024: 59 · 2023: 77 · 2022: 112 · 2021: 123 · 2020: 106 · 2019: 135 · 2018: 131 · 2017: 163 · 2016: 181 · 2015: 253 · 2014: 280 · 2013: 254 · 2012: 288
FWCI: 169.59
Type: journal article
Language: en
Update notices: new_edition (2023-06-14)
Open access: bronze
doi.org
Locations: Journal of Clinical Oncology (publishedVersion)
PubMed (publishedVersion)
Archivio Istituzionale della Ricerca (Universita Degli Studi Di Milano) (submittedVersion, other-oa)
Ghent University Academic Bibliography (Ghent University) (submittedVersion)
Funders: Amgen
Topics: Health Sciences › Medicine › Oncology › Colorectal Cancer Treatments and Studies
Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
Health Sciences › Medicine › Oncology › HER2/EGFR in Cancer Research
Keywords: panitumumab, KRAS wild-type, KRAS mutation, metastatic colorectal cancer, anti-EGFR therapy, epidermal growth factor receptor, biomarker selection, progression-free survival, best supportive care, treatment toxicity, patient selection
MeSH terms: Panitumumab, Adult, Aged, Aged, 80 and over, Antibodies, Monoclonal, Antineoplastic Agents, Female, Humans, Male, Middle Aged, Mutation, Proto-Oncogene Proteins, Biomarkers, Tumor, Colorectal Neoplasms, Polymerase Chain Reaction, Proto-Oncogene Proteins p21(ras), Disease-Free Survival, ras Proteins, Drug Resistance, Neoplasm, Kaplan-Meier Estimate

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Wild-Type KRAS Is Required for Panitumumab Efficacy in Patients With Metastatic Colorectal Cancer

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