The DOI matches its Crossref record; 32 of the 32 references it cites were found in a registry or an index.
Phase I Study of Anti–Epidermal Growth Factor Receptor Antibody Cetuximab in Combination With Radiation Therapy in Patients With Advanced Head and Neck Cancer
Abstract
PURPOSE: To evaluate the safety, pharmacokinetics, and efficacy of a chimeric anti–epidermal growth factor receptor monoclonal antibody, cetuximab, in combination with radiation therapy (RT) in patients with advanced squamous cell carcinoma of the head and neck. PATIENTS AND METHODS: We treated 16 patients in five successive treatment schedules. A standard dose escalation procedure was used; three patients entered onto the study at each dose level of cetuximab received conventional RT (70 Gy, 2 Gy/d), and the final three patients received hyperfractionated RT (76.8 Gy, 1.2 Gy bid). Cetuximab was delivered as a loading dose of 100 to 500 mg/m 2, followed by weekly infusions of 100 to 250 mg/m 2 for 7 to 8 weeks. Circulating levels of cetuximab during therapy were determined using a biomolecular interaction analysis core instrument. Human antichimeric antibody response was evaluated with a double-antigen radiometric assay. The recommended phase II/III dose was defined as the optimal cetuximab dose level based on the pharmacologic parameters and adverse events. RESULTS: The most commonly reported adverse events were fever, asthenia, transaminase elevation, nausea, and skin toxicities (grade 1 to 2 in most patients). Skin toxicity outside of the RT field was not strictly dose-dependent; however, grade 2 or higher events were observed in patients treated with higher dose regimens. There was one grade 4 allergic reaction. Most acute adverse effects were associated with RT (xerostomia, mucositis, and local skin toxicity). No antibodies against cetuximab were detected. All patients achieved an objective response (13 complete and two partial remissions). CONCLUSION: Cetuximab can be safely administered with RT. The recommended dose for phase II/III studies is a loading dose of 400 to 500 mg/m 2 and a maintenance weekly dose of 250 mg/m 2.
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Cites
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Status of Epidermal Growth Factor Receptor Antagonists in the Biology and Treatment of Cancer
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Understanding resistance to EGFR inhibitors—impact on future treatment strategies
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Population Pharmacokinetics of Therapeutic Monoclonal Antibodies
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Antibody-Dependent Cellular Cytotoxicity Mediated by Cetuximab against Lung Cancer Cell Lines
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Metadata
- Authors
- Robert, F., Ezekiel, M. P., Spencer, S. A., Meredith, R. F., Bonner, J. A., Khazaeli, M. B., Saleh, M. N., Carey, D., LoBuglio, A. F., Wheeler, R. H., Cooper, M. R., & Waksal, H. W.
- Venue
- Journal of Clinical Oncology
- Published
- 2001-07-01
- Volume
- 19
- Issue
- 13
- Pages
- 3234-3243
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2167531081
- Cited by
- 474
- References
- 32
- FWCI
- 43.91
- Type
- journal article
- Language
- en
- Open access
- closed
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- Robert, F., Ezekiel, M. P., Spencer, S. A., Meredith, R. F., Bonner, J. A., Khazaeli, M. B., Saleh, M. N., Carey, D., LoBuglio, A. F., Wheeler, R. H., Cooper, M. R., & Waksal, H. W. (2001). Phase I Study of Anti–Epidermal Growth Factor Receptor Antibody Cetuximab in Combination With Radiation Therapy in Patients With Advanced Head and Neck Cancer. Journal of Clinical Oncology. https://doi.org/10.1200/jco.2001.19.13.3234
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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
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