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Title
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Phase I/II study of preoperative cetuximab, capecitabine, and external beam radiotherapy in patients with rectal cancer
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Author
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Abstract
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| Background: To assess the safety and preliminary efficacy of concurrent radiotherapy, capecitabine, and cetuximab in the preoperative treatment of patients with rectal cancer. Patients and methods: Forty patients with rectal cancer (T3T4, and/or N+, endorectal ultrasound) received preoperative radiotherapy (1.8 Gy, 5 days/week for 5 weeks, total dose 45 Gy, three-dimensional conformal technique) in combination with cetuximab [initial dose 400 mg/m2 intravenous given 1 week before the beginning of radiation followed by 250 mg/m2/week for 5 weeks] and capecitabine for the duration of radiotherapy (650 mg/m2 orally twice daily, first dose level; 825 mg/m2 twice daily, second dose level). Results: Four and six patients were treated at the first and second dose level of capecitabine, respectively. No dose-limiting toxicity occurred. Thirty additional patients were treated with capecitabine at 825 mg/m2 twice daily. The most frequent grade 1/2 side-effects were acneiform rash (87%), diarrhea (65%), and fatigue (57%). Grade 3 diarrhea was found in 15%. Three grade 4 toxic effects were recorded: one myocardial infarction, one pulmonary embolism, and one pulmonary infection with sepsis. Two patients (5%) had a pathological complete response. Conclusions: Preoperative radiotherapy in combination with capecitabine and cetuximab is feasible with some patients achieving pathological downstaging. |
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Language
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English
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Source (journal)
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Annals of oncology / European Society for Medical Oncology. - Amsterdam
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Publication
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Amsterdam
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2007
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ISSN
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0923-7534
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DOI
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10.1093/ANNONC/MDL460
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Volume/pages
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18
:4
(2007)
, p. 738-744
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ISI
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000245349500019
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Full text (Publisher's DOI)
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Full text (publisher's version - intranet only)
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