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Annals of Oncology Advance Access originally published online on January 5, 2007
Annals of Oncology 2007 18(4):738-744; doi:10.1093/annonc/mdl460
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© 2007 European Society for Medical Oncology

gastrointestinal tumors

Phase I/II study of preoperative cetuximab, capecitabine, and external beam radiotherapy in patients with rectal cancer

J-P Machiels1,*, C Sempoux1, P Scalliet1, J-C Coche2, Y Humblet1, E Van Cutsem3, J Kerger4, J-L Canon5, M Peeters6, S Aydin1, S Laurent1,6, A Kartheuser1, B Coster7, S Roels8, J-F Daisne9, B Honhon7, L Duck2, C Kirkove10, M-A Bonny1 and K Haustermans8

1 Clinique des Pathologies Tumorales du Côlon et du Rectum, Centre du Cancer, Université catholique de Louvain, Cliniques universitaires Saint-Luc, Brussels
2 Service de Gastroentérologie et d'Oncologie, Clinique St-Pierre, Ottignies
3 Digestive Oncology Unit, Katholieke Universiteit Leuven/University Hospital Gasthuisberg, Leuven
4 Service d'Oncologie, Cliniques universitaires de Mont-Godinne (UCL) and Clinique St-Elisabeth, Namur
5 Service d'Oncologie, Clinique Notre-Dame, Charleroi
6 Digestive Oncology Unit, UZ Gent, Belgium
7 Service d'Oncologie et de Radiothérapie, Hôpital St-Joseph, Gilly
8 Radiation Oncology, Katholieke Universiteit Leuven/University Hospital Gasthuisberg Leuven, Gasthuisberg, Leuven
9 Service de Radiothérapie, Clinique St-Elisabeth, Namur
10 Service de Radiothérapie, Université catholique de Louvain, Cliniques universitaires Saint-Luc, Brussels, Belgium

* Correspondence to: Dr J.-P. Machiels, Medical Oncology Unit, Université catholique de Louvain, Cliniques universitaires Saint-Luc, 10, avenue Hippocrate, 1200 Brussels, Belgium. Tel: 32-2-764-54-85; Fax: 32-2-764-54-28; E-mail: jean-pascal.machiels{at}onco.ucl.ac.be

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 (T3–T4, 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.

Key words: capecitabine, cetuximab, preoperative, radiotherapy, rectal cancer

Received for publication October 21, 2006. Revision received November 5, 2006. Accepted for publication November 7, 2006.


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