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Imatinib for the treatment of patients with unresectable or metastatic malignant KIT-positive gastrointestinal stromal tumours : an open-label Belgian trial

Journal Volume 69 - 2006
Issue Fasc.4 - Original articles
Author(s) Hans Prenen, Herlinde Dumez, Cristiana Stefan, Ann Hoeben, Carine Wouters, Marie-Anne Van Lierde, Raf Sciot, Allan T. van Oosterom, Marc Peeters, Marc Polus, Lionel Duck, Thierry Gil, Patrick Schöffski
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(1) Department of General Medical Oncology, Catholic University of Leuven, Leuven Cancer Institute, Leuven, Belgium ; (2) Novartis Pharma Belgium ; (3) Department of Pathology, Catholic University of Leuven, Belgium ; (4) Department of Gastro-enterology, Gent University Hospital, Gent, Belgium ; (5) Department of Gastro-enterol- ogy, Liège University Hospital, Liège, Belgium ; (6) Department of Oncology and Hematology, Clinique Saint-Pierre, Ottignies, Belgium ; (7) Jules Bordet Institute, Brussels, Belgium.

Background : Gastrointestinal stromal tumours (GIST) are the most common mesenchymal tumours of the gastrointestinal tract. They are defined immunohistologically as KIT positive tumours. The only effective treatment for malignant GIST was surgery until 200O.Imatinib mesylate (STI571, Glivec®) has shown substantial anticancer activity in patients with metastatic or unresectable GIST. Patients and methods : 57 patients who were diagnosed with unre- sectable or metastatic malignant GIST were entered into this study. The patients were given 400 mg Glivec orally once daily. The dose could be increased to 600 mg orally once daily and then to 400 mg twice daily if tumour progression was noticed. Daily treatment was interrupted or dose was decreased only in the case of limiting toxi- cities. We evaluated the tumour response and the safety of the drug. Results : 85% of GIST patients showed a partial response or stable disease after 8 weeks of treatment with imatinib. The main side effects were nausea, vomiting, anorexia, skin rash, periorbital oedema and diarrhea. Conclusion : This study confirms that imatinib is an active agent against malignant GIST with manageable toxicities. (Acta gastro- enterol. belg., 2006, 69, 367-371).

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