Prospective Multicentric Randomized Study of Glivec in Advanced GIST Expressing C-kit: Interruption After 5 Years vs Maintenance

Gastrointestinal stromal tumors (GISTs) are associated with a dismal prognosis in localized and advanced phase with a major resistance to conventional chemotherapy agents. Virtually all malignant GISTs actually harbor activating mutations of the KIT pathway in the tumor cells, leading to ligand-independent activation of KIT tyrosine kinase activity and tumor growth in vitro. Glivec inhibits KIT and exerts a major antitumor efficacy in vivo in patients with advanced GIST. Glivec is generally pursued until progression or intolerance. The optimal duration of treatment with Glivec remains unknown. The objective of this study is to determine the feasibility of Glivec treatment interruption with reintroduction at progression in GIST patients.