Update of phase I study of imatinib (STI571) in advanced soft tissue sarcomas and gastrointestinal stromal tumors: a report of the EORTC Soft Tissue and Bone Sarcoma Group

摘要: In a phase I study conducted by the EORTC Soft Tissue and Bone Sarcoma Group, 40 patients with advanced soft tissue sarcomas, most of whom had gastrointestinal stromal tumors (GISTs), received imatinib at doses 400 mg q.d., 300 b.i.d., or 500 b.i.d. Dose-limiting toxicities, including severe nausea, vomiting, edema rash, were seen highest dose level; maximum tolerated was therefore Imatinib active in group 35 GISTs, producing partial responses 19 (54%) stable disease 13 (37%). Responding have now been followed for minimum 10 months. The common side effects continuing on therapy periorbital (40%), peripheral (37.5%), fatigue (30%), skin rash (30%) nausea/vomiting (25%). Severe late myelosuppression has also occasionally. Eighteen (51%) GIST continue to 11 (31%) disease. Thus, 82% GISTs are still obtaining clinically important benefits continued therapy. Some showed accelerated progressive shortly after starting imatinib. On other hand, following drug withdrawal, 2 reductions tumor burden remain alive without summary, is generally well significant activity during long-term treatment GISTs.