Stromal Tumours （GIST） Imedex LLC胃肠道间质瘤（GIST） 课件.ppt

* * * * * The primary objective of this randomized, phase 3 European Organisation for Research and Treatment of Cancer (EORTC) 62024 study is to assess the time to imatinib failure in intermediate-risk and high-risk patients who had undergone complete resection of GIST and received 2 years of adjuvant imatinib In this study, patients were randomized to adjuvant imatinib 400 mg/day or observation The primary endpoint is TTSR The original primary endpoint was OS but was changed to obtain evaluable data as early as possible Secondary objectives included assessment of overall survival, relapse-free interval, and safety European Organisation for Research and Treatment of Cancer. Imatinib mesylate or observation only in treating patients who have undergone surgery for localized gastrointestinal stromal tumour. /ct/show/NC Accessed July 31, 2009. * The EORTC 62024 trial is being conducted in patients who have undergone surgery for localized GIST and are at intermediate risk or high risk of relapse High risk of relapse is defined as tumour size 10 cm, mitotic rate 10/50 HPF, or tumour size 5 cm and mitotic rate 5/50 HPF. Intermediate risk is defined as tumour size 5 cm and mitotic rate 6–10/50 HPF, or tumour size 5–10 cm and mitotic rate 5/50 HPF After the 2-year treatment period, patients were followed every 3 months for 2 years. Following the 2-year period, all patients were followed every 4 months for 3 years, then annually thereafter Primary objective is TTSR Secondary objectives are RFS, OS, and safety Inclusion criteria are: Intermediate-risk or high-risk GIST Completely resected KIT-positive GIST Patients are stratified according to: Risk category (high vs intermediate) tumour site (gastric vs other) Resection level (R0 vs R1) European Organisation for Research and Treatment of Cancer. Imatinib mesylate or observation only in treating patients who have undergone surgery for localized gastrointestinal stromal tumour. /ct/show/NC Accessed A