One vs Three Years of Adjuvant Imatinib for Operable Gastrointestinal Stromal Tumor

摘要: Context Adjuvant imatinib administered for 12 months after surgery has improved recurrence-free survival (RFS) of patients with operable gastrointestinal stromal tumor (GIST) compared placebo. Objective To investigate the role administration duration as adjuvant treatment who have a high estimated risk GIST recurrence surgery. Design, Setting, and Patients KIT-positive removed at were entered between February 2004 September 2008 to this randomized, open-label phase 3 study conducted in 24 hospitals Finland, Germany, Norway, Sweden. The was using modified National Institutes Health Consensus Criteria. Intervention Imatinib, 400 mg per day, orally either or 36 months, started within weeks Main Outcome Measures primary end point RFS; secondary points included overall safety. Results Two hundred allocated each group. median follow-up time randomization 54 December 2010. Diagnosis confirmed 382 397 (96%) intention-to-treat population central pathology review. KIT PDGFRA mutation detected 333 366 tumors (91%) available testing. assigned had longer RFS those (hazard ratio [HR], 0.46; 95% CI, 0.32-0.65; P  Conclusion Compared imatinib, recurrence. Trial Registration clinicaltrials.gov Identifier: NCT00116935