胃肠间质瘤课件_1.pptVIP

Patients in both arms had similar clinicopathologic features. The intent-to-treat population included 713 patients, of whom 354 (49.6%) were assigned to the placebo arm and 359 (50.4%) to the imatinib arm Patients were randomized to study treatment at a median of 8.3 weeks after surgical resection Overall, 65 patients did not meet all eligibility requirements for the study (33 patients in the placebo arm and 32 patient in the imatinib arm) DeMatteo RP, Ballman KV, Antonescu CR, et al. Adjuvant imatinib mesylate after resection of localised, primary gastrointestinal stromal tumour: a randomised, double-blind, placebo controlled trial. Lancet. 2009;373:1097–1104. The imatinib and placebo arms of Z9001 had similar clinicopathologic features. The two arms were well-balanced with respect to tumor size, tumor site, and surgical margins The vast majority of patients in Z9001 had undergone R0 resection DeMatteo RP, Ballman KV, Antonescu CR, et al. Adjuvant imatinib mesylate after resection of localised, primary gastrointestinal stromal tumour: a randomised, double-blind, placebo controlled trial. Lancet. 2009;373:1097–1104. Adjuvant imatinib improved 1-year RFS compared with placebo following surgical resection of primary GIST ≥3 cm in size. After a median follow-up of 19.7 months, the estimated 1-year RFS was 98% (95% CI: 96–100) in the imatinib arm compared with 83% in the placebo arm. The overall hazard ratio was 0.35 (95% CI: 0.22–0.35; P0.0001) These findings indicate that imatinib reduced the hazard of tumor recurrence by 65% compared with placebo The rate of recurrence on the imatinib arm appeared to increase after approximately 18 months (i.e. 6 months after completion of study treatment). This raises the possibility that treatment with adjuvant imatinib for longer periods may further extend RFS DeMatteo RP, Ballman KV, Antonescu CR, et al. Adjuvant imatinib mesylate after resection of localised, primary gastrointestinal stromal tumour: a randomised, do