原发GIST的治疗.pptVIP

* Note: The data you will be using during sales calls is based on the ITT population, NOT the interim ITT population. 713 patients were analyzed in the ITT population. 1[CSRZ9001, 44table 11-5] The analysis of the ITT population supported the primary endpoint results from the interim ITT population. 1[CSRZ9001, 43b] 98% of imatinib-treated patients maintained recurrence-free survival at 12 months, compared to 82% of placebo-treated patients. 1[CSRZ9001, 44table 11-5] The risk of recurrence was reduced by 89% in patients treated with imatinib (P 0.0001). 1[CSRZ9001, 54table 11-11] After 2 years, 90% of patients maintained recurrence-free survival. 1[CSRZ9001, 44table 11-5] Reference: Heintz D, Green S, Boulaire JM. A phase III, randomized, double-blind study of adjuvant STI571 (Gleevec?) versus placebo in patients following the resection of primary gastrointestinal stromal tumor (GIST). Novartis Pharmaceuticals. 2007;ACOSOGZ9001/STI571BUS89:1-76. 多个临床试验结果显示: 辅助治疗能够降低复发风险 辅助治疗的适应人群:中高复发风险的患者 辅助治疗的时间:不同复发风险区别对待 * 多个临床试验结果显示: 辅助治疗能够降低复发风险 辅助治疗的适应人群:中高复发风险的患者 辅助治疗的时间:不同复发风险区别对待 * * Background: Imatinib benefits the patients with metastatic GIST but whether it is effective in the adjuvant setting after complete tumor resection of primary GIST is questionable. Methods: Patients who had undergone complete tumor resection with intermediate or high risk of recurrence (define) were enrolled in a single-center non-randomized open contrast study. Patients had adjuvant therapy with imatinib (400mg once a day) for 3 years commencing within 12 weeks of tumor resection, or had follow-up alone. We performed c-kit and PDGFRA mutation analysis for patients with archival tumor samples. The primary objective was recurrence-free survival (RFS) and the second objective was correlation of gene mutation profile with efficacy of adjuvant therapy. Results: One hundred and five patients were enrolled: 56 patients in adjuvant therapy group and 49 patients in control group. Median