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课件:GIS辅助治疗.ppt
Imatinib was generally well tolerated. Imatinib was generally well tolerated and no unexpected adverse events were seen with the longer treatment duration Most common adverse events reported in the SSGXVIII/AIO trial included anemia, periorbital edema, elevated blood lactate dehydrogenase, fatigue, nausea, diarrhea, leukopenia, and muscle cramps Joensuu H, Eriksson M, Hatrmann J, et al. Twelve versus 36 months of adjuvant imatinib (IM) as treatment of operable GIST with a high risk of recurrence: Final results of a randomized trial (SSGXVIII/AIO). J Clin Oncol. 2011;29(suppl). Abstract LBA1. * * Three years of adjuvant imatinib was well tolerated and significantly improved RFS and OS of GIST patients who have a high estimated risk for recurrence after surgery compared with 1 year of imatinib. The SSGXVIII/AIO trial was the first large Phase III trial that demonstrated that 3 years of adjuvant imatinib treatment, compared with1 year of treatment, can significantly reduce the risk of recurrence and improve OS in patients with KIT-positive GIST at high risk of recurrence The extended duration (3 years) of adjuvant imatinib treatment was well tolerated, and its safety profile was consistent with those previously reported in GIST patients Imatinib is the only therapy to date that has demonstrated a significant OS benefit both in the adjuvant and metastatic settings in patients with GIST Joensuu H, Eriksson M, Hatrmann J, et al. Twelve versus 36 months of adjuvant imatinib (IM) as treatment of operable GIST with a high risk of recurrence: Final results of a randomized trial (SSGXVIII/AIO). J Clin Oncol. 2011;29(suppl). Abstract LBA1. 从肿瘤大小的亚组分析,复发高峰仍是在2年内 size 10cm size 3 and 6 cm size 6cm and 10cm 3 and 6 cm P=0.011 10 cm,P=0.0001 6 and 10 cm P=0.041 根据肿瘤大小把患者分为三组,3 and 6 cm,6 and 10 cm, 10cm组 伊马替尼治疗12个月 一项开放性III期研究 伊马替尼治疗36个月 随访 随访 随机化分配 1:1 分层: 1)R0切除,无肿瘤破裂 2)R1切除或肿瘤破裂 Joensuu H et al. J Clin Oncol. 2011;29(suppl). Abstract LBA1. N=400 SSGXVII
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