ASCO进展回顾__培训课件.ppt

结果显示，对于突变患者，易瑞沙的PFS明显长于化疗。 IPASS研究结果得到了其它临床研究的印证，2009年柳叶刀杂志和2010年新英格兰医学杂志分别全文发表了比较易瑞沙与标准含铂化疗一线治疗EGFR敏感基因突变患者的前瞻性多中心随机III期研究：NEJGSG002研究与WJTOG3405研究，这两项研究的设计相似，都是前瞻性地入组了EGFR基因突变的IIIB/IV期非小细胞肺癌患者，化疗方案分别为卡铂紫杉醇和顺铂多西他赛主要研究终点都是PFS。两项研究的基线特征都均衡可比，男性约30%-40%，吸烟者约30%-40%，绝大多数为腺癌。 两项研究均证实，易瑞沙较化疗显著提高客观缓解率。 * For EGFR mu+ patients, OPTIMAL showed that the similar OS between A and B, how about efficacy comparison for fully cross-over in 1st and 2nd line? FASTACT-II subgroup results suggested C (intermittent) contribute to a significant longer OS than A, but still no evidence for its superiority to the current stand of modality B. SATURN and INFORM showed that D (switch maintenance) is superior to A in OS, but does it better than B or C? Is it possible for concurrent modality E in this selected population ? * The aim of this study is to investigate the efficacy of adjuvant FOLFOX for LARC pts who underwent Fp-based Pre-CRT and complete total mesorectal excision (TME). Methods: This randomised phase II study accrued LARC pts whose ypStage was II, (ypT3-4/ypN0) or III (any ypT/ypN1-2) after Fp-based Pre-CRT followed by TME. Pts were randomly assigned (1:1) to receive adjuvant chemotherapy either with FL (5-FU 380 mg/m2, leucovorin 20 mg/m2 on D1-5 q 4 weeks X 4 cycles) or FOLFOX (oxaliplatin 85 mg/m2, leucovorin 200 mg/m2 on D1, 5-FU bolus 400 mg/m2 on D1, 5-FU infusion 2400 mg/m2 for 46 hours q 2 weeks X 8 cycles). The primary endpoint was disease-free survival (DFS). Results * The aim of this study is to investigate the efficacy of adjuvant FOLFOX for LARC pts who underwent Fp-based Pre-CRT and complete total mesorectal excision (TME). Methods: This randomised phase II study accrued LARC pts whose ypStage was II, (ypT3-4/ypN0) or III (any ypT/ypN1-2) after Fp-based Pre-CRT followed by TME. Pts were randomly assigned (1:1) to receive adjuvant chemotherapy either with FL (5-FU 380 mg/m2, leucovorin 20 mg/m2 on D1-5 q 4 weeks X 4 cycles) or FOLFOX (oxaliplatin 85 mg/m2, leucovorin