晚期NSCLC肺癌治疗全程化管理策略--黄山会议(2014-7-18).pptVIP

* 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 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 * 总结 III期 METLung研究未能证实二/三线治疗MET阳性患者的II期研究结果 增加Onartuzumab无OS, PFS, ORR获益 大部分临床亚组得到一致的结果 根据MET FISH状态，两组也没有OS, PFS, ORR差异 EGFR突变人群中也没有获益 不良事件可耐受，主要为周围性水肿、低白蛋白血症，为MET抑制后的类效应 期待探索性生物标志物分析 Spigel DR, et al. 2014 ASCO Abstract 8000. Nivolumab+厄洛替尼用于EGFR突变的晚期NSCLC患者的安全性和疗效 Rizvi NA, et al. 2014 ASCO Abstract 8022. 分子靶向药物治疗+免疫治疗 Nivolumab （Anti-PD-1) 研究设计 厄洛替尼是FDA批准的一线用于EGFR突变NSCLC的药物，mPFS=10.4个月 Nivolumab单药可改善晚期NSCLC患者的生存 临床前研究显示EGFR通路激活PD-L1表达，EGFR驱动肺癌有免疫逃逸 分析指标：ORR和PFS(RECIST1.1标准) NSCLC IIIB/IV期 EGFR突变 未化疗或TKI进展 N=21 Nivolumab+厄洛替尼 Nivolumab：3 mg/kg iv q2w 厄洛替尼：150 mg/d po PD或 不可耐受毒性 Rizvi NA, et al. 2014 ASCO Abstract 8022. 研究设计