晚期NSCLC肺癌治疗全程化管理策略__黄山会议(2014_7_18).ppt

* * * 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 * 发生率?15%的不良事件 Spigel DR, et al. 2014 ASCO Abstract 8000. 安慰剂+厄洛替尼 (n=244) Onartuzumab+厄洛替尼 (n=248) 所有级别 (%) 3-4级 (%) 所有级别 (%) 3-4级 (%) 皮疹 37 5 39 8 腹泻 47 4 39 3 痤疮样皮炎 26 3 32 4 食欲下降 32 3 29 0.8 恶心 26 3 28 2 乏力 30 5 27 4 外周水肿 8 0 22 0.8 呼吸困难 19 5 22 5 皮肤干燥 22 0 20 0.4 低白蛋白血症 4 0 17 4 呕吐 15 0 15 0.4 咳嗽 22 0 14 0 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