课件：贝伐单抗在肺癌应用中的全程管理.ppt

Between Dec 3, 2010, and Jan 24, 2013, we screened 1825 patients, of whom 1253 patients were randomly allocated to treatment. Median overall survival was 10·5 months (IQR 5·1-21·2) for 628 patients allocated ramucirumab plus docetaxel and 9·1 months (4·2-18·0) for 625 patients who received placebo plus docetaxel (hazard ratio 0·86, 95% CI 0·75-0·98; p=0·023). Median progression-free survival was 4·5 months (IQR 2·3-8·3) for the ramucirumab group compared with 3·0 months (1·4-6·9) for the control group (0·76, 0·68-0·86; p0·0001). We noted treatment-emergent adverse events in 613 (98%) of 627 patients in the ramucirumab safety population and 594 (95%) of 618 patients in the control safety population. The most common grade 3 or worse adverse events were neutropenia (306 patients [49%] in the ramucirumab group vs 246 [40%] in the control group), febrile neutropenia (100 [16%] vs 62 [10%]), fatigue (88 [14%] vs 65 [10%]), leucopenia (86 [14%] vs 77 [12%]), and hypertension (35 [6%] vs 13 [2%]). The numbers of deaths from adverse events (31 [5%] vs 35 [6%]) and grade 3 or worse pulmonary haemorrhage (eight [1%] vs eight [1%]) did not differ between groups. Toxicities were manageable with appropriate dose reductions and supportive care. * 预计样本量为29例，实际入组32例： ORR阈值31% ORR预期值60.7% 单侧α = 0.05，β = 0.10 * * * * 以BEYOND研究为例，贝伐使用的中位周期数为11个周期，高血压以及蛋白尿的发生率分别为： 高血压：所有级别：16%(贝伐)vs 4%(对照)；3级以上：5%(贝伐)vs 1%(对照) 蛋白尿：所有级别：16%(贝伐)vs 7%(对照)；3级以上：4%(贝伐)vs 0(对照) * 三种治疗模式 EGFR突变阳性人群 Bev+TKI Bev+chemo 一线 二线 EGFR-TKI Bev+chemo EGFR-TKI chemo EGFR-TKI的地位坚不可摧 Rosell, et al. ESMO 2012; Chen, et al. Ann Oncol 2013; Gefitinib SmPC 2010 Han, et al. J Clin Oncol 2012; Mitsudomi, et al. Lancet Oncol 2010; Maemondo, et al. N Engl J Med 2010 Sequist, et al. J Clin Oncol 2013; Wu, et al. ASCO 2013; Wu, et al. WCLC 2013 HANSHIN Oncology Group 0109 贝伐珠单抗+卡铂/紫杉醇用于一线 EGFR TKI治疗失败后 EGFR突变 NSCLC的II期单臂研究 Hattori Y, et al. Lung Cancer 2014 研究设计和患者特征 患者特征 Avastin + CP (n=30) 中位年龄(范围),岁 64 (45–74) 男性 / 女性, %