贝伐单抗在肺癌应用中全程管理.pptVIP

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2019-01-12 发布于浙江
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贝伐单抗在肺癌应用中全程管理.ppt

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2-year OS rate was similar between arms (24.4 vs 21.2 %), however 2-year OS rate for patients who received 维持治疗 was 34.5 vs 26.5 % -Pem+Cb+Bev followed by Pem+ Bev had significantly more study drug-related grade 3/4 anemia, thrombocytopenia, and fatigue compared with Pac+Cb+Bev -Pac+Cb +Bev followed by Bev had significantly more study drug–related grade 3/4 neutropenia, febrile neutropenia, sensory neuropathy, and complete alopecia (grade 2). * * * Research Funding – Yes (Roche, Lilly) (MO22089; NC 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) * 无驱动基因、非鳞癌何时用抗血管生