一场意料之中的失败
Atezolizumab对比化疗二线SCLC的研究
Introduction
This randomizedphase 2 trial aimed at evaluating the engineered programmed cell death-ligand 1(PD-L1) antibody atezolizumab in small cell lung cancerprogressing after first-line platinum–etoposide chemotherapy.
Methods
2：1随机分配到atezo和化疗组，没有基于PD-L1表达选择
Patients were randomized 2:1 to atezolizumab (1200mg intravenouslyevery 3 weeks) until progression or unacceptable toxicity, or conventionalchemotherapy (up to six cycles of topotecan or re-induction of initialchemotherapy). Patients were not selected based on PD-L1 tissue expression.The primaryendpoint was objective response rate at 6 weeks. A two-stage design with 2:1randomization and O’Brien-Fleming stopping rules was employed. The nullhypothesis was rejected if > 12/45 patients were responders.
Results
Atezo及Chemo组 1）ORR 2.3% vs 10% DCR 20.9% vs 65%；2）PFS 1.4 mo vs 4.3 mo；3） OS 9.8 mo vs 8.7 mo (adjusted HRatezolizumab =0.84 CI: 0.45 ;1.58) ; p=0.60
文章没权限，只从twitter刮了这幅图
Overall, 73patients were randomized (atezolizumab n = 49; chemotherapy n = 24). At 6weeks, 1 of 43 eligible atezolizumab patients achieved an objective response(2.3%, 95% CI 0.0; 6.8), while 8 others had stable disease (20.9% diseasecontrol rate; CI 8.8 ; 33.1). Among eligible chemotherapy patients (n=20), 10%achieved an objective response (65% disease control rate). Median Progression-freesurvival was 1.4 months (CI 1.2; 1.5) with atezolizumab and 4.3 months (CI:1.5; 5.9) with chemotherapy. Overall survival did not significantly differbetween groups: median OS: 9.5 months versus 8.7 months for the atezolizumaband the chemotherapy group, respectively; (adjusted HRatezolizumab =0.84 CI: 0.45 ;1.58) ; p=0.60. Two atezolizumab patients (4.2%) experiencedgrade 3 fatigue, and two others grade 1 dysthyroidism. Among 53 evaluablespecimens, only 1 (2%) had positive immunohistochemical PD-L1 staining (SP142clone).
Conclusions
Atezolizumabmonotherapy in relapsed small cell lung cancer failed to demonstratesignificant efficacy. No unexpected safety concerns were observed.
之前的CM-331【可点击】
再一次说明这种本身OS就几个月的适应症，免疫起效都要1-2mo，OS要提升还是要乘早联用
SCLC的新药治疗，任重道远