immuno-oncological (io) therapies such as pd-1 and pd-l1 antibodies have been introduced in the treatment of advanced non-small cell lung cancer (nsclc) since 2015 based on randomized trials showing unprecedented advantages in overall survival (os) with hazard ratios (hrs) between 0.5 and 0.7. the impact of these treatments on os in routine clinical practice and the role of tumor mass have not been studied.
557 consecutive patients with inoperable stage iii or stage iv nsclc diagnosed in our certified lung cancer center from 2006 to 2018 were included if they had received at least one line of systemic treatment. os of immuno-oncologically treated patients (io patients, n = 144) who received treatment with a pd-1 antibody (nivolumab [n = 77] or pembrolizumab [n = 51]) or a pd-l1 antibody (atezolizumab [n = 4] or durvalumab [n = 12]) was compared to historic controls treated before availability of io treatment (n = 413) using case-control analysis. io patients and historic controls were individually matched for stage, performance state, histology, smoking status, gender, age, and initial treatment mode (palliative vs. definitive radio-chemotherapy).
2006-2018年间，连续纳入557例在我肺癌注册中心诊断为不可手术的iii期或iv期nsclc患者，他们至少接受了一种系统性治疗。采用病例对照分析对接受pd-1抗体(nivolumab [n = 77] 或 pembrolizumab [n = 51])或pd-l1抗体(atezolizumab [n = 4] 或 durvalumab [n = 12])免疫肿瘤治疗的患者（io患者，n = 144）与可以接受io治疗之前进行历史对照治疗患者（n = 413）的os进行对比。io患者组和历史对照组在分期、功能状态、组织学、吸烟情况、性别、年龄和初始治疗方式(姑息治疗 vs. 最终的放化疗)上进行了单独匹配。
case-control analysis of 91 matched pairs showed significantly longer os in io patients compared to historic controls (21.2 vs. 10.9 months, hr 0.526, ci 0.373-0.723). the benefit was more pronounced in patients with lower tumor stage (hr 0.48 [stage iii], 0.40 [iva], 0.63 [ivb]) or smaller tumor size (hr 0.38 [recist ≤57 mm], 0.40 [recist 58-94 mm], 0.59 [recist 95-141 mm], 0.75 [recist ≥142 mm]).
91对配对的病例对照分析显示，io患者的os明显长于历史对照组(21.2个月vs. 10.9个月，hr 0.526, ci 0.373-0.723)。此种获益在肿瘤分期较低(hr 0.48 [iii期], 0.40 [iva], 0.63 [ivb])或肿瘤较小(hr 0.38 [recist ≤57 mm], 0.40 [recist 58-94 mm], 0.59 [recist 95-141 mm], 0.75 [recist ≥142 mm])的患者中更为显著。
io patients showed significant benefit in os with hrs comparable to those reported in phase iii trials. the benefit tended to be greater in patients with lower tumor mass.