Huang Jiaxing, Zhang Yaxiong, Sheng Jin, Zhang Hongyu, Fang Wenfeng, Zhan Jianhua, Zhou Ting, Chen Ying, Liu Lin, Zhang Li
Department of Medical Oncology, Sun Yat-Sen University Cancer Center; State Key Laboratory of Oncology in South China.
Department of Medical Oncology, the Fifth Affiliated Hospital of Sun Yat-Sen University, Zhuhai, Guangdong, People's Republic of China.
Onco Targets Ther. 2016 Sep 23;9:5867-5874. doi: 10.2147/OTT.S115262. eCollection 2016.
Nivolumab (BMS-936558/ONO-4538) was the first monoclonal antibody targeting programmed death (PD)-1. So far, a number of clinical trials on nivolumab have showed satisfactory efficacy in treating non-small-cell lung cancer (NSCLC). Herein, we present a meta-analysis evaluating the efficacy and safety of nivolumab for previously treated advanced NSCLC patients.
Electronic databases were searched for eligible literature. Data of objective response rate (ORR), disease control rate, overall survival, progression-free survival, and adverse effects (AEs) were extracted and pooled. Outcomes analyzed and presented in this study were according to the original data from nivolumab 3 mg/kg.
In general, nine trials with 817 patients were included in this meta-analysis. The pooled ORR, disease control rate, 1-year overall survival rate, and 1-year progression-free survival rate were 20% (95% confidence interval [CI]: 17%-23%), 36% (95% CI: 22%-51%), 47% (95% CI: 40%-53%), 21% (95% CI: 18%-24%), respectively. In addition, the rate of grade 3-4 AEs was only 8% (95% CI: 6%-12%). Subgroup analysis showed no significant difference in terms of ORR between squamous and non-squamous NSCLC (odds ratio 1.23, 95% CI: 0.63-2.39, =0.51). However, significantly greater ORR was presented in programmed cell death ligand 1 (PD-L1) positive cohort (ORR 31%, 95% CI: 24%-38%), compared to PD-L1 negative cohort (ORR 12%, 95% CI: 9%-17%). The odds ratio for objective response to nivolumab in PD-L1 positive cases relative to negative cases was 3.08 (95% CI: 1.87-5.08, <0.0001).
In conclusion, nivolumab is a promising second-line agent for previously treated advanced NSCLC with manageable AEs. Both squamous and non-squamous NSCLC patients showed similar efficacy. In addition, patients with positive PD-L1 expression had better response from nivolumab.
We present a meta-analysis evaluating the efficacy and safety of nivolumab for previously treated advanced NSCLC patients. In our study, nivolumab is a promising second-line agent for previously treated advanced NSCLC with manageable AEs. Both squamous and non-squamous NSCLC patients showed similar efficacy. In addition, patients with positive PD-L1 expression had better response from nivolumab.
纳武利尤单抗（BMS-936558/ONO-4538）是首个靶向程序性死亡（PD）-1的单克隆抗体。迄今为止，多项关于纳武利尤单抗的临床试验已显示出在治疗非小细胞肺癌（NSCLC）方面令人满意的疗效。在此，我们进行一项荟萃分析，评估纳武利尤单抗用于既往接受过治疗的晚期NSCLC患者的疗效和安全性。
检索电子数据库以获取符合条件的文献。提取并汇总客观缓解率（ORR）、疾病控制率、总生存期、无进展生存期及不良反应（AE）的数据。本研究分析和呈现的结果依据纳武利尤单抗3mg/kg的原始数据。
总体而言，本荟萃分析纳入了9项试验共817例患者。汇总的ORR、疾病控制率、1年总生存率及1年无进展生存率分别为20%（95%置信区间[CI]：17%-23%）、36%（95%CI：22%-51%）、47%（95%CI：40%-53%）、21%（95%CI：18%-24%）。此外,3-4级AE的发生率仅为8%（95%CI：6%-12%）。亚组分析显示，鳞状和非鳞状NSCLC在ORR方面无显著差异（优势比1.23，95%CI：0.63-2.39，P=0.51）。然而，与程序性死亡配体1（PD-L1）阴性队列（ORR 12%，95%CI：9%-17%）相比，PD-L1阳性队列（ORR 31%，95%CI：24%-38%）的ORR显著更高。PD-L1阳性病例相对于阴性病例对纳武利尤单抗客观缓解的优势比为3.08（95%CI：1.87-5.08，P<0.0001）。
总之，纳武利尤单抗是一种有前景的二线治疗药物，用于既往接受过治疗的晚期NSCLC患者，且AE可控。鳞状和非鳞状NSCLC患者均显示出相似的疗效。此外，PD-L1表达阳性的患者对纳武利尤单抗的反应更好。
我们进行一项荟萃分析，评估纳武利尤单抗用于既往接受过治疗的晚期NSCLC患者的疗效和安全性。在我们的研究中，纳武利尤单抗是一种有前景的二线治疗药物，用于既往接受过治疗的晚期NSCLC患者，且AE可控。鳞状和非鳞状NSCLC患者均显示出相似的疗效。此外，PD-L1表达阳性的患者对纳武利尤单抗的反应更好。
