Background: This study aimed to estimate the relative efficacy of neoadjuvant nivolumab in combination with chemotherapy (neoNIVO + CT) compared to relevant treatments amongst resectable non-metastatic non-small-cell lung cancer (rNSCLC) patients. Methods: Treatment comparisons were based on a network meta-analysis (NMA) using randomized clinical trial data identified via systematic literature review (SLR). The outcomes of interest were event-free survival (EFS) and pathological complete response (pCR). NeoNIVO + CT was compared to neoadjuvant chemotherapy (neoCT), neoadjuvant chemoradiotherapy (neoCRT), adjuvant chemotherapy (adjCT), and surgery alone (S). Due to the potential for effect modification by stage, all-stage and stage-specific networks were considered. Fixed-effect (FE) and random-effects Bayesian NMA models were run (EFS = hazard ratios [HR]; pCR = odds ratios [OR]; 95% credible intervals [CrI]). Results: Sixty-one RCTs were identified (base case = 9 RCTs [n= 1978 patients]). In the all-stages FE model, neoNIVO + CT had statistically significant EFS improvements relative to neoCT (HR = 0.68 [95% CrI: 0.49, 0.94]), S (0.59 [0.42, 0.82]), adjCT (0.66 [0.45, 0.96]), but not relative to neoCRT (HR = 0.77 [0.52, 1.16]). NeoNIVO + CT (5 RCTs) had statistically significant higher odds of pCR relative to neoCT (OR = 12.53 [5.60, 33.82]) and neoCRT (7.15 [2.31, 24.34]). Stage-specific model findings were consistent. CONCLUSIONS: This NMA signals improved EFS and/or pCR of neoNIVO + CT relative to comparators among patients with rNSCLC.
背景:本研究旨在评估纳武利尤单抗联合化疗新辅助治疗(neoNIVO + CT)相较于相关治疗方案在可切除非转移性非小细胞肺癌(rNSCLC)患者中的相对疗效。方法:通过系统性文献综述识别随机临床试验数据,采用网状荟萃分析进行治疗方案比较。关注结局指标为无事件生存期和病理学完全缓解率。将neoNIVO + CT与新辅助化疗、新辅助放化疗、辅助化疗及单纯手术进行对比。考虑到分期可能产生的效应修饰作用,构建了全分期及分期特异性网络模型。采用固定效应与随机效应贝叶斯网状荟萃分析模型进行分析。结果:共纳入61项随机对照试验。在全分期固定效应模型中,neoNIVO + CT相较于新辅助化疗、单纯手术及辅助化疗均显示出具有统计学显著性的无事件生存期改善,但相较于新辅助放化疗未达统计学显著性。在病理学完全缓解率方面,neoNIVO + CT相较于新辅助化疗及新辅助放化疗均呈现显著优势。分期特异性模型结果与全分期模型一致。结论:本网状荟萃分析表明,在可切除非小细胞肺癌患者中,纳武利尤单抗联合化疗新辅助治疗方案相较于对照治疗方案能改善无事件生存期和/或提高病理学完全缓解率。