Department of Pharmacy, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.
Department of Pharmacy, The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.
Cancer Med. 2021 Sep;10(18):6344-6353. doi: 10.1002/cam4.4191. Epub 2021 Aug 12.
BACKGROUND AND OBJECTIVE: The programmed death 1 and ligand (PD-1/PD-L1) inhibitors have significantly altered therapeutic perspectives on non-small-cell lung cancer (NSCLC). However, their efficacy and safety are unknown since direct clinical trials have not yet been performed on them. It is also necessary to determine the economics of PD-1/PD-L1 inhibitors due to their high cost. The aim was to evaluate the efficacy, safety, and cost-effectiveness of PD-1/PD-L1 inhibitor monotherapy for advanced NSCLC patients in China with high PD-L1 expression as first-line treatment. METHODS: From the PubMed, Cochrane, and Web of Science databases, we retrieved survival, progression, and safety data on PD-1/PD-L1 inhibitor monotherapy for advanced NSCLC patients. A network meta-analysis (NMA) was performed to consider PD-1/PD-L1 inhibitors in efficacy and safety. A Markov model with a full-lifetime horizon was adopted. Clinical and utility data were collected through the trial. The cost per quality-adjusted life year (QALY) was as incremental cost-effectiveness ratio (ICER). Sensitivity analyses were performed. RESULTS: This study included five phase III clinical trials using four drugs: nivolumab, pembrolizumab, atezolizumab, and durvalumab. The NMA demonstrated that the four drugs had similar efficacy and safety, while pembrolizumab and atezolizumab were better for than for nivolumab (hazard ratio (HR) = 0.66, 95% confidence intervals (CIs): 0.46-0.95 and HR = 0.59, 95%CI: 0.37-0.94) in progression-free survival (PFS), and the risk of a severe adverse event was higher for atezolizumab than for nivolumab and pembrolizumab. Compared with nivolumab, durvalumab, pembrolizumab, and atezolizumab had QALY of 0.19, 0.38, and 0.53, respectively, which induced ICERs of $ 197,028.8/QALY, $ 111,859.0/QALY, and $ 76,182.3/QALY, respectively. CONCLUSION: The efficacy and safety are similar among types of PD-1/PD-L1-inhibitor monotherapy. The cost-effectiveness of nivolumab appears optimal, but the other PD-1/PD-L1 inhibitors are not as cost-effective for the first-line treatment of advanced NSCLC in China.
背景与目的：程序性死亡受体 1 及其配体（PD-1/PD-L1）抑制剂显著改变了非小细胞肺癌（NSCLC）的治疗前景。然而，由于尚未对其进行直接临床试验，其疗效和安全性尚不清楚。由于其成本高昂，因此还需要确定 PD-1/PD-L1 抑制剂的经济学。本研究旨在评估高 PD-L1 表达的 PD-1/PD-L1 抑制剂单药治疗作为一线治疗晚期 NSCLC 患者的疗效、安全性和成本效益。
方法：我们从 PubMed、Cochrane 和 Web of Science 数据库中检索了 PD-1/PD-L1 抑制剂单药治疗晚期 NSCLC 患者的生存、进展和安全性数据。我们进行了网络荟萃分析（NMA），以考虑 PD-1/PD-L1 抑制剂在疗效和安全性方面的情况。我们采用了具有全生命周期的 Markov 模型。我们通过试验收集了临床和效用数据。每质量调整生命年（QALY）的成本为增量成本效益比（ICER）。我们进行了敏感性分析。
结果：本研究纳入了五项使用四种药物（nivolumab、pembrolizumab、atezolizumab 和 durvalumab）的 III 期临床试验。NMA 表明，四种药物具有相似的疗效和安全性，而 pembrolizumab 和 atezolizumab 在无进展生存期（PFS）方面优于 nivolumab（风险比（HR）=0.66，95%置信区间（CI）：0.46-0.95 和 HR=0.59，95%CI：0.37-0.94），而 atezolizumab 发生严重不良事件的风险高于 nivolumab 和 pembrolizumab。与 nivolumab 相比，durvalumab、pembrolizumab 和 atezolizumab 的 QALY 分别为 0.19、0.38 和 0.53，导致的增量成本效益比（ICER）分别为 197028.8 美元/QALY、111859.0 美元/QALY 和 76182.3 美元/QALY。
结论：PD-1/PD-L1 抑制剂单药治疗的疗效和安全性相似。nivolumab 的成本效益似乎最佳，但其他 PD-1/PD-L1 抑制剂在中国作为晚期 NSCLC 的一线治疗并不具有成本效益。
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