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纳武利尤单抗对比帕博利珠单抗治疗经治晚期非小细胞肺癌患者的真实世界研究:倾向性评分匹配分析。

Nivolumab versus pembrolizumab in previously-treated advanced non-small cell lung cancer patients: A propensity-matched real-world analysis.

机构信息

Department of Thoracic Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan; Department of Respiratory Medicine, Juntendo University Graduate School of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo 113-8431, Japan.

Department of Thoracic Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan; Department of Experimental Therapeutics, National Cancer Center Hospital, 5-1-1, Tsukiji, Chuo-ku, Tokyo 104-0045, Japan.

出版信息

Lung Cancer. 2022 May;167:49-57. doi: 10.1016/j.lungcan.2022.03.020. Epub 2022 Apr 4.

Abstract

OBJECTIVE

Nivolumab and pembrolizumab have been the standard of care in patients with previously treated advanced non-small cell lung cancer (NSCLC). This study aimed to compare the efficacy and safety of nivolumab and pembrolizumab.

MATERIALS AND METHODS

We retrospectively reviewed data of advanced NSCLC patients with PD-L1 (Programmed death-ligand 1) [clone:22C3] positive tumors (Tumor proportion score [TPS] ≥ 1%) who had been treated with nivolumab or pembrolizumab as second- or subsequent line from 2015 to 2021.Propensity score matching was performed to reduce potential selection bias. We analyzed the clinical outcomes including objective response rate (ORR), progression-free survival (PFS), overall survival (OS), and immune-related adverse events (irAEs).

RESULTS

Among a total of 202 eligible patients, 72 pairs of patients from each group were identified after propensity score matching. There were no significant differences in ORR, PFS, and OS between the two agents (nivolumab vs. pembrolizumab: ORR, 23.6% vs. 20.8%, median PFS, 3.7 months vs. 4.6 months, hazard ratio [HR] 1.02; 95% confidence interval [CI], 0.71 to 1.46; p = 0.92, and median OS, 27.4 months vs. 19.6 months, HR 0.78; 95% CI, 0.51 to 1.20; p = 0.24). Additionally, PFS was similar between the treatments in the PD-L1 TPS ≥ 50% subgroup (median PFS, 3.7 months vs. 4.6 months, HR 0.94; 95% CI, 0.56 to 1.59; p = 0.82) and PD-L1 TPS 1-49% subgroup (median PFS, 3.7 months vs.4.6 months, HR 1.13; 95% CI, 0.69 to 1.85; p = 0.61). There was also no significant difference in the frequency of grade ≥ 3 irAEs (9.7% vs. 11.1%; p = 1.0).

CONCLUSION

There is no significant difference in the efficacy and safety between nivolumab and pembrolizumab in advanced NSCLC patients with PD-L1-positive tumors in the subsequent line setting.

摘要

目的

纳武利尤单抗和帕博利珠单抗已成为治疗先前接受过治疗的晚期非小细胞肺癌(NSCLC)患者的标准治疗方法。本研究旨在比较纳武利尤单抗和帕博利珠单抗的疗效和安全性。

材料和方法

我们回顾性分析了 2015 年至 2021 年期间,PD-L1(程序性死亡配体 1)[克隆:22C3]阳性肿瘤(肿瘤比例评分[TPS]≥1%)的晚期 NSCLC 患者接受纳武利尤单抗或帕博利珠单抗二线或后续治疗的临床数据。采用倾向评分匹配法以减少潜在的选择偏倚。我们分析了包括客观缓解率(ORR)、无进展生存期(PFS)、总生存期(OS)和免疫相关不良事件(irAE)在内的临床结局。

结果

在总共 202 例符合条件的患者中,每组各有 72 对患者在倾向评分匹配后被确定。两种药物之间的 ORR、PFS 和 OS 无显著差异(纳武利尤单抗组与帕博利珠单抗组:ORR,23.6%比 20.8%,中位 PFS,3.7 个月比 4.6 个月,风险比[HR]1.02;95%置信区间[CI]0.71 至 1.46;p=0.92,中位 OS,27.4 个月比 19.6 个月,HR 0.78;95%CI0.51 至 1.20;p=0.24)。此外,在 PD-L1 TPS≥50%亚组(中位 PFS,3.7 个月比 4.6 个月,HR 0.94;95%CI0.56 至 1.59;p=0.82)和 PD-L1 TPS 1-49%亚组(中位 PFS,3.7 个月比 4.6 个月,HR 1.13;95%CI0.69 至 1.85;p=0.61)中,两种治疗方法的 PFS 也无显著差异。≥3 级 irAE 的发生频率也无显著差异(9.7%比 11.1%;p=1.0)。

结论

在 PD-L1 阳性肿瘤的晚期 NSCLC 患者二线治疗中,纳武利尤单抗和帕博利珠单抗在疗效和安全性方面无显著差异。

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