帕博利珠单抗在PD-L1强阳性（TPS≥50%）非小细胞肺癌患者中根据转移部位的疗效差异
Differential Efficacy of Pembrolizumab According to Metastatic Sites in Patients With PD-L1 Strongly Positive (TPS ≥ 50%) NSCLC.
作者信息
Takeyasu Yuki, Yoshida Tatsuya, Shibaki Ryota, Matsumoto Yuji, Goto Yasushi, Kanda Shintaro, Horinouchi Hidehito, Yamamoto Noboru, Motoi Noriko, Ohe Yuichiro
机构信息
Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan; Course of Advanced Clinical Research of Cancer, Juntendo University Graduate School of Medicine, Tokyo, Japan.
Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.
出版信息
Clin Lung Cancer. 2021 Mar;22(2):127-133.e3. doi: 10.1016/j.cllc.2020.10.002. Epub 2020 Oct 16.
BACKGROUND
Pembrolizumab has shown significantly better efficacy than platinum doublet chemotherapy in patients with programmed cell death ligand 1 (PD-L1) strongly positive (tumor proportion score ≥ 50%) non-small-cell lung cancer (NSCLC). However, the predictors of response to pembrolizumab have not yet been fully elucidated for patients with PD-L1 strongly positive NSCLC.
PATIENTS AND METHODS
We retrospectively analyzed 145 patients who had been treated with pembrolizumab for PD-L1 strongly positive (TPS ≥ 50%) NSCLC without an EGFR (epidermal growth factor receptor) mutation or ALK rearrangement from February 2017 to March 2020. Various clinical characteristics, including Eastern Cooperative Oncology Group performance status, treatment line, PD-L1 expression, C-reactive protein level, neutrophil/lymphocyte ratio, and metastatic sites, and the clinical outcome of pembrolizumab treatment were examined.
RESULTS
Patients with higher PD-L1 expression (≥ 75%; n = 90) had a higher objective response rate (ORR) and longer progression-free survival (PFS) compared with those with lower expression (50%-74%; n = 55; ORR, 51% vs. 33%; P = .0305; median PFS, 13.9 months vs. 5.2 months; P = .0111). In addition, 15 patients with liver metastasis (LM) had a significantly lower ORR and shorter PFS than the 130 patients without LM (ORR, 20% vs. 47%; P = .0468; median PFS, 3.4 months vs. 9.4 months; P = .0018). A multivariate analysis indicated that PD-L1 expression and LM were significant predictors of PFS after pembrolizumab treatment (higher PD-L1 expression: hazard ratio, 0.58; 95% confidence interval, 0.38-0.91; P = .0183; presence of LM: hazard ratio, 2.05; 95% confidence interval, 1.03-3.82; P = .0420).
CONCLUSION
PD-L1 expression and LM status were predictors of the efficacy of pembrolizumab in patients with PD-L1 strongly positive NSCLC.
背景
在程序性细胞死亡配体1（PD-L1）强阳性（肿瘤比例评分≥50%）的非小细胞肺癌（NSCLC）患者中，帕博利珠单抗已显示出比铂类双联化疗显著更好的疗效。然而，对于PD-L1强阳性NSCLC患者，帕博利珠单抗反应的预测因素尚未完全阐明。
患者和方法
我们回顾性分析了2017年2月至2020年3月期间接受帕博利珠单抗治疗的145例PD-L1强阳性（TPS≥50%）、无表皮生长因子受体（EGFR）突变或间变性淋巴瘤激酶（ALK）重排的NSCLC患者。检查了各种临床特征，包括东部肿瘤协作组体能状态、治疗线数、PD-L1表达、C反应蛋白水平、中性粒细胞/淋巴细胞比值和转移部位，以及帕博利珠单抗治疗的临床结果。
结果
与PD-L1表达较低（50%-74%）的患者（n = 55）相比，PD-L1表达较高（≥75%；n = 90）的患者客观缓解率（ORR）更高，无进展生存期（PFS）更长（ORR，51%对33%；P = .0305；中位PFS，13.9个月对5.2个月；P = .0111）。此外，15例有肝转移（LM）的患者的ORR和PFS显著低于13例无LM的患者（ORR，20%对47%；P = .0468；中位PFS，3.4个月对9.4个月；P = .0018）。多变量分析表明，PD-L1表达和LM是帕博利珠单抗治疗后PFS的显著预测因素（PD-L1表达较高：风险比，0.58；95%置信区间，0.38-0.91；P = .0183；存在LM：风险比，2.05；95%置信区间，1.03-3.82；P = .0420）。
结论
PD-L1表达和LM状态是帕博利珠单抗治疗PD-L1强阳性NSCLC患者疗效的预测因素。
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