ALK 融合的晚期 NSCLC 患者中 PD-L1 表达与阿来替尼疗效的相关性。
Association of PD-L1 expression with efficacy of alectinib in advanced NSCLC patients with ALK fusion.
机构信息
Department of Medical Oncology, Shanghai Pulmonary Hospital, Cancer Institute, Tongji University School of Medicine, Shanghai 200433, PR China.
Department of Pathology, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai 200433, PR China.
出版信息
Lung Cancer. 2023 Jul;181:107233. doi: 10.1016/j.lungcan.2023.107233. Epub 2023 May 10.
BACKGROUND
Programmed cell death-ligand 1 (PD-L1) expression was found to be a biomarker of inferior efficacy of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) in EGFR-mutated non-small cell lung cancer (NSCLC). However, whether PD-L1 expression could also serve as a similar biomarker in anaplastic lymphoma kinase (ALK)-positive patients, especially for those treated with front-line alectinib, remains unclear. The aim of the study is to investigate the association of PD-L1 expression and efficacy of alectinib in this setting.
METHODS
From January 2018 to March 2020, 225 patients with ALK-rearranged lung cancer were consecutively collected at Shanghai Pulmonary Hospital, Tongji University. Baseline PD-L1 expression was detected using immunohistochemistry (IHC) in 56 patients of advanced ALK-rearranged lung cancer who received front-line alectinib.
RESULTS
Among the 56 eligible patients, 30 (53.6%) were PD-L1 expression negative, 19 (33.9%) patients had TPS 1%-49% and 7 (12.5%) had TPS ≥ 50%.We found no statistically significant associations between PD-L1 positivity and objective response rate (ORR, 90.0% vs. 80.8%, p = 0.274) or progression-free survival (PFS, not reached vs. not reached, HR: 0.98, 95 %CI: 0.37-2.61, p = 0.97) in patients treated with alectinib. Meanwhile, patients with PD-L1 high expression (TPS ≥ 50%) had a trend of longer PFS (not reached vs. not reached, p = 0.61).
CONCLUSIONS
PD-L1 expression might not serve as a predict biomarker for the efficacy of front-line alectinib in ALK-positive NSCLC patients.
背景
程序性死亡配体 1（PD-L1）表达被发现是表皮生长因子受体（EGFR）酪氨酸激酶抑制剂（TKIs）在 EGFR 突变型非小细胞肺癌（NSCLC）中疗效不佳的生物标志物。然而，PD-L1 表达是否也可以作为间变性淋巴瘤激酶（ALK）阳性患者的类似生物标志物，特别是对于那些接受一线阿来替尼治疗的患者，目前尚不清楚。本研究旨在探讨 PD-L1 表达与阿来替尼在这一人群中的疗效的关系。
方法
2018 年 1 月至 2020 年 3 月，同济大学附属上海市肺科医院连续收集了 225 例 ALK 重排肺癌患者。对 56 例接受一线阿来替尼治疗的晚期 ALK 重排肺癌患者进行了 PD-L1 表达的免疫组织化学（IHC）检测。
结果
在 56 例合格患者中，30 例（53.6%）为 PD-L1 表达阴性，19 例（33.9%）患者 PD-L1 肿瘤比例评分（TPS）为 1%-49%，7 例（12.5%）患者 TPS≥50%。我们发现 PD-L1 阳性与客观缓解率（ORR，90.0%与 80.8%，p=0.274）或无进展生存期（PFS，未达到与未达到，HR：0.98，95%CI：0.37-2.61，p=0.97）之间无统计学显著相关性在接受阿来替尼治疗的患者中。同时，PD-L1 高表达（TPS≥50%）患者的 PFS 有延长趋势（未达到与未达到，p=0.61）。
结论
PD-L1 表达可能不能作为 ALK 阳性 NSCLC 患者一线阿来替尼疗效的预测生物标志物。
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