Real-world PD-L1 testing and distribution of PD-L1 tumor expression by immunohistochemistry assay type among patients with metastatic non-small cell lung cancer in the United States.
Real-world PD-L1 testing and distribution of PD-L1 tumor expression by immunohistochemistry assay type among patients with metastatic non-small cell lung cancer in the United States.
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DOI：
10.1371/journal.pone.0206370
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发表时间：
2018
期刊：
影响因子：
3.7
通讯作者：
Burke T
中科院分区：
文献类型：
--
作者：
Velcheti V;Patwardhan PD;Liu FX;Chen X;Cao X;Burke T
抗程序性死亡受体1（抗PD-1）派姆单抗获批作为PD-配体1（PD-L1）肿瘤表达≥ 50%的转移性非小细胞肺癌（mNSCLC）的一线单药治疗。通过免疫组织化学（IHC）检测类型比较PD-L1结果的大多数研究均由预先指定的、在大多数情况下经验丰富的、经过培训的病理学家进行;然而，关于PD-L1检测在现实世界临床环境中的当前使用和一致性的知识有限。我们的目的是研究美国肿瘤学实践中mNSCLC患者中通过IHC检测类型确定的PD-L1肿瘤表达的分布。这项回顾性观察性研究使用了来自美国大型电子病历数据库的去识别纵向数据。合格患者为2015年10月至2017年12月期间经组织学/细胞学证实的转移性或复发性NSCLC初始诊断的成人（≥18岁）。我们通过IHC检测类型确定了PD-L1检测趋势和PD-L1肿瘤表达分布（PD-L1染色肿瘤细胞百分比）。12，574名合格患者（平均年龄69岁）包括6，620名（53%）男性，86%有吸烟史。在4，868项可评价检测中，分别有3，799项（78%）、195项（4%）、165项（3%）和709项（15%）使用了Agilent 22 C3 pharmDx、Agilent 28-8 pharmDx、Ventana PD-L1（SP142）检测试剂盒和实验室开发的检测试剂盒（LDT，包括SP263）。PD-L1肿瘤表达评分≥50%的检测百分比分别为33%、32%、10%和23%。测量的PD-L1肿瘤表达在四种测定类型（χ2 p < 0.001）和三种测定类型（不包括SP142）之间存在差异（p < 0.001），22 C3和28-8测定之间无显著差异（p = 0.96）。PD-L1检测率从2015年第四季度的18%上升到2017年第四季度的71%。在现实世界的临床环境中，我们观察到使用22 C3和28-8测定法测量的PD-L1肿瘤表达是一致的;然而，SP142测定法和LDT似乎不一致，并且可能低估高PD-L1阳性。需要进一步研究来评估PD-L1肿瘤表达与治疗反应之间的关联。
The anti-programmed death receptor-1 (anti–PD-1) pembrolizumab is approved as first-line monotherapy for metastatic non-small cell lung cancer (mNSCLC) with PD-ligand 1 (PD-L1) tumor expression ≥50%. Most studies comparing PD-L1 results by immunohistochemistry (IHC) assay type have been conducted by prespecified and, in most cases, highly experienced, trained pathologists; however, knowledge is limited regarding the current use and concordance of PD-L1 assays in the real-world clinical setting. Our aim was to study the distribution of PD-L1 tumor expression by IHC assay type among patients with mNSCLC in US oncology practices. This retrospective observational study utilized de-identified, longitudinal data from a large US electronic medical record database. Eligible patients were adults (≥18 years) with histologically/cytologically confirmed initial diagnosis of metastatic or recurrent NSCLC from October 2015 through December 2017. We determined PD-L1 testing trends and distribution of PD-L1 tumor expression (percentage of tumor cells staining for PD-L1) by IHC assay type. The 12,574 eligible patients (mean age, 69 years) included 6,620 (53%) men and 86% with positive smoking history. Of 4,868 evaluable tests, 3,799 (78%), 195 (4%), 165 (3%), and 709 (15%) used the Agilent 22C3 pharmDx, Agilent 28–8 pharmDx, Ventana PD-L1 (SP142) Assay, and laboratory-developed tests (LDTs, including SP263), respectively. The percentages of tests scoring PD-L1 tumor expression of ≥50% were 33%, 32%, 10%, and 23%, respectively. Measured PD-L1 tumor expression varied across the four assay types (χ2 p < 0.001) and across three assay types excluding SP142 (p < 0.001), with no significant difference between 22C3 and 28–8 assays (p = 0.96). The PD-L1 testing rate increased from 18% in the fourth quarter of 2015 to 71% in the fourth quarter of 2017. In the real-world clinical setting, we observed that measured PD-L1 tumor expression is concordant using the 22C3 and 28–8 assays; however, the SP142 assay and LDTs appear discordant and could underestimate high PD-L1 positivity. Further study is needed to evaluate the association between PD-L1 tumor expression and response to therapy.
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影响因子：
28.4
作者：
Rimm DL;Han G;Taube JM;Yi ES;Bridge JA;Flieder DB;Homer R;West WW;Wu H;Roden AC;Fujimoto J;Yu H;Anders R;Kowalewski A;Rivard C;Rehman J;Batenchuk C;Burns V;Hirsch FR;Wistuba II
通讯作者：
Wistuba II
影响因子：
168.9
作者：
Hiley, Crispin T.;Le Quesne, John;Swanton, Charles
通讯作者：
Swanton, Charles
影响因子：
20.4
作者：
Hirsch, Fred R.;McElhinny, Abigail;Kerr, Keith M.
通讯作者：
Kerr, Keith M.
DOI：
10.1634/theoncologist.2017-0078
发表时间：
2017-11
期刊：
The oncologist
影响因子：
--
作者：
Pai-Scherf L;Blumenthal GM;Li H;Subramaniam S;Mishra-Kalyani PS;He K;Zhao H;Yu J;Paciga M;Goldberg KB;McKee AE;Keegan P;Pazdur R
通讯作者：
Pazdur R
影响因子：
20.4
作者：
Hendry, Shona;Byrne, David J.;Fox, Stephen B.
通讯作者：
Fox, Stephen B.