Department of Cellular Pathology, Royal Liverpool University Hospital, Duncan Building, Prescot Street, Liverpool L8 7XP, United Kingdom.
Precision Medicine, Oncology R&D, AstraZeneca, Cambridge SG8 6HB, UK.
Lung Cancer. 2020 Mar;141:101-106. doi: 10.1016/j.lungcan.2020.01.010. Epub 2020 Jan 13.
Evaluation of tumoral programmed cell death ligand-1 (PD-L1) expression is standard practice for patients with advanced non-small-cell lung cancer (NSCLC) who may be candidates for treatment targeting the programmed cell death-1 (PD-1)/PD-L1 pathway. Currently, all of the commercially available immunohistochemistry assays have been validated for use with histology specimens although, in routine clinical practice, approximately 30-40 % of patients with advanced NSCLC have only cytology specimens available for diagnosis, staging, and biomarker analysis. This systematic review evaluated the success rate, concordance, and clinical utility of using cytology specimens to assess tumor PD-L1 expression levels compared with histology specimens from patients with advanced NSCLC. EMBASE and PubMed database searches identified 142 unique, relevant publications, of which 15 met the inclusion criteria for at least one analysis. In 709 specimens, across seven publications, the proportion of cytology specimens evaluable for PD-L1 testing was 92.0 %. Among nine studies eligible for concordance analysis between cytology and histology specimens at a PD-L1 tumor cell expression cutoff of ≥50 %, overall percentage agreement was 89.7 % (n = 428), 72.0 % for positive percentage agreement (n = 218), and 95.0 % for negative percentage agreement (n = 258); results using a tumor PD-L1 expression cutoff of ≥1 % were similar. Our analyses suggest that using cytology specimens to assess PD-L1 expression is feasible, with good levels of concordance between cytology and histology specimens using PD-L1 tumor cell expression cutoffs of ≥1 % and ≥50 %. In conclusion, there is no convincing evidence that cytology specimens are inadequate or inferior to histology specimens for assessing PD-L1 expression in patients with NSCLC.
评估肿瘤程序性细胞死亡配体-1（PD-L1）表达是晚期非小细胞肺癌（NSCLC）患者的标准治疗方法，这些患者可能是针对程序性细胞死亡-1（PD-1）/PD-L1 通路的治疗靶点。目前，所有商业上可用的免疫组织化学检测方法都已在组织学标本上得到验证，尽管在常规临床实践中，大约 30-40%的晚期 NSCLC 患者仅有细胞学标本可用于诊断、分期和生物标志物分析。本系统评价评估了使用细胞学标本评估晚期 NSCLC 患者肿瘤 PD-L1 表达水平与组织学标本相比的成功率、一致性和临床实用性。EMBASE 和 PubMed 数据库搜索确定了 142 篇独特的相关文献，其中 15 篇文献至少符合一项分析的纳入标准。在 709 份标本中，来自 7 项研究，可评估 PD-L1 检测的细胞学标本比例为 92.0%。在 9 项研究中，有 428 份细胞学和组织学标本的 PD-L1 肿瘤细胞表达截断值≥50%的一致性分析符合纳入标准，总体百分比一致性为 89.7%（n=428），阳性百分比一致性为 72.0%（n=218），阴性百分比一致性为 95.0%（n=258）；使用肿瘤 PD-L1 表达截断值≥1%的结果相似。我们的分析表明，使用细胞学标本评估 PD-L1 表达是可行的，使用 PD-L1 肿瘤细胞表达截断值≥1%和≥50%时，细胞学和组织学标本之间具有良好的一致性。总之，没有令人信服的证据表明细胞学标本在评估 NSCLC 患者 PD-L1 表达方面不足或不如组织学标本。
