The International Association for the Study of Lung Cancer Global Survey on Programmed Death-Ligand 1 Testing for NSCLC.
The International Association for the Study of Lung Cancer Global Survey on Programmed Death-Ligand 1 Testing for NSCLC.
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DOI：
10.1016/j.jtho.2020.12.026
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发表时间：
2021-04
影响因子：
20.4
通讯作者：
Lantuejoul, Sylvie
中科院分区：
文献类型：
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作者：
Mino-Kenudson, Mari;Le Stang, Nolwenn;Daigneault, Jillian B.;Nicholson, Andrew G.;Cooper, Wendy A.;Roden, Anja C.;Moreira, Andre L.;Thunnissen, Erik;Papotti, Mauro;Pelosi, Giuseppe;Motoi, Noriko;Poleri, Claudia;Brambilla, Elisabeth;Redman, Mary;Jain, Deepali;Dacic, Sanja;Yatabe, Yasushi;Tsao, Ming Sound;Lopez-Rios, Fernando;Botling, Johan;Chen, Gang;Chou, Teh-Ying;Hirsch, Fred R.;Beasley, Mary Beth;Borczuk, Alain;Bubendorf, Lukas;Chung, Jin-Haeng;Hwang, David;Lin, Dongmei;Longshore, John;Noguchi, Masayuki;Rekhtman, Natasha;Sholl, Lynette;Travis, William;Yoshida, Akihiko;Wynes, Murry W.;Wistuba, Ignacio I.;Kerr, Keith M.;Lantuejoul, Sylvie
需要进行PD-L1免疫组化（IHC），以确定帕博利珠单抗单药治疗全球晚期非小细胞肺癌（NSCLC）和其他几种适应症（取决于国家）的合格性。四种检测试剂盒已获得批准/CE-IVD认证，但PD-L1 IHC在各地区和实验室间的实施似乎存在困难，需要应用实验室开发的检测试剂盒（LDT）。为了评估PD-L1 IHC的实践并确定问题和差异，IASLC病理委员会于2019年1月至5月对病理学家进行了一项全球调查，包括关于分析前，分析和分析后条件的多个问题。来自64个国家的344名病理学家参与了研究，其中41%来自欧洲，24%来自北美，18%来自亚洲。除了活检和切除，75%的参与者使用细胞块，11%使用涂片。克隆22 C3最常用（69%），其次是SP263（51%）。分别有40%和30%的用户将其作为LDT，76%的参与者至少开发了一个LDT。一半的参与者报告周转时间（达特）≤ 2天，而13%的参与者报告≥ 5天。此外，分别有18%、16%和14%的参与者没有实施质量保证（QA）、评分和标准化报告的正式培训。PD-L1检测中的异质性在抗体克隆、IHC检测、样本、TAT和QA措施方面在不同地区和实验室之间存在差异。相当多的少数人指出，缺乏质量保证、正规培训和标准化报告，这表明需要采取更多的质量保证措施和提供更多的培训机会。
PD-L1 immunohistochemistry (IHC) is required to determine eligibility for pembrolizumab monotherapy in advanced non-small cell lung cancer (NSCLC) worldwide and for several other indications depending on the country. Four assays have been approved/CE-IVD marked, but PD-L1 IHC seems diversely implemented across regions and laboratories with the application of laboratory-developed tests (LDTs). To assess practice of PD-L1 IHC and identify issues and disparities, the IASLC pathology committee conducted a global survey for pathologists from January to May 2019, comprising multiple questions on pre-analytical, analytical and post-analytical conditions. 344 pathologists from 64 countries participated with 41% from Europe, 24% from North America, and 18% from Asia. Besides biopsies and resections, cellblocks were used by 75% of the participants and smears by 11%. The clone 22C3 was most commonly used (69%) followed by SP263 (51%). They were applied as a LDT by 40% and 30% of the users, respectively, and 76% of the participants developed at least one LDT. A half of the participants reported turnaround time (TAT) of ≤ 2 days, while 13% reported that of ≥ 5 days. Additionally, quality assurance (QA), formal training for scoring and standardized reporting were not implemented by 18%, 16% and 14% of the participants, respectively. Heterogeneity in PD-L1 testing is marked across regions and laboratories in terms of antibody clones, IHC assays, samples, TATs and QA measures. The lack of QA, formal training and standardized reporting stated by a significant minority identifies a need for additional QA measures and training opportunities.
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DOI：
10.1097/pai.0000000000000572
发表时间：
2019-02-01
影响因子：
1.6
作者：
Lloyd, Isaac E.;Zhou, Wenhua;Chadwick, Barbara E.
通讯作者：
Chadwick, Barbara E.
DOI：
10.1038/s41379-019-0372-z
发表时间：
2020-04
期刊：
Modern pathology : an official journal of the United States and Canadian Academy of Pathology, Inc
影响因子：
--
作者：
Lawson NL;Dix CI;Scorer PW;Stubbs CJ;Wong E;Hutchinson L;McCall EJ;Schimpl M;DeVries E;Walker J;Williams GH;Hunt J;Barker C
通讯作者：
Barker C
DOI：
10.1097/pai.0000000000000256
发表时间：
2015-09
期刊：
Applied immunohistochemistry & molecular morphology : AIMM
影响因子：
--
作者：
Phillips T;Simmons P;Inzunza HD;Cogswell J;Novotny J Jr;Taylor C;Zhang X
通讯作者：
Zhang X
影响因子：
158.5
作者：
Garon, Edward B.;Rizvi, Naiyer A.;Gandhi, Leena
通讯作者：
Gandhi, Leena
影响因子：
20.4
作者：
Fujimoto, Daichi;Sato, Yuki;Tomii, Keisuke
通讯作者：
Tomii, Keisuke