Kim Sue Youn, Kim Tae-Eun, Park Chan Kwon, Yoon Hyoung-Kyu, Sa Young Jo, Kim Hyo Rim, Woo In Sook, Kim Tae-Jung
Department of Hospital Pathology, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul 06591, Korea.
Department of Hospital Pathology, Yeouido St. Mary's Hospital, College of Medicine, The Catholic University of Korea, 10, 63-ro, Yeongdeungpo-gu, Seoul 07345, Korea.
Cancers (Basel). 2022 Jun 27;14(13):3138. doi: 10.3390/cancers14133138.
PD-L1 harmonization studies revealed a strong correlation between the 22C3 and SP263 assays in non-small-cell lung cancer (NSCLC). However, the assays’ characteristics have yet to be validated in a variety of clinical and analytical settings. The results of 431 NSCLC samples tested concurrently in routine clinical practice with the PD-L1 22C3 and SP263 assays were reviewed, and both assays were performed on 314 archives of surgically resected NSCLCs to assess PD-L1 expression in relation to variables such as FFPE block age and FFPE section storage condition. In routine clinical samples, 22C3 showed the highest concordance rate with 94.5% of SP263 tumor proportion score (TPS) ≥50% and 92.3% of SP263 TPS ≥1%, while SP263 showed a concordance rate with 79.6% of 22C3 TPS ≥50% and 89.9% of 22C3 TPS ≥1%. In the archival analysis, the high TPS of 22C3 and SP263 (versus TPS 1%) were significantly associated with a more recent block (<3 years versus ≥3 years) (p = 0.007 and p = 0.009, respectively). Only the TPS of 22C3 was reduced when FFPE sections were stored at room temperature compared to SP263. However, when stored at 4 °C, the storage duration had no effect on expression in either assay. For 22C3 TPS 1−49 percent and ≥50 percent (OR = 1.73, p = 0.006 and OR = 1.98, p = 0.002, respectively). There was a considerably larger chance of preserved 22C3 expression in recent room-temperature paraffin section storage, although SP263 demonstrated preserved expression in prolonged room-temperature section storage. Despite the good association between PD-L1 22C3 and SP263 in routine clinical samples, FFPE blocks older than 3 years and sections held at room temperature for more than 1 week may result in an underestimation of PD-L1 status, particularly for the 22C3 test. However, the SP263 assay was more sensitive under these conditions.
PD-L1一致性研究显示，在非小细胞肺癌（NSCLC）中，22C3检测法与SP263检测法之间存在强相关性。然而，这些检测法的特性尚未在各种临床和分析环境中得到验证。回顾了在常规临床实践中同时使用PD-L1 22C3和SP263检测法检测的431例NSCLC样本的结果，并对314例手术切除的NSCLC存档样本进行了这两种检测，以评估PD-L1表达与诸如FFPE组织块保存年限和FFPE切片保存条件等变量的关系。在常规临床样本中，22C3与SP263肿瘤比例评分（TPS）≥50%的一致性率最高，为94.5%，与SP263 TPS≥1%的一致性率为92.3%，而SP263与22C3 TPS≥50%的一致性率为79.6%，与22C3 TPS≥1%的一致性率为89.9%。在存档分析中，22C3和SP263的高TPS（相对于TPS 1%）与更新的组织块（<3年对比≥3年）显著相关（分别为p = 0.007和p = 0.009）。与SP263相比，当FFPE切片在室温下保存时，只有22C3的TPS降低。然而，当在4℃保存时，保存时长对两种检测法的表达均无影响。对于22C3 TPS为1%-49%和≥50%的情况（OR分别为 = 1.73，p = 0.006和OR = 1.98，p = 0.002）。在近期室温石蜡切片保存中，22C3表达保留的可能性要大得多，尽管SP263在长时间室温切片保存中显示出表达保留。尽管在常规临床样本中PD-L1 22C3与SP263之间具有良好的相关性，但保存年限超过3年的FFPE组织块以及在室温下保存超过1周的切片可能会导致PD-L1状态被低估，尤其是对于22C3检测。然而，在这些条件下，SP263检测法更敏感。
