1. Comparison of SP263 and 22C3 pharmDx assays to test programmed death ligand‐1 (PD‐L1) expression in surgically resected non‐small cell lung cancer
- Author
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Naoko Shigeta, Shuji Murakami, Tomoyuki Yokose, Tetsuya Isaka, Kanako Shinada, Takuya Nagashima, Hiroyuki Adachi, Shunsuke Shigefuku, Kotaro Murakami, Jun Miura, Noritake Kikunishi, Kozue Watabe, Haruhiro Saito, and Hiroyuki Ito
- Subjects
immune checkpoint inhibitors (ICIs) ,non‐small cell lung cancer (NSCLC) ,PD‐L1 immunohistochemistry assay ,programmed death ligand‐1 ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
Abstract Background Atezolizumab, one of the immune checkpoint inhibitors, has been approved as an adjuvant treatment following resection and platinum‐based chemotherapy in patients with stage II–IIIA non‐small cell lung cancer with 1% or more programmed death ligand‐1 (PD‐L1) expression. The Food and Drug Administration (FDA) has approved SP263 as a companion diagnostic assay for adjuvant treatment with atezolizumab; however, in clinical practice, the 22C3 assay is most commonly used for advanced non‐small cell lung cancer. Therefore, our study aimed to compare two PD‐L1 assays, SP263 and 22C3, to evaluate whether 22C3 could replace SP263 when deciding whether to administer adjuvant atezolizumab. Methods We retrospectively and prospectively analyzed 98 patients who underwent surgical resection at Kanagawa Cancer Center (Japan). An immunohistochemistry assay was performed for all the cases with both SP263 and 22C3. We statistically analyzed the concordance of PD‐L1 expression between SP263 and 22C3 assays. Results The concordance between the two assays using Cohen's kappa was κ = 0.670 (95% CI: 0.522–0.818) at the 1% cutoff and κ = 0.796 (95% CI: 0.639–0.954) at the 50% cutoff. The Spearman correlation coefficient of 0.874 (p
- Published
- 2024
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