본문 바로가기
KERD
논문KCI 등재

PD-L1 Testing in Non-small Cell Lung Cancer: Past, Present, and Future

2

조회

0

다운로드

3

인용

0

참고문헌

키워드

주제분류병리학

초록

Blockade of the programmed cell death-1 (PD-1) axis has already been established as an effective treatment of non-small cell lung cancer. Immunohistochemistry (IHC) for programmed deathligand 1 (PD-L1) protein is the only available biomarker that can guide treatment with immune checkpoint inhibitors in non-small cell lung cancer. Because each PD-1/PD-L1 blockade was approved together with a specific PD-L1 IHC assay used in the clinical trials, pathologists have been challenged with performing various assays with a limited sample. To provide a more unified understanding of this, several cross-validation studies between platforms have been performed and showed consistent results. However, the interchangeability of assays may be limited in practice because of the risk of misclassification of patients for the treatment. Furthermore, several issues, including the temporal and spatial heterogeneity of PD-L1 expression in the tumor, and the potential for cytology specimens to be used as an alternative to tissue samples for PD-L1 testing, have still not been resolved. In the future, one of the main aims of immunotherapy research should be to find a novel predictive biomarker for PD-1 blockade therapy and a way to combine it with PDL1 IHC and other tests.

Abstract

Blockade of the programmed cell death-1 (PD-1) axis has already been established as an effective treatment of non-small cell lung cancer. Immunohistochemistry (IHC) for programmed deathligand 1 (PD-L1) protein is the only available biomarker that can guide treatment with immune checkpoint inhibitors in non-small cell lung cancer. Because each PD-1/PD-L1 blockade was approved together with a specific PD-L1 IHC assay used in the clinical trials, pathologists have been challenged with performing various assays with a limited sample. To provide a more unified understanding of this, several cross-validation studies between platforms have been performed and showed consistent results. However, the interchangeability of assays may be limited in practice because of the risk of misclassification of patients for the treatment. Furthermore, several issues, including the temporal and spatial heterogeneity of PD-L1 expression in the tumor, and the potential for cytology specimens to be used as an alternative to tissue samples for PD-L1 testing, have still not been resolved. In the future, one of the main aims of immunotherapy research should be to find a novel predictive biomarker for PD-1 blockade therapy and a way to combine it with PDL1 IHC and other tests.

참고문헌 (57)

  1. Borghaei H, "Nivolumab versus docetaxel in advanced nonsquamous non-small-cell lung cancer", N Engl J Med, 373, pp.1627~1639 (2015)
  2. Brahmer J, "Nivolumab versus docetaxel in advanced squamous-cell non-small-cell lung cancer", N Engl J Med, 373, pp.123~135 (2015)
  3. Reck M, "Pembrolizumab versus chemotherapy for PD-L1-positive non-small-cell lung cancer", N Engl J Med, 375, pp.1823~1833 (2016)
  4. Herbst RS, "Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer(KEYNOTE-010) : a randomised controlled trial", Lancet, 387, pp.1540~1550 (2016)
  5. Fehrenbacher L, "Atezolizumab versus docetaxel for patients with previously treated non-small-cell lung cancer(POPLAR) : a multicentre, open-label, phase 2 randomised controlled trial", Lancet, 387, pp.1837~1846 (2016)
  6. Rittmeyer A, "Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer(OAK) : a phase 3, open-label, multicentre randomised controlled trial", Lancet, 389, pp.255~265 (2017)
  7. Gulley JL, "Avelumab for patients with previously treated metastatic or recurrent non-small-cell lung cancer(JAVELIN Solid Tumor) : dose-expansion cohort of a multicentre, open-label, phase 1b trial", Lancet Oncol, 18, pp.599~610 (2017)
  8. Garassino MC, "Durvalumab as third-line or later treatment for advanced non-small-cell lung cancer(ATLANTIC) : an open-label, single-arm, phase 2 study", Lancet Oncol, 19, pp.521~536 (2018)
  9. "Non-small cell lung cancer. Version 3.2018" (2018)[URL]
  10. Dunn GP, "Cancer immunoediting : from immunosurveillance to tumor escape", Nat Immunol, 3, pp.991~998 (2002)
  11. Pardoll DM, "The blockade of immune checkpoints in cancer immunotherapy", Nat Rev Cancer, 12, pp.252~264 (2012)
  12. Schreiber RD, "Cancer immunoediting : integrating immunity's roles in cancer suppression and promotion", Science, 331, pp.1565~1570 (2011)
  13. Brahmer JR, "Safety and activity of anti-PD-L1 antibody in patients with advanced cancer", N Engl J Med, 366, pp.2455~2465 (2012)
  14. Hirsch FR, "PD-L1 Immunohistochemistry assays for lung cancer : results from phase 1 of the Blueprint PD-L1 IHC assay comparison project", J Thorac Oncol, 12, pp.208~222 (2017)
  15. Scheel AH, "Harmonized PD-L1 immunohistochemistry for pulmonary squamous-cell and adenocarcinomas", Mod Pathol, 29, pp.1165~1172 (2016)
  16. Rimm DL, "A prospective, multi-institutional, pathologist-based assessment of 4 immunohistochemistry assays for PD-L1 expression in non-small cell lung cancer", JAMA Oncol, 3, pp.1051~1058 (2017)
  17. Adam J, "Multicenter harmonization study for PD-L1 IHC testing in non-small-cell lung cancer", Ann Oncol, 29, pp.953~958 (2018)
  18. Ratcliffe MJ, "Agreement between programmed cell death ligand-1 diagnostic assays across multiple protein expression cutoffs in non-small cell lung cancer", Clin Cancer Res, 23, pp.3585~3591 (2017)
  19. Maher A. Sughayer, "Comparison of 22C3 PharmDx and SP263 Assays to Test PD-L1 Expression in NSCLC", Applied Immunohistochemistry & Molecular Morphology, 27(9), pp.663~666 (2019), Ovid Technologies (Wolters Kluwer Health)[DOI]
  20. Tsao MS, "PD-L1 immunohistochemistry comparability study in real-life clinical samples : results of Blueprint Phase 2 Project", J Thorac Oncol, 13, pp.1302~1311 (2018)
  21. Fujimoto D, "Predictive performance of four programmed cell death ligand 1 assay systems on nivolumab response in previously treated patients with non-small cell lung cancer", J Thorac Oncol, 13, pp.377~386 (2018)
  22. Marchetti A, "Multicenter comparison of 22C3 PharmDx(Agilent)and SP263(Ventana)assays to test PD-L1expression for NSCLC patients to be treated with immune checkpoint inhibitors", J Thorac Oncol, 12, pp.1654~1663 (2017)
  23. "VENTANA PD-L1 (SP263) Assay (CE IVD)" (2019)[URL]
  24. Munari E, "PD-L1 assays 22C3 and SP263are not interchangeable in non-small cell lung cancer when considering clinically relevant cutoffs : an interclone evaluation by differently trained pathologists", Am J Surg Pathol, 42, pp.1384~1389 (2018)
  25. Hendry S, "Comparison of four PD-L1immunohistochemical assays in lung cancer", J Thorac Oncol, 13, pp.367~376 (2018)
  26. Tsao MS, "IASLC atlas of PD-L1 immunohistochemistry testing in lung cancer" (2017), International Association for the Study of Lung Cancer
  27. Herbst RS, "Use of archival versus newly collected tumor samples for assessing PD-L1 expression and overall survival : an updated analysis of KEYNOTE-010 trial", Ann Oncol, 30, pp.281~289 (2019)
  28. Omori S, "Changes in programmed death ligand 1 expression in non-small cell lung cancer patients who received anticancer treatments", Int J Clin Oncol, 23, pp.1052~1059 (2018)
  29. Sheng J, "Expression of programmed death ligand-1 on tumor cells varies pre and post chemotherapy in nonsmall cell lung cancer", Sci Rep, 6, pp.20090~ (2016)
  30. 신정훈, "Effect of Platinum-Based Chemotherapy on PD-L1 Expression on Tumor Cells in Non-small Cell Lung Cancer", Cancer Research and Treatment, 51(3), pp.1086~1097 (2019), 대한암학회
  31. Azuma K, "Association of PD-L1 overexpression with activating EGFR mutations in surgically resected nonsmall-cell lung cancer", Ann Oncol, 25, pp.1935~1940 (2014)
  32. Han JJ, "Change in PD-L1 expression after acquiring resistance to gefitinib in EGFR-mutant non-small-cell lung cancer", Clin Lung Cancer, 17, pp.263.e2~270.e2 (2016)
  33. Ilie M, "Comparative study of the PDL1status between surgically resected specimens and matched biopsies of NSCLC patients reveal major discordances : a potential issue for anti-PD-L1 therapeutic strategies", Ann Oncol, 27, pp.147~153 (2016)
  34. Gniadek TJ, "Heterogeneous expression of PD-L1 in pulmonary squamous cell carcinoma and adenocarcinoma : implications for assessment by small biopsy", Mod Pathol, 30, pp.530~538 (2017)
  35. Kim H, "PD-L1 immunohistochemical assays for assessment of therapeutic strategies involving immune checkpoint inhibitors in non-small cell lung cancer : a comparative study", Oncotarget, 8, pp.98524~98532 (2017)
  36. Mansfield AS, "Heterogeneity of programmed cell death ligand 1 expression in multifocal lung cancer", Clin Cancer Res, 22, pp.2177~2182 (2016)
  37. Kim S, "Comparative analysis of PD-L1 expression between primary and metastatic pulmonary adenocarcinomas", Eur J Cancer, 75, pp.141~149 (2017)
  38. Niemeijer AN, "Whole body PD-1and PD-L1 positron emission tomography in patients with nonsmall-cell lung cancer", Nat Commun, 9, pp.4664~ (2018)
  39. Ilié M, "Detection of PD-L1 in circulating tumor cells and white blood cells from patients with advanced non-small-cell lung cancer", Ann Oncol, 29, pp.193~199 (2018)
  40. Guibert N, "PD-L1 expression in circulating tumor cells of advanced non-small cell lung cancer patients treated with nivolumab", Lung Cancer, 120, pp.108~112 (2018)
  41. Rebelatto MC, "Development of a programmed cell death ligand-1 immunohistochemical assay validated for analysis of non-small cell lung cancer and head and neck squamous cell carcinoma", Diagn Pathol, 11, pp.95~ (2016)
  42. Skov BG, "Paired comparison of PD-L1 expression on cytologic and histologic specimens from malignancies in the lung assessed with PD-L1 IHC 28-8pharmDx and PD-L1 IHC 22C3pharmDx", Appl Immunohistochem Mol Morphol, 25, pp.453~459 (2017)
  43. Heymann JJ, "PD-L1 expression in non-small cell lung carcinoma : comparison among cytology, small biopsy, and surgical resection specimens", Cancer Cytopathol, 125, pp.896~907 (2017)
  44. Wang H, "Cytology cell blocks are suitable for immunohistochemical testing for PD-L1 in lung cancer", Ann Oncol, 29, pp.1417~1422 (2018)
  45. Rizvi NA, "Cancer immunology : mutational landscape determines sensitivity to PD-1 blockade in non-small cell lung cancer", Science, 348, pp.124~128 (2015)
  46. Hellmann MD, "Nivolumab plus ipilimumab in lung cancer with a high tumor mutational burden", N Engl J Med, 378, pp.2093~2104 (2018)
  47. Mazzaschi G, "Low PD-1 expression in cytotoxic CD8(+)tumor-infiltrating lymphocytes confers an immuneprivileged tissue microenvironment in NSCLC with a prognostic and predictive value", Clin Cancer Res, 24, pp.407~419 (2018)
  48. Kim H, "Increased CD3+ T cells with a low FOXP3+", CD8+ T cell ratio can predict anti-PD-1 therapeutic response in non-small cell lung cancer patients, 2019, pp.32, 367~375
  49. Postow MA, "Peripheral T cell receptor diversity is associated with clinical outcomes following ipilimumab treatment in metastatic melanoma", J Immunother Cancer, 3, pp.23~ (2015)
  50. Weber JS, "A serum protein signature associated with outcome after anti-PD-1 therapy in metastatic melanoma", Cancer Immunol Res, 6, pp.79~86 (2018)
  51. Sivan A, "Commensal Bifidobacterium promotes antitumor immunity and facilitates anti-PD-L1 efficacy", Science, 350, pp.1084~1089 (2015)
  52. Snyder A, "Genetic basis for clinical response to CTLA-4 blockade in melanoma", N Engl J Med, 371, pp.2189~2199 (2014)
  53. Hellmann MD, "Tumor mutational burden and efficacy of nivolumab monotherapy and in combination with ipilimumab in small-cell lung cancer", Cancer Cell, 33, pp.853.e4~861.e4 (2018)
  54. Le DT, "PD-1 blockade in tumors with mismatch-repair deficiency", N Engl J Med, 372, pp.2509~2520 (2015)
  55. Carbone DP, "First-line nivolumab in stage IV or recurrent non-small-cell lung cancer", N Engl J Med, 376, pp.2415~2426 (2017)
  56. Rizvi H, "Molecular determinants of response to anti-programmed cell death(PD)-1 and anti-programmed death-ligand 1(PD-L1)blockade in patients with non-small-cell lung cancer profiled with targeted next-generation sequencing", J Clin Oncol, 36, pp.633~641 (2018)
  57. Deans ZC, "Integration of next-generation sequencing in clinical diagnostic molecular pathology laboratories for analysis of solid tumours; an expert opinion on behalf of IQN Path ASBL", Virchows Arch, 470, pp.5~20 (2017)

관련 논문AI추천

Temporal evolution of programmed death-ligand 1 expression in patients with non-small cell lung cancer김범석, 김태민, Chang Hyun Nam, Chan-Young Ock, Dae Seog Heo, Dong-Wan Kim, Doo Hyun Chung, Jaemoon Koh, Miso Kim, Yoon Kyung Jeon대한내과학회 · The Korean Journal of Internal Medicine2021 · 제36권 제4호Immunotherapy for Non-small Cell Lung Cancer: Current Landscape and Future Perspectives김혜련, 임선민, Min Hee Hong대한면역학회 · Immune Network2020 · 제20권 제1호Interobserver Reproducibility of PD-L1 Biomarker in Non-small Cell Lung Cancer: A Multi-Institutional Study by 27 Pathologists박형규, 장선희, 장세진, 최윤라, Cardiopulmonary Pathology Study Group of the Korean Society of Patholo대한병리학회 · Journal of Pathology and Translational Medicine2019 · 제53권 제6호Effect of Platinum-Based Chemotherapy on PD-L1 Expression on Tumor Cells in Non-small Cell Lung Cancer김세현, 김유정, 김지원, 김지현, 김진원, 방수미, 서경진, 신정훈, 이규상, 이근욱, 이정옥, 이종석, 이지윤, 정진행대한암학회 · Cancer Research and Treatment2019 · 제51권 제3호Exploring histological predictive biomarkers for immune checkpoint inhibitor therapy response in non–small cell lung cancer박형순, 임소영, 조의주대한병리학회 · Journal of Pathology and Translational Medicine2024 · 제58권 제2호Programmed cell death-ligand 1 assessment in urothelial carcinoma: prospect and limitation이규상, 최기영대한병리학회 · Journal of Pathology and Translational Medicine2021 · 제55권 제3호

이 간행물의 다른 논문 (10건)