Agilent Technologies (2021) PD-L1 IHC 22C3 pharmDx instructions for use. https://www.agilent.com/cs/library/packageinsert/public/P03951E_20.pdf . Accessed 27 Mar 2024

Agilent Technologies (2021) PD-L1 IHC 28–8 pharmDx instructions for use. https://www.agilent.com/cs/library/packageinsert/public/PD04163_rev_02_SK00521-5_IFU.pdf . Accessed 27 Mar 2024

Ahn S, Kim K-M (2021) PD-L1 expression in gastric cancer: interchangeability of 22C3 and 28–8 pharmDx assays for responses to immunotherapy. Mod Pathol 34:1719–1727. https://doi.org/10.1038/s41379-021-00823-9

Article  CAS  PubMed  Google Scholar 

Bajorin DF, Witjes JA, Gschwend J, Schenker M, Valderrama BP, Tomita Y, Bamias A, Lebret T, Shariat S, Park SH, Ye D, Agerbaek M, Collette S, Unsal-Kacmaz K, Zardavas D, Koon HB, Galsky MD (2021) First results from the phase 3 CheckMate 274 trial of adjuvant nivolumab vs placebo in patients who underwent radical surgery for high-risk muscle-invasive urothelial carcinoma (MIUC). J Clin Oncol 39:Abstract 391. https://doi.org/10.1200/JCO.2021.39.6_suppl.391

Article  Google Scholar 

Bajorin DF, Witjes JA, Gschwend JE, Schenker M, Valderrama BP, Tomita Y, Bamias A, Lebret T, Shariat SF, Park SH, Ye D, Agerbaek M, Enting D, McDermott R, Gajate P, Peer A, Milowsky MI, Nosov A, Neif Antonio J, Tupikowski K, Toms L, Fischer BS, Qureshi A, Collette S, Unsal-Kacmaz K, Broughton E, Zardavas D, Koon HB, Galsky MD (2021) Adjuvant nivolumab versus placebo in muscle-invasive urothelial carcinoma. N Engl J Med 384:2102–2114. https://doi.org/10.1056/NEJMoa2034442

Article  CAS  PubMed  PubMed Central  Google Scholar 

Balar AV, Galsky MD, Rosenberg JE, Powles T, Petrylak DP, Bellmunt J, Loriot Y, Necchi A, Hoffman-Censits J, Perez-Gracia JL, Dawson NA, van der Heijden MS, Dreicer R, Srinivas S, Retz MM, Joseph RW, Drakaki A, Vaishampayan UN, Sridhar SS, Quinn DI, Durán I, Shaffer DR, Eigl BJ, Grivas PD, Yu EY, Li S, Kadel EE, Boyd Z, Bourgon R, Hegde PS, Mariathasan S, Thåström A, Abidoye OO, Fine GD, Bajorin DF (2017) Atezolizumab as first-line treatment in cisplatin-ineligible patients with locally advanced and metastatic urothelial carcinoma: a single-arm, multicentre, phase 2 trial. Lancet 389:67–76. https://doi.org/10.1016/s0140-6736(16)32455-2

Article  CAS  PubMed  Google Scholar 

Baxi V, Lee G, Duan C, Pandya D, Cohen DN, Edwards R, Chang H, Li J, Elliott H, Pokkalla H, Glass B, Agrawal N, Lahiri A, Wang D, Khosla A, Wapinski I, Beck A, Montalto M (2022) Association of artificial intelligence-powered and manual quantification of programmed death-ligand 1 (PD-L1) expression with outcomes in patients treated with nivolumab & #xb1; ipilimumab. Mod Pathol 35:1529–1539. https://doi.org/10.1038/s41379-022-01119-2

Article  CAS  PubMed  PubMed Central  Google Scholar 

Bera K, Schalper KA, Rimm DL, Velcheti V, Madabhushi A (2019) Artificial intelligence in digital pathology—new tools for diagnosis and precision oncology. Nat Rev Clin Oncol 16:703–715

Article  PubMed  PubMed Central  Google Scholar 

Bristol Myers Squibb (2022) OPDIVO® (nivolumab) [package insert]. https://packageinserts.bms.com/pi/pi_opdivo.pdf. Accessed 27 Mar 2024

Bristol Myers Squibb (2022) Yervoy®(ipilimumab) [package insert]. https://packageinserts.bms.com/pi/pi_yervoy.pdf. Accessed 27 Mar 2024

Büttner R, Gosney JR, Skov BG, Adam J, Motoi N, Bloom KJ, Dietel M, Longshore JW, López-Ríos F, Penault-Llorca F, Viale G, Wotherspoon AC, Kerr KM, Tsao M-S (2017) Programmed death-ligand 1 immunohistochemistry testing: A review of analytical assays and clinical implementation in non-small-cell lung cancer. J Clin Oncol 35:3867–3876. https://doi.org/10.1200/jco.2017.74.7642

Article  CAS  PubMed  Google Scholar 

CellCarta (2022) Pathotrainer: enabling pathology training and tuning in biomarker development. https://www.pathomation.com/pathotrainer-3/. Accessed 27 Mar 2024

Chen L-T, Satoh T, Ryu M-H, Chao Y, Kato K, Chung HC, Chen J-S, Muro K, Kang WK, Yeh K-H, Yoshikawa T, Oh SC, Bai L-Y, Tamura T, Lee K-W, Hamamoto Y, Kim JG, Chin K, Oh D-Y, Minashi K, Cho JY, Tsuda M, Sameshima H, Kang Y-K, Boku N (2020) A phase 3 study of nivolumab in previously treated advanced gastric or gastroesophageal junction cancer (ATTRACTION-2): 2-year update data. Gastric Cancer 23:510–519. https://doi.org/10.1007/s10120-019-01034-7

Article  CAS  PubMed  Google Scholar 

Cserni B, Bori R, Csörgő E, Oláh-Németh O, Pancsa T, Sejben A, Sejben I, Vörös A, Zombori T, Nyári T, Cserni G (2022) ONEST (Observers Needed to Evaluate Subjective Tests) suggests four or more observers for a reliable assessment of the consistency of histological grading of invasive breast carcinoma: A reproducibility study with a retrospective view on previous studies. Pathol Res Pract 229:153718. https://doi.org/10.1016/j.prp.2021.153718

Article  CAS  PubMed  Google Scholar 

Downes MR, Slodkowska E, Katabi N, Jungbluth AA, Xu B (2020) Inter- and intraobserver agreement of programmed death ligand 1 scoring in head and neck squamous cell carcinoma, urothelial carcinoma and breast carcinoma. Histopathology 76:191–200. https://doi.org/10.1111/his.13946

Article  PubMed  Google Scholar 

Eckstein M, Cimadamore A, Hartmann A, Lopez-Beltran A, Cheng L, Scarpelli M, Montironi R, Gevaert T (2019) PD-L1 assessment in urothelial carcinoma: a practical approach. Ann Transl Med 7:690. https://doi.org/10.21037/atm.2019.10.24

Article  CAS  PubMed  PubMed Central  Google Scholar 

Eckstein M, Erben P, Kriegmair MC, Worst TS, Weiß C-A, Wirtz RM, Wach S, Stoehr R, Sikic D, Geppert CI, Weyerer V, Bertz S, Breyer J, Otto W, Keck B, Burger M, Taubert H, Weichert W, Wullich B, Bolenz C, Hartmann A, Erlmeier F (2019) Performance of the Food and Drug Administration/EMA-approved programmed cell death ligand-1 assays in urothelial carcinoma with emphasis on therapy stratification for first-line use of atezolizumab and pembrolizumab. Eur J Cancer 106:234–243. https://doi.org/10.1016/j.ejca.2018.11.007

Article  CAS  PubMed  Google Scholar 

Eckstein M, Wirtz RM, Pfannstil C, Wach S, Stoehr R, Breyer J, Erlmeier F, Gunes C, Nitschke K, Weichert W, Otto W, Keck B, Eidt S, Burger M, Taubert H, Wullich B, Bolenz C, Hartmann A, Erben P (2018) A multicenter round robin test of PD-L1 expression assessment in urothelial bladder cancer by immunohistochemistry and RT-qPCR with emphasis on prognosis prediction after radical cystectomy. Oncotarget 9:15001–15014. https://doi.org/10.18632/oncotarget.24531

Article  PubMed  PubMed Central  Google Scholar 

Franklin C, Kader G, Mewborn D, Moreno J, Peck R, Perry M, Scheaffer R (2007) Guidelines for Assessment and Instruction in Statistics Education. https://web.archive.org/web/20130307004604/http:/www.amstat.org/education/gaise/GAISEPreK-12_Full.pdf. Accessed 27 Mar 2024

Fuchs CS, Doi T, Jang RW, Muro K, Satoh T, Machado M, Sun W, Jalal SI, Shah MA, Metges JP, Garrido M, Golan T, Mandala M, Wainberg ZA, Catenacci DV, Ohtsu A, Shitara K, Geva R, Bleeker J, Ko AH, Ku G, Philip P, Enzinger PC, Bang YJ, Levitan D, Wang J, Rosales M, Dalal RP, Yoon HH (2018) Safety and efficacy of pembrolizumab monotherapy in patients with previously treated advanced gastric and gastroesophageal junction cancer: phase 2 clinical keynote-059 trial. JAMA Oncol 4:e180013. https://doi.org/10.1001/jamaoncol.2018.0013

Article  PubMed  PubMed Central  Google Scholar 

Genentech Inc (2022) TECENTRIQ® (atezolizumab) [package insert]. https://www.gene.com/download/pdf/tecentriq_prescribing.pdf. Accessed 27 Mar 2024

Herbst RS, Baas P, Kim DW, Felip E, Perez-Gracia JL, Han JY, Molina J, Kim JH, Arvis CD, Ahn MJ, Majem M, Fidler MJ, de Castro G Jr, Garrido M, Lubiniecki GM, Shentu Y, Im E, Dolled-Filhart M, Garon EB (2016) Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial. Lancet 387:1540–1550. https://doi.org/10.1016/S0140-6736(15)01281-7

Article  CAS  PubMed  Google Scholar 

Hirsch FR, McElhinny A, Stanforth D, Ranger-Moore J, Jansson M, Kulangara K, Richardson W, Towne P, Hanks D, Vennapusa B, Mistry A, Kalamegham R, Averbuch S, Novotny J, Rubin E, Emancipator K, McCaffery I, Williams JA, Walker J, Longshore J, Tsao MS, Kerr KM (2017) PD-L1 immunohistochemistry assays for lung cancer: results from phase 1 of the Blueprint PD-L1 IHC assay comparison project. J Thorac Oncol 12:208–222. https://doi.org/10.1016/j.jtho.2016.11.2228

Article  PubMed  Google Scholar 

Kim B, Lee C, Kim YA, Moon KC (2020) PD-L1 expression in muscle-invasive urinary bladder urothelial carcinoma according to basal/squamous-like phenotype. Front Oncol 10:527385. https://doi.org/10.3389/fonc.2020.527385

Article  PubMed  PubMed Central  Google Scholar 

Larkin J, Chiarion-Sileni V, Gonzalez R, Grob JJ, Rutkowski P, Lao CD, Cowey CL, Schadendorf D, Wagstaff J, Dummer R, Ferrucci PF, Smylie M, Hogg D, Hill A, Marquez-Rodas I, Haanen J, Guidoboni M, Maio M, Schoffski P, Carlino MS, Lebbe C, McArthur G, Ascierto PA, Daniels GA, Long GV, Bastholt L, Rizzo JI, Balogh A, Moshyk A, Hodi FS, Wolchok JD (2019) Five-year survival with combined nivolumab and ipilimumab in advanced melanoma. N Engl J Med 381:1535–1546. https://doi.org/10.1056/NEJMoa1910836

Article  CAS  PubMed  Google Scholar 

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 (2020) Mapping the binding sites of antibodies utilized in programmed cell death ligand-1 predictive immunohistochemical assays for use with immuno-oncology therapies. Mod Pathol 33:518–530. https://doi.org/10.1038/s41379-019-0372-z

Article  CAS  PubMed  Google Scholar 

Lopez-Beltran A, Cimadamore A, Blanca A, Massari F, Vau N, Scarpelli M, Cheng L, Montironi R (2021) Immune checkpoint inhibitors for the treatment of bladder cancer. Cancers (Basel) 13:131. https://doi.org/10.3390/cancers13010131

Article  CAS  PubMed  PubMed Central  Google Scholar 

Mansour MSI, Hejny K, Johansson F, Mufti J, Vidis A, Mager U, Dejmek A, Seidal T, Brunnström H (2021) Factors influencing concordance of PD-L1 expression between biopsies and cytological specimens in non-small cell lung cancer. Diagnostics (Basel) 11:1927. https://doi.org/10.3390/diagnostics11101927

Article  CAS  PubMed  Google Scholar 

Mok TSK, Wu Y-L, Kudaba I, Kowalski DM, Chul Cho B, Turna HZ, Castro G Jr, Srimuninnimit V, Laktionov KK, Bondarenko I, Kubota K, Lubiniecki GM, Zhang J, Kush D, Lopes G, Investigators K- (2019) Pembrolizumab versus chemotherapy for previously untreated, PD-L1-expressing, locally advanced or metastatic non-small-cell lung cancer (KEYNOTE-042): a randomised, open-label, controlled, phase 3 trial. Lancet 393:1819–1830. https://doi.org/10.1016/s0140-6736(18)32409-7

Article  CAS  PubMed  Google Scholar 

National Comprehensive Cancer Network (2022) NCCN Clinical practice guidelines in oncology. Bladder cancer. https://www.nccn.org/professionals/physician_gls/pdf/bladder.pdf . Accessed 27 Mar 2024

Prince EA, Sanzari JK, Pandya D, Huron D, Edwards R (2021) Analytical concordance of PD-L1 assays utilizing antibodies from FDA-approved diagnostics in advanced cancers: A systematic literature review. JCO Precis Oncol 5:953–973. https://doi.org/10.1200/PO.20.00412

Article  PubMed  Google Scholar 

Rehman JA, Han G, Carvajal-Hausdorf DE, Wasserman BE, Pelekanou V, Mani NL, McLaughlin J, Schalper KA, Rimm DL (2017) Quantitative and pathologist-read comparison of the heterogeneity of programmed death-ligand 1 (PD-L1) expression in non-small cell lung cancer. Mod Pathol 30:340–349. https://doi.org/10.1038/modpathol.2016.186

Article  CAS  PubMed  Google Scholar 

Reisenbichler ES, Han G, Bellizzi A, Bossuyt V, Brock J, Cole K, Fadare O, Hameed O, Hanley K, Harrison BT, Kuba MG, Ly A, Miller D, Podoll M, Roden AC, Singh K, Sanders MA, Wei S, Wen H, Pelekanou V, Yaghoobi V, Ahmed F, Pusztai L, Rimm DL (2020) Prospective multi-institutional evaluation of pathologist assessment of PD-L1 assays for patient selection in triple negative breast cancer. Mod Pathol 33:1746–1752. https://doi.org/10.1038/s41379-020-0544-x

Article