2023
Multi-Institutional Study of Pathologist Reading of the Programmed Cell Death Ligand-1 Combined Positive Score Immunohistochemistry Assay for Gastric or Gastroesophageal Junction Cancer
Fernandez A, Robbins C, Gaule P, Agostini-Vulaj D, Anders R, Bellizzi A, Chen W, Chen Z, Gopal P, Zhao L, Lisovsky M, Liu X, Shia J, Wang H, Yang Z, McCann L, Chan Y, Weidler J, Bates M, Zhang X, Rimm D. Multi-Institutional Study of Pathologist Reading of the Programmed Cell Death Ligand-1 Combined Positive Score Immunohistochemistry Assay for Gastric or Gastroesophageal Junction Cancer. Modern Pathology 2023, 36: 100128. PMID: 36889057, PMCID: PMC10198879, DOI: 10.1016/j.modpat.2023.100128.Peer-Reviewed Original ResearchConceptsOverall percent agreementCut pointsReal-world settingHigher cut pointsCell death ligand 1Percent agreementGastroesophageal junction cancerPD-L1 immunohistochemistryDeath ligand 1Companion diagnostic testsMessenger RNA measurementsJunction cancerCancer casesImmunohistochemistry assaysIHC resultsDrug AdministrationPredictive valueScoring systemRange of assaysDiagnostic testsInstitutional studyRNA measurementsImmunohistochemistryPoor specificityPathologist's reading
2019
Quantitative assessment of PD-L1 as an analyte in immunohistochemistry diagnostic assays using a standardized cell line tissue microarray
Martinez-Morilla S, McGuire J, Gaule P, Moore L, Acs B, Cougot D, Gown AM, Yaziji H, Wang WL, Cartun RW, Hornick JL, Sholl LM, Qiu J, Mino-Kenudson M, Yi ES, Beasley MB, Merrick DT, Ambaye AB, Zhang ZJ, Walker J, Rimm DL. Quantitative assessment of PD-L1 as an analyte in immunohistochemistry diagnostic assays using a standardized cell line tissue microarray. Laboratory Investigation 2019, 100: 4-15. PMID: 31409885, PMCID: PMC6920558, DOI: 10.1038/s41374-019-0295-9.Peer-Reviewed Original ResearchConceptsTissue microarrayPD-L1Quantitative immunofluorescencePD-L1 expressionPD-L1 immunohistochemistryMulti-institutional settingRoutine clinical samplesCell linesPredictive markerClinical trialsTumor typesIHC assaysQuantitative digital image analysisImmunohistochemistryCut pointsClinical samplesAntibodiesFDAInter-assay comparisonsDiagnostic assaysIsogenic cell linesAssaysDigital image analysisSubjective assessmentLow levels“Interchangeability” of PD-L1 immunohistochemistry assays: a meta-analysis of diagnostic accuracy
Torlakovic E, Lim HJ, Adam J, Barnes P, Bigras G, Chan AWH, Cheung CC, Chung JH, Couture C, Fiset PO, Fujimoto D, Han G, Hirsch FR, Ilie M, Ionescu D, Li C, Munari E, Okuda K, Ratcliffe MJ, Rimm DL, Ross C, Røge R, Scheel AH, Soo RA, Swanson PE, Tretiakova M, To KF, Vainer GW, Wang H, Xu Z, Zielinski D, Tsao MS. “Interchangeability” of PD-L1 immunohistochemistry assays: a meta-analysis of diagnostic accuracy. Modern Pathology 2019, 33: 4-17. PMID: 31383961, PMCID: PMC6927905, DOI: 10.1038/s41379-019-0327-4.Peer-Reviewed Original ResearchConceptsPD-L1 assaysPD-L1Drug AdministrationDiagnostic accuracyDifferent PD-L1 assaysPD-L1 assessmentPD-L1 immunohistochemistryMain outcome measuresQUADAS-2 criteriaRandom-effects modelDiagnostic accuracy studiesOutcome measuresMEDLINE databaseSystematic reviewPubMed platformSystematic searchAdministrationSearch termsSTARD 2015Accuracy studiesPrimary objectiveAssaysData abstractionDifferent clonesFoodComparison of Biomarker Modalities for Predicting Response to PD-1/PD-L1 Checkpoint Blockade
Lu S, Stein JE, Rimm DL, Wang DW, Bell JM, Johnson DB, Sosman JA, Schalper KA, Anders RA, Wang H, Hoyt C, Pardoll DM, Danilova L, Taube JM. Comparison of Biomarker Modalities for Predicting Response to PD-1/PD-L1 Checkpoint Blockade. JAMA Oncology 2019, 5: 1195-1204. PMID: 31318407, PMCID: PMC6646995, DOI: 10.1001/jamaoncol.2019.1549.Peer-Reviewed Original ResearchAnti-PD-1/PD-L1 therapyPD-L1 immunohistochemistryTumor mutational burdenPD-L1 therapyGene expression profilingMutational burdenAnti-PD-1/PD-L1 treatmentPD-1/PD-L1 checkpoint blockadeAnti-PD-1/PD-L1Tumor typesPD-L1 checkpoint blockadeDifferent solid tumor typesPD-L1 treatmentPretreatment tumor tissueImmunotherapy of cancerDrug Administration approvalSearch of PubMedMeta-Analyses (PRISMA) guidelinesSolid tumor typesNegative predictive valuePreferred Reporting ItemsAnnual meeting abstractsNegative likelihood ratioRelative diagnostic performanceCheckpoint blockadeA Multi-Institutional Study to Evaluate Automated Whole Slide Scoring of Immunohistochemistry for Assessment of Programmed Death-Ligand 1 (PD-L1) Expression in Non–Small Cell Lung Cancer
Taylor CR, Jadhav AP, Gholap A, Kamble G, Huang J, Gown A, Doshi I, Rimm DL. A Multi-Institutional Study to Evaluate Automated Whole Slide Scoring of Immunohistochemistry for Assessment of Programmed Death-Ligand 1 (PD-L1) Expression in Non–Small Cell Lung Cancer. Applied Immunohistochemistry & Molecular Morphology 2019, 27: 263-269. PMID: 30640753, DOI: 10.1097/pai.0000000000000737.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerCell lung cancerImmune cellsTumor cellsLin's concordance correlation coefficientLung cancerProgrammed Death Ligand 1 ExpressionDako Link 48 platformDeath ligand 1 (PD-L1) expressionNon-small cell lung carcinomaPD-L1 expressionPD-L1 immunohistochemistryImmune cell populationsImmune cell expressionCell lung carcinomaCell scoringMulti-institutional studyConcordance correlation coefficientImage analysis scoresPD-L1Cell positivityLung carcinomaPatient managementSlide scoringCell expression
2017
Effects of neoadjuvant chemotherapy (NAC) on tumor infiltrating lymphocytes (TIL) and PD-L1 expression in the SWOG S0800 clinical trial.
Pelekanou V, Barlow W, von Wahlde M, Wasserman B, Lo Y, Hayes D, Hortobagyi G, Gralow J, Tripathy D, Livingston R, Porter P, Nahleh Z, Rimm D, Pusztai L. Effects of neoadjuvant chemotherapy (NAC) on tumor infiltrating lymphocytes (TIL) and PD-L1 expression in the SWOG S0800 clinical trial. Journal Of Clinical Oncology 2017, 35: 519-519. DOI: 10.1200/jco.2017.35.15_suppl.519.Peer-Reviewed Original ResearchPD-L1 expressionNeoadjuvant chemotherapyNAC armTIL countClinical trialsImmune parametersNAC samplesBaseline PD-L1 expressionPathologic complete response rateDose-dense doxorubicinComplete response ratePD-L1 immunohistochemistryHER2-negative casesMinority of casesNab-paclitaxelResidual diseaseMean changeResponse rateLogistic regressionTILsBaselineEpithelial cellsHigh PCRChemotherapyTumors