2023
Multi-institutional Assessment of Pathologist Scoring HER2 Immunohistochemistry
Robbins C, Fernandez A, Han G, Wong S, Harigopal M, Podoll M, Singh K, Ly A, Kuba M, Wen H, Sanders M, Brock J, Wei S, Fadare O, Hanley K, Jorns J, Snir O, Yoon E, Rabe K, Soong T, Reisenbichler E, Rimm D. Multi-institutional Assessment of Pathologist Scoring HER2 Immunohistochemistry. Modern Pathology 2023, 36: 100032. PMID: 36788069, PMCID: PMC10278086, DOI: 10.1016/j.modpat.2022.100032.Peer-Reviewed Original ResearchConceptsOverall percent agreementHuman epidermal growth factor 2HER2 IHCReal-world settingEpidermal growth factor 2HER2-negative statusBreast cancer biopsiesCompanion diagnostic testsMulti-institutional assessmentGrowth factor 2Breast cancerImmunohistochemistry assaysCancer biopsiesHER2 immunohistochemistryPathologist concordanceIHCClinical standardsPercent agreementDiagnostic testsSubstantial discordanceERBB2 geneInterrater reliabilityPathologistsFactor 2Concordance
2022
Examination of Low ERBB2 Protein Expression in Breast Cancer Tissue
Fernandez AI, Liu M, Bellizzi A, Brock J, Fadare O, Hanley K, Harigopal M, Jorns JM, Kuba MG, Ly A, Podoll M, Rabe K, Sanders MA, Singh K, Snir OL, Soong TR, Wei S, Wen H, Wong S, Yoon E, Pusztai L, Reisenbichler E, Rimm DL. Examination of Low ERBB2 Protein Expression in Breast Cancer Tissue. JAMA Oncology 2022, 8: 1-4. PMID: 35113160, PMCID: PMC8814969, DOI: 10.1001/jamaoncol.2021.7239.Peer-Reviewed Original ResearchConceptsBreast cancer biopsiesT-DXdCancer biopsiesLarge randomized clinical trialsRandomized clinical trialsERBB2 protein expressionCentral pathology laboratoryBreast cancer tissuesAmerican Pathologists surveysStudy of concordanceTrastuzumab deruxtecanERBB2 positivityPatient populationClinical trialsScore 0Breast cancerImmunohistochemistry scoreCancer tissuesIHC assaysPatientsPathology laboratoryProtein expressionBiopsyIHCConcordance
2020
Advances in quantitative immunohistochemistry and their contribution to breast cancer
Yaghoobi V, Martinez-Morilla S, Liu Y, Charette L, Rimm DL, Harigopal M. Advances in quantitative immunohistochemistry and their contribution to breast cancer. Expert Review Of Molecular Diagnostics 2020, 20: 509-522. PMID: 32178550, DOI: 10.1080/14737159.2020.1743178.Peer-Reviewed Original Research
2018
Immunological differences between primary and metastatic breast cancer
Szekely B, Bossuyt V, Li X, Wali VB, Patwardhan GA, Frederick C, Silber A, Park T, Harigopal M, Pelekanou V, Zhang M, Yan Q, Rimm DL, Bianchini G, Hatzis C, Pusztai L. Immunological differences between primary and metastatic breast cancer. Annals Of Oncology 2018, 29: 2232-2239. PMID: 30203045, DOI: 10.1093/annonc/mdy399.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAgedAntineoplastic Agents, ImmunologicalB7-H1 AntigenBiomarkers, TumorBiopsyBreast NeoplasmsDisease ProgressionDrug Resistance, NeoplasmFemaleGene Expression RegulationHumansImmunologic SurveillanceLymphocyte CountLymphocytes, Tumor-InfiltratingMiddle AgedMutation RateTumor EscapeTumor MicroenvironmentYoung AdultConceptsMetastatic breast cancerBreast cancerTherapeutic targetToll-like receptor pathway genesImmuno-oncology therapeutic targetsBreast cancer evolvesImmune proteasome expressionPD-L1 positivityCorresponding primary tumorsPotential therapeutic targetMHC class IImmune-related genesMetastatic cancer samplesLigand/receptor pairLymphocyte countT helperT-regsPD-L1Immune microenvironmentCytotoxic TPrimary tumorMastoid cellsDisease progressionTherapeutic combinationsMacrophage markers
2016
Automated measurement of estrogen receptor in breast cancer: a comparison of fluorescent and chromogenic methods of measurement
Zarrella ER, Coulter M, Welsh AW, Carvajal DE, Schalper KA, Harigopal M, Rimm D, Neumeister V. Automated measurement of estrogen receptor in breast cancer: a comparison of fluorescent and chromogenic methods of measurement. Laboratory Investigation 2016, 96: 1016-1025. PMID: 27348626, PMCID: PMC5008858, DOI: 10.1038/labinvest.2016.73.Peer-Reviewed Original Research
2013
Quantitative Analysis of Estrogen Receptor Expression Shows SP1 Antibody Is More Sensitive Than 1D5
Welsh AW, Harigopal M, Wimberly H, Prasad M, Rimm DL. Quantitative Analysis of Estrogen Receptor Expression Shows SP1 Antibody Is More Sensitive Than 1D5. Applied Immunohistochemistry & Molecular Morphology 2013, 21: 139-147. PMID: 22820659, PMCID: PMC3482297, DOI: 10.1097/pai.0b013e31825d73b2.Peer-Reviewed Original Research
2011
Standardization of Estrogen Receptor Measurement in Breast Cancer Suggests False-Negative Results Are a Function of Threshold Intensity Rather Than Percentage of Positive Cells
Welsh AW, Moeder CB, Kumar S, Gershkovich P, Alarid ET, Harigopal M, Haffty BG, Rimm DL. Standardization of Estrogen Receptor Measurement in Breast Cancer Suggests False-Negative Results Are a Function of Threshold Intensity Rather Than Percentage of Positive Cells. Journal Of Clinical Oncology 2011, 29: 2978-2984. PMID: 21709197, PMCID: PMC3157961, DOI: 10.1200/jco.2010.32.9706.Peer-Reviewed Original ResearchConceptsER-positive patientsEstrogen receptorQuantitative immunofluorescenceBreast cancerTissue microarrayPositive cellsIndependent retrospective cohortsEstrogen receptor measurementsAssessment of survivalTMA cohortFalse-negative resultsRetrospective cohortER immunoreactivityTest discordancePrognostic outcomesIndependent cohortReceptor measurementsLimitations of immunohistochemistryPatientsDiscrepant casesCohortIHC methodPathologists' judgmentsDiscrepant resultsStandardized assays
2010
Multiplexed Assessment of the Southwest Oncology Group-Directed Intergroup Breast Cancer Trial S9313 by AQUA Shows that Both High and Low Levels of HER2 Are Associated with Poor Outcome
Harigopal M, Barlow WE, Tedeschi G, Porter PL, Yeh IT, Haskell C, Livingston R, Hortobagyi GN, Sledge G, Shapiro C, Ingle JN, Rimm DL, Hayes DF. Multiplexed Assessment of the Southwest Oncology Group-Directed Intergroup Breast Cancer Trial S9313 by AQUA Shows that Both High and Low Levels of HER2 Are Associated with Poor Outcome. American Journal Of Pathology 2010, 176: 1639-1647. PMID: 20150438, PMCID: PMC2843456, DOI: 10.2353/ajpath.2010.090711.Peer-Reviewed Original ResearchConceptsDisease-free survivalEstrogen receptorContinuous variablesSouthwest Oncology GroupAQUA methodAC chemotherapyMenopausal statusNegative patientsOncology GroupNode statusSequential doxorubicinPoor outcomeTumor sizeProgesterone receptorPrognostic informationWorse outcomesTissue biomarkersTissue microarrayBiphasic effectP53 expressionPatientsHER2Low expressersDiagnostic approachMultiplexed assessment
2009
Multiplexed AQUA-based assessment of SWOG 9313 shows prognostic value of continuous ER, PR and HER2 assessment.
Rimm D, Barlow W, Harigopal M, Tedeschi G, Peggy P, Yeh I, Haskell C, Livingston R, Hortobagyi G, Hayes D. Multiplexed AQUA-based assessment of SWOG 9313 shows prognostic value of continuous ER, PR and HER2 assessment. Cancer Research 2009, 69: 704. DOI: 10.1158/0008-5472.sabcs-704.Peer-Reviewed Original ResearchDisease-free survivalEstrogen receptorHER2 expressionWorse disease-free survivalPoor disease-free survivalContinuous variablesLow HER2 expressionPoor prognostic markerBreast cancer casesBreast cancer therapyBi-phasic effectSame slideHazard ratioMenopausal statusNode statusSequential doxorubicinPoor outcomePrognostic valueTumor sizePrognostic informationWorse outcomesPrognostic markerBreast cancerCancer casesTissue microarray
2008
Estrogen receptor co-activator (AIB1) protein expression by automated quantitative analysis (AQUA) in a breast cancer tissue microarray and association with patient outcome
Harigopal M, Heymann J, Ghosh S, Anagnostou V, Camp RL, Rimm DL. Estrogen receptor co-activator (AIB1) protein expression by automated quantitative analysis (AQUA) in a breast cancer tissue microarray and association with patient outcome. Breast Cancer Research And Treatment 2008, 115: 77-85. PMID: 18521745, DOI: 10.1007/s10549-008-0063-9.Peer-Reviewed Original ResearchMeSH KeywordsAlgorithmsAutomationBiomarkers, TumorBreast NeoplasmsFemaleGene Expression Regulation, NeoplasticHumansMultivariate AnalysisNuclear Receptor Coactivator 3Oligonucleotide Array Sequence AnalysisPrognosisProportional Hazards ModelsReceptors, EstrogenReceptors, ProgesteroneRegression AnalysisTranscription FactorsTreatment OutcomeConceptsHigh AIB1 expressionTranscription intermediary factor 2Poor patient outcomesAIB1 expressionTissue microarrayPatient outcomesHER2/neu statusBreast cancer tissue microarrayFluorescent immunohistochemical stainingWorse overall survivalUnivariate survival analysisBreast cancer specimensCancer tissue microarrayHER2/neuCoregulatory proteinsCox univariate survival analysesBreast tissue microarraysOverall survivalER statusPR statusPrognostic significanceIndependent associationBreast cancerPrognostic biomarkerImmunohistochemical staining
2007
Quantitative Justification of the Change From 10% to 30% for Human Epidermal Growth Factor Receptor 2 Scoring in the American Society of Clinical Oncology/College of American Pathologists Guidelines: Tumor Heterogeneity in Breast Cancer and Its Implications for Tissue Microarray–Based Assessment of Outcome
Moeder CB, Giltnane JM, Harigopal M, Molinaro A, Robinson A, Gelmon K, Huntsman D, Camp RL, Rimm DL. Quantitative Justification of the Change From 10% to 30% for Human Epidermal Growth Factor Receptor 2 Scoring in the American Society of Clinical Oncology/College of American Pathologists Guidelines: Tumor Heterogeneity in Breast Cancer and Its Implications for Tissue Microarray–Based Assessment of Outcome. Journal Of Clinical Oncology 2007, 25: 5418-5425. PMID: 18048824, DOI: 10.1200/jco.2007.12.8033.Peer-Reviewed Original ResearchBimodal Population or Pathologist Artifact?
Rimm DL, Giltnane JM, Moeder C, Harigopal M, Chung GG, Camp RL, Burtness B. Bimodal Population or Pathologist Artifact? Journal Of Clinical Oncology 2007, 25: 2487-2488. PMID: 17557963, DOI: 10.1200/jco.2006.07.7537.Peer-Reviewed Original ResearchVariation in breast cancer hormone receptor and HER2 levels by etiologic factors: A population‐based analysis
Sherman ME, Rimm DL, Yang XR, Chatterjee N, Brinton LA, Lissowska J, Peplonska B, Szeszenia‐Dąbrowska N, Zatonski W, Cartun R, Mandich D, Rymkiewicz G, Ligaj M, Lukaszek S, Kordek R, Kalaylioglu Z, Harigopal M, Charrette L, Falk RT, Richesson D, Anderson WF, Hewitt SM, García‐Closas M. Variation in breast cancer hormone receptor and HER2 levels by etiologic factors: A population‐based analysis. International Journal Of Cancer 2007, 121: 1079-1085. PMID: 17487843, DOI: 10.1002/ijc.22812.Peer-Reviewed Original ResearchConceptsBody mass indexPostmenopausal womenEtiologic factorsHER2 levelsPremenopausal womenOdds ratioER alphaBreast cancer hormone receptor statusPopulation-based case-control studyBreast Cancer Hormone ReceptorsHormone receptor statusCase-control studyPopulation-based analysisPathologic characteristicsPR statusReceptor statusMass indexER betaClinical recordsMarker levelsHER2 expressionLarge tumorsBreast cancerReceptor levelsTumor features
2006
Classification of Breast Cancer Using Genetic Algorithms and Tissue Microarrays
Dolled-Filhart M, Rydén L, Cregger M, Jirström K, Harigopal M, Camp RL, Rimm DL. Classification of Breast Cancer Using Genetic Algorithms and Tissue Microarrays. Clinical Cancer Research 2006, 12: 6459-6468. PMID: 17085660, DOI: 10.1158/1078-0432.ccr-06-1383.Peer-Reviewed Original ResearchConceptsBreast cancerPatient outcomesTissue microarraySubset of patientsBreast cancer patientsTissue microarray platformInternal validation setRoutine pathology laboratoriesCancer patientsEstrogen receptorTissue biomarkersIndependent cohortTumor subtypesPredictive valueAcid-base analysisPathology laboratoryRNA expression studiesCancerTissue sectionsPatientsCohortOutcomesFurther validationObjective quantitative analysisBiomarker discoveryVascular endothelial growth factor, FLT‐1, and FLK‐1 analysis in a pancreatic cancer tissue microarray
Chung GG, Yoon HH, Zerkowski MP, Ghosh S, Thomas L, Harigopal M, Charette LA, Salem RR, Camp RL, Rimm DL, Burtness BA. Vascular endothelial growth factor, FLT‐1, and FLK‐1 analysis in a pancreatic cancer tissue microarray. Cancer 2006, 106: 1677-1684. PMID: 16532435, DOI: 10.1002/cncr.21783.Peer-Reviewed Original ResearchConceptsPancreatic cancer tissue microarrayCancer tissue microarrayTissue microarrayVEGF receptor 1Flt-1Receptor 1Kaplan-Meier survival curvesVascular endothelial growth factor (VEGF) expressionIndependent prognostic factorVascular endothelial growth factorFlk-1Growth factor expressionEndothelial growth factorPrimary antibodyFlt-1 expressionOverall survivalPrognostic factorsWorse survivalAggressive diseaseDisease stagePoor prognosisTumor expressionPancreatic cancerPancreatic adenocarcinomaPrincipal receptorMolecular Classification Identifies a Subset of Human Papillomavirus–Associated Oropharyngeal Cancers With Favorable Prognosis
Weinberger PM, Yu Z, Haffty BG, Kowalski D, Harigopal M, Brandsma J, Sasaki C, Joe J, Camp RL, Rimm DL, Psyrri A. Molecular Classification Identifies a Subset of Human Papillomavirus–Associated Oropharyngeal Cancers With Favorable Prognosis. Journal Of Clinical Oncology 2006, 24: 736-747. PMID: 16401683, DOI: 10.1200/jco.2004.00.3335.Peer-Reviewed Original ResearchConceptsOropharyngeal squamous cell carcinomaHuman papillomavirusFavorable prognosisClass IIILocal recurrencePrognostic valueHuman Papillomavirus–Associated Oropharyngeal CancerHPV DNA presenceHPV16 viral loadDisease-free survivalMultivariable survival analysisSquamous cell carcinomaLong-term patientsThree-class modelReal-time polymerase chain reactionHPV statusLow p53Only patientsOverall survivalOropharyngeal cancerViral loadCell carcinomaPolymerase chain reactionClinical trialsP16 overexpression
2005
Automated Quantitative Analysis of E-Cadherin Expression in Lymph Node Metastases Is Predictive of Survival in Invasive Ductal Breast Cancer
Harigopal M, Berger AJ, Camp RL, Rimm DL, Kluger HM. Automated Quantitative Analysis of E-Cadherin Expression in Lymph Node Metastases Is Predictive of Survival in Invasive Ductal Breast Cancer. Clinical Cancer Research 2005, 11: 4083-4089. PMID: 15930343, DOI: 10.1158/1078-0432.ccr-04-2191.Peer-Reviewed Original ResearchConceptsE-cadherin expressionLymph node metastasisNodal metastasisBreast cancerImproved survivalNode metastasisTissue microarrayNode-positive breast cancerInvasive ductal breast cancerHER2/neu statusAnti-invasive roleInvasive ductal tumorsNode-positive patientsDuctal breast cancerSubset of patientsGood prognostic markerAggressive tumor behaviorStrong E-cadherin expressionHigh E-cadherin expressionCy5-conjugated antibodiesDuctal tumorsMetastatic sitesPrognostic valueTumor sizePrimary tumorβ1,6-Branched Oligosaccharides Are Increased in Lymph Node Metastases and Predict Poor Outcome in Breast Carcinoma
Handerson T, Camp R, Harigopal M, Rimm D, Pawelek J. β1,6-Branched Oligosaccharides Are Increased in Lymph Node Metastases and Predict Poor Outcome in Breast Carcinoma. Clinical Cancer Research 2005, 11: 2969-2973. PMID: 15837749, DOI: 10.1158/1078-0432.ccr-04-2211.Peer-Reviewed Original ResearchConceptsLymph node metastasisPrimary tumorNode metastasisPoor outcomeBreast carcinomaNode-positive primary tumorsPatient-matched primary tumorsNode-negative tumorsBreast carcinoma metastasisPatient ageNodal metastasisTumor sizeRisk factorsNuclear gradeCarcinoma metastasisTissue microarrayBlinded observersMyeloid cellsMetastasisMultivariate analysisTumor progressionTumorsSystemic migrationCancer cellsLectin histochemistry
2004
Prognostic Significance of p16 Protein Levels in Oropharyngeal Squamous Cell Cancer
Weinberger PM, Yu Z, Haffty BG, Kowalski D, Harigopal M, Sasaki C, Rimm DL, Psyrri A. Prognostic Significance of p16 Protein Levels in Oropharyngeal Squamous Cell Cancer. Clinical Cancer Research 2004, 10: 5684-5691. PMID: 15355894, DOI: 10.1158/1078-0432.ccr-04-0448.Peer-Reviewed Original ResearchConceptsSquamous cell cancerOropharyngeal squamous cell carcinomaOropharyngeal squamous cell cancerDisease-free survivalLocal recurrence rateSquamous cell carcinomaCell cancerOverall survivalRecurrence rateCell carcinomaP16 overexpressionNeck squamous cell cancerLow local recurrence rateAdvanced Tumor-NodeMean patient followIndependent prognostic factorHigh histologic gradeP16 expression statusOverexpression of p16Local recurrencePrognostic factorsPrognostic importanceP16 protein expressionPrognostic significanceHistologic gradeMolecular predictors for response to carboplatinum and paclitaxel (CP) chemotherapy in patients with ovarian cancer
Psyrri A, Bamias A, Yu Z, Markakis S, Kowalski D, Weinberger P, Harigopal M, Efstathiou E, Rimm D, Dimopoulos M. Molecular predictors for response to carboplatinum and paclitaxel (CP) chemotherapy in patients with ovarian cancer. Journal Of Clinical Oncology 2004, 22: 5066-5066. DOI: 10.1200/jco.2004.22.14_suppl.5066.Peer-Reviewed Original Research
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