2020
TBCRC 030: a phase II study of preoperative cisplatin versus paclitaxel in triple-negative breast cancer: evaluating the homologous recombination deficiency (HRD) biomarker
Mayer EL, Abramson V, Jankowitz R, Falkson C, Marcom PK, Traina T, Carey L, Rimawi M, Specht J, Miller K, Stearns V, Tung N, Perou C, Richardson AL, Componeschi K, Trippa L, Tan-Wasielewski Z, Timms K, Krop I, Wolff AC, Winer EP. TBCRC 030: a phase II study of preoperative cisplatin versus paclitaxel in triple-negative breast cancer: evaluating the homologous recombination deficiency (HRD) biomarker. Annals Of Oncology 2020, 31: 1518-1525. PMID: 32798689, PMCID: PMC8437015, DOI: 10.1016/j.annonc.2020.08.2064.Peer-Reviewed Original ResearchConceptsTriple-negative breast cancerHomologous recombination deficiencyPhase II studyPathologic responsePreoperative cisplatinII studyBreast cancerProspective phase II studyEffective predictive biomarkersInadequate clinical responsePreoperative chemotherapy regimenSingle-agent cisplatinHomologous recombination deficiency biomarkersGermline BRCA1/2Preoperative paclitaxelChemotherapy regimenClinical responseCisplatin chemotherapyPredictive biomarkersAlternative chemotherapyPreoperative trialInadequate responseHRD scoreStage IBaseline tissue
2019
Current Landscape of Immunotherapy in Breast Cancer
Adams S, Gatti-Mays ME, Kalinsky K, Korde LA, Sharon E, Amiri-Kordestani L, Bear H, McArthur HL, Frank E, Perlmutter J, Page DB, Vincent B, Hayes JF, Gulley JL, Litton JK, Hortobagyi GN, Chia S, Krop I, White J, Sparano J, Disis ML, Mittendorf EA. Current Landscape of Immunotherapy in Breast Cancer. JAMA Oncology 2019, 5: 1205-1214. PMID: 30973611, PMCID: PMC8452050, DOI: 10.1001/jamaoncol.2018.7147.Peer-Reviewed Original ResearchImmune checkpoint blockadeBreast cancerForm of immunotherapyLocal ablative therapyRobust predictive biomarkersCancer immunotherapy trialsAppropriate end pointsCombination therapy strategiesAdditional chemotherapeutic agentsCheckpoint blockadeMetastatic diseaseObjective responseImmunotherapy trialsClinical efficacyAblative therapyPredictive biomarkersClinical trialsImmune responseThoughtful study designImmunotherapyBreast tumorsChemotherapeutic agentsNarrative reviewCancerEnd pointGenomic correlates of response to adjuvant trastuzumab (H) and pertuzumab (P) in HER2+ breast cancer (BC): Biomarker analysis of the APHINITY trial.
Krop I, Paulson J, Campbell C, Kiermaier A, Andre F, Fumagalli D, de Haas S, Salgado R, Denkert C, Loibl S, Bailey A, Lewis Phillips G, Frank E, Piccart M, Viale G, Loi S. Genomic correlates of response to adjuvant trastuzumab (H) and pertuzumab (P) in HER2+ breast cancer (BC): Biomarker analysis of the APHINITY trial. Journal Of Clinical Oncology 2019, 37: 1012-1012. DOI: 10.1200/jco.2019.37.15_suppl.1012.Peer-Reviewed Original ResearchTumor-Infiltrating LymphocytesBreast cancerBetter prognosisComprehensive biomarker analysisPhase III studyInteraction p valueCase-control designBiomarker analysisHigher mRNA expressionAnthracycline useAPHINITY trialAdjuvant trastuzumabChemotherapy typeIII studyImmune signaturesNodal statusImmune markersInfiltrating lymphocytesClinical parametersPoor prognosisPredictive biomarkersTIL analysisBetter outcomesPAM50 subtypesPrognosisGenomic-based predictive biomarkers to anti-HER2 therapies: A combined analysis of CALGB 40601 (Alliance) and PAMELA clinical trials.
Fernandez-Martinez A, Tanioka M, Fan C, Parker J, Hoadley K, Krop I, Cortes J, Llombart Cussac A, Nuciforo P, Galván P, Pascual T, Partridge A, Prat A, Carey L, Perou C. Genomic-based predictive biomarkers to anti-HER2 therapies: A combined analysis of CALGB 40601 (Alliance) and PAMELA clinical trials. Journal Of Clinical Oncology 2019, 37: 571-571. DOI: 10.1200/jco.2019.37.15_suppl.571.Peer-Reviewed Original ResearchHER2-E subtypeCALGB 40601Clinical trialsPredictive biomarkersIntrinsic subtypesEvent-free survival analysisHER2-positive breast cancerAnti-HER2 combinationDual HER2 blockadeAnti-HER2 therapyAnti-HER2 treatmentIndependent predictive biomarkerFree survival analysisPre-treatment tumorsERBB2 mRNA levelsHER2 blockadeLuminal signatureNeoadjuvant settingPCR rateIndependent predictorsLuminal ALuminal BSubtype distributionBreast cancerERBB2 mRNA
2015
Role of vascular density and normalization in response to neoadjuvant bevacizumab and chemotherapy in breast cancer patients
Tolaney SM, Boucher Y, Duda DG, Martin JD, Seano G, Ancukiewicz M, Barry WT, Goel S, Lahdenrata J, Isakoff SJ, Yeh ED, Jain SR, Golshan M, Brock J, Snuderl M, Winer EP, Krop IE, Jain RK. Role of vascular density and normalization in response to neoadjuvant bevacizumab and chemotherapy in breast cancer patients. Proceedings Of The National Academy Of Sciences Of The United States Of America 2015, 112: 14325-14330. PMID: 26578779, PMCID: PMC4655544, DOI: 10.1073/pnas.1518808112.Peer-Reviewed Original ResearchConceptsPathologic complete responseBreast cancer patientsMicrovascular densityInterstitial fluid pressureNeoadjuvant bevacizumabBevacizumab monotherapyPathologic responseCancer patientsImproved pathologic responsePhase II studyPotential predictive biomarkersHER2-negative BCBasal-like subtypePreoperative bevacizumabPaclitaxel chemotherapyII studyComplete responseCombination therapyPredictive biomarkersPlasma biomarkersVascular normalizationBevacizumabVascular densityNew therapiesTissue biopsiesThe Evolving Landscape of HER2 Targeting in Breast Cancer
Moasser MM, Krop IE. The Evolving Landscape of HER2 Targeting in Breast Cancer. JAMA Oncology 2015, 1: 1154. PMID: 26204261, DOI: 10.1001/jamaoncol.2015.2286.Peer-Reviewed Original ResearchConceptsTreatment of HER2Breast cancerImmunologic effectorsHER2 targetingSubstantial single-agent activityHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Value of HER2Lines of therapyGrowth factor receptor 2Single-agent activityLate-stage diseaseStage of diseaseUseful predictive biomarkerHER2 inhibitor lapatinibFactor receptor 2Variety of cytotoxicModest efficacyTrastuzumab resistancePredictive biomarkersCell surface expressionImmunologic activityInhibitor lapatinibReceptor 2Advanced stage
2010
Ethics of Mandatory Research Biopsy for Correlative End Points Within Clinical Trials in Oncology
Peppercorn J, Shapira I, Collyar D, Deshields T, Lin N, Krop I, Grunwald H, Friedman P, Partridge AH, Schilsky RL, Bertagnolli MM. Ethics of Mandatory Research Biopsy for Correlative End Points Within Clinical Trials in Oncology. Journal Of Clinical Oncology 2010, 28: 2635-2640. PMID: 20406927, PMCID: PMC5596502, DOI: 10.1200/jco.2009.27.2443.Peer-Reviewed Original ResearchConceptsResearch biopsiesResearch participantsVoluntary informed consentCorrelative end pointsEthical concernsRisk of harmScientific questionsEthics CommitteeClinical trialsInformed consentInformed adultsScientific issuesEnd pointConsentClinical investigatorsCancer clinical trialsQuestionsEthicsPredictive biomarkersBiopsyIssuesCancer tissuesConductNovel interventionsBiologic basis
2009
Comparison of the Cellsearch Profile Kit (CPK) with the Standard Cellsearch Epithelial Kit (CEK) Demonstrates the CPK Produces Higher Circulating Tumor Cell (CTC) Yields and Is Better Suited for Use in Obtaining CTC's for Molecular Characterization.
Flores L, Kindelberger D, Ligon A, Cappeletti M, Fiorentino M, Loda M, Cibas E, Janne P, Krop I. Comparison of the Cellsearch Profile Kit (CPK) with the Standard Cellsearch Epithelial Kit (CEK) Demonstrates the CPK Produces Higher Circulating Tumor Cell (CTC) Yields and Is Better Suited for Use in Obtaining CTC's for Molecular Characterization. Cancer Research 2009, 69: 3003-3003. DOI: 10.1158/0008-5472.sabcs-09-3003.Peer-Reviewed Original ResearchML of bloodTumor cellsBreast cancerCytospin slidesLow intrapatient variabilityHER2 gene copy numberMetastatic breast cancerPeripheral blood samplesBC cell linesMedian cell countTumor cell yieldMean total numberMetastatic tumor cellsPrimary cancerCD45 stainingPredictive biomarkersMechanisms of resistanceHealthy controlsIntrapatient variabilityMetastatic cancerCTC yieldPharmacodynamic studiesSolid cancersCytokeratin stainingBlood samples