2025
Impact of Anthracyclines in Genomic High Risk, Node-Negative, HR-Positive/HER2-Negative Breast Cancer
Chen N, Freeman J, Yarlagadda S, Atmakuri A, Kalinsky K, Pusztai L, Sparano J, Huo D, Nanda R, Howard F. Impact of Anthracyclines in Genomic High Risk, Node-Negative, HR-Positive/HER2-Negative Breast Cancer. Annals Of Oncology 2025 PMID: 40972946, DOI: 10.1016/j.annonc.2025.08.002.Peer-Reviewed Original ResearchDistant recurrence-free intervalDistant recurrence-free survivalRecurrence scoreOverall survivalBreast cancerAnthracycline benefitHR-positive/HER2-negative breast cancerTaxane-based adjuvant chemotherapyBenefit of anthracyclinesGenomic high riskImpact of anthracyclinesRecurrence-free intervalRecurrence-free survivalTaxane-based chemotherapyHR+/HER2- breast cancerAdjuvant chemotherapy treatmentNodal statusNode-negativeReceptor statusAdjuvant chemotherapyClinicopathological factorsTumor sizeRisk diseaseHazard ratioChemotherapy treatment
2024
Race and clinical outcomes in hormone receptor-positive, HER2-negative, node-positive breast cancer in the randomized RxPONDER trial
Abdou Y, Barlow W, Gralow J, Meric-Bernstam F, Albain K, Hayes D, Lin N, Perez E, Goldstein L, Chia S, Dhesy-Thind S, Rastogi P, Alba E, Delaloge S, Schott A, Shak S, Sharma P, Lew D, Miao J, Unger J, Tripathy D, Hortobagyi G, Pusztai L, Kalinsky K. Race and clinical outcomes in hormone receptor-positive, HER2-negative, node-positive breast cancer in the randomized RxPONDER trial. Journal Of The National Cancer Institute 2024, 117: 889-897. PMID: 39656951, PMCID: PMC12058262, DOI: 10.1093/jnci/djae314.Peer-Reviewed Original ResearchInvasive disease-free survivalHormone receptor-positiveRecurrence scoreRxPONDER trialClinical outcomesReceptor-positiveBreast cancerHER2-negative breast cancerNode-positive breast cancerDisease-free survivalMultivariate Cox modelBreast cancer outcomesBody mass indexHER2-negativePositive nodesTumor sizeSurvival outcomesClinicopathological characteristicsClinical characteristicsMass indexSelf-reported race/ethnicityCancer outcomesSecondary outcomesNHB womenTreatment efficacyDevelopment and Validation of the RSClinN+ Tool to Predict Prognosis and Chemotherapy Benefit for Hormone Receptor–Positive, Node-Positive Breast Cancer
Pusztai L, Hoag J, Albain K, Barlow W, Stemmer S, Meisner A, Hortobagyi G, Shak S, Rae J, Baehner R, Sharma P, Kalinsky K. Development and Validation of the RSClinN+ Tool to Predict Prognosis and Chemotherapy Benefit for Hormone Receptor–Positive, Node-Positive Breast Cancer. Journal Of Clinical Oncology 2024, 43: 919-928. PMID: 39621968, PMCID: PMC11885031, DOI: 10.1200/jco-24-01507.Peer-Reviewed Original ResearchChemoendocrine therapyRecurrence scorePostmenopausal womenClinicopathological factorsClinicopathological modelOncotype DX Breast Recurrence ScoreLymph node-positive breast cancerInvasive disease-free survivalNode-positive breast cancerHormone receptor-positiveNode-positive diseaseDisease-free survivalCox proportional hazards regression modelsIndividual recurrence riskProportional hazards regression modelsRisk estimatesHealth Service RegistryEstimation of prognosisHazards regression modelsPremenopausal patientsEndocrine therapyReceptor-positiveChemotherapy benefitMenopausal statusPatient-level dataVentral hernia repair with permanent mesh for non-Hispanic black versus white patients: access and post-operative outcomes in the era of robotic surgery
Chao G, Ying L, Huang L, Ma J, Ghiassi S, Gibbs K, Nadzam G, Morton J, Duffy A, Zhou R. Ventral hernia repair with permanent mesh for non-Hispanic black versus white patients: access and post-operative outcomes in the era of robotic surgery. Surgical Endoscopy 2024, 39: 560-567. PMID: 39433584, DOI: 10.1007/s00464-024-11252-5.Peer-Reviewed Original ResearchRobotic surgeryVentral hernia repairBlack patientsHernia repairPermanent meshT-scoreEra of robotic surgeryAbdominal Core Health Quality CollaborativeRate of laparoscopyHigher pain scoresPatient outcomesPost-operative outcomesSurgical site infectionPropensity-score matchingVentral hernia surgeryRecurrence scoreChi-square testPain scoresSite infectionFisher's exactHernia recurrenceOpen approachHernia surgeryWhite patientsSurgeryCorrelating Predicted Adjuvant Therapy Benefit and Risk of Recurrence Between Breast Cancer Index (BCI) and the 21-Gene Oncotype DX Recurrence Score (RS)
Casasanta N, Patel R, Raymond S, Kier M, Blanter J, Sohval S, Hovstadius M, Wu C, Zimmerman B, Cascetta K, Bagiella E, Tiersten A. Correlating Predicted Adjuvant Therapy Benefit and Risk of Recurrence Between Breast Cancer Index (BCI) and the 21-Gene Oncotype DX Recurrence Score (RS). Clinical Breast Cancer 2024, 24: 585-596. PMID: 38971641, DOI: 10.1016/j.clbc.2024.06.005.Peer-Reviewed Original ResearchBreast Cancer IndexEarly-stage breast cancerOncotype DX RSAssociated with discordanceOncotype DX recurrence scoreAdjuvant therapy benefitReview of womenOncotype DXRecurrence scoreRecurrence riskEndocrine therapyCancer indexRetrospective chart review of womenChart review of womenRetrospective review of womenRisk of distant recurrenceTherapy benefitRisk of recurrenceRetrospective chart reviewRegression modelsUnivariate logistic regression modelLogistic regression modelsPrediction scoreDistant recurrenceAdjuvant therapyRecurrence score gene axes scores and outcomes by race and ethnicity in the RxPONDER trial.
Abdou Y, Hoag J, Barlow W, Gralow J, Meric-Bernstam F, Albain K, Hayes D, Lin N, Perez E, Goldstein L, Chia S, Dhesy-Thind S, Rastogi P, Schott A, Racz J, Tripathy D, Hortobagyi G, Pusztai L, Sharma P, Kalinsky K. Recurrence score gene axes scores and outcomes by race and ethnicity in the RxPONDER trial. Journal Of Clinical Oncology 2024, 42: 515-515. DOI: 10.1200/jco.2024.42.16_suppl.515.Peer-Reviewed Original ResearchInvasive disease-free survivalNon-Hispanic whitesRecurrence scoreRacial/ethnic groupsTumor biologyRxPONDER trialNon-Hispanic Black (NHBBreast cancer outcomesDisease-free survivalMedian Follow-UpCox regression modelsAssociated with outcomeCancer-related genesSignificant healthcare concernCancer outcomesMenopausal statusPrognostic valueInferior outcomesHER2 signalingUnadjusted analysisTreatment armsFollow-upImpact of raceNHBHER2Development and validation of RSClin N+ tool for hormone receptor-positive (HR+), HER2-negative (HER2-), node-positive breast cancer.
Pusztai L, Hoag J, Albain K, Barlow W, Stemmer S, Meisner A, Hortobagyi G, Shak S, Hayes D, Rae J, Baehner F, Sharma P, Kalinsky K. Development and validation of RSClin N+ tool for hormone receptor-positive (HR+), HER2-negative (HER2-), node-positive breast cancer. Journal Of Clinical Oncology 2024, 42: 508-508. DOI: 10.1200/jco.2024.42.16_suppl.508.Peer-Reviewed Original ResearchChemoendocrine therapyRecurrence scoreClinicopathological factorsBreast cancerPostmenopausal patientsNode-negative breast cancerNode-positive breast cancerHormone receptor-positiveNode-positive diseaseHR+/HER2- breast cancerRisk estimatesHigh-risk patientsEstimating 5-year riskEstimation of recurrence riskLikelihood ratioPremenopausal patientsHER2-negativeReceptor-positiveChemotherapy benefitEndocrine therapyMenopausal statusRisk patientsInvasive diseasePrognostic informationPostmenopausal modelCorrelation of serum anti-Müllerian hormone (AMH) levels on identification of premenopausal patients (pts) with hormone receptor positive (HR+), HER2-negative, node-positive breast cancer most likely to benefit from adjuvant chemotherapy in SWOG S1007 (RxPONDER).
Kalinsky K, Barlow W, Pathak H, Gralow J, Albain K, Hayes D, Lin N, Perez E, Goldstein L, Chia S, Rastogi P, Schott A, Shak S, Tripathy D, Hortobagyi G, Meric-Bernstam F, Sharma P, Pusztai L, Thompson A, Godwin A. Correlation of serum anti-Müllerian hormone (AMH) levels on identification of premenopausal patients (pts) with hormone receptor positive (HR+), HER2-negative, node-positive breast cancer most likely to benefit from adjuvant chemotherapy in SWOG S1007 (RxPONDER). Journal Of Clinical Oncology 2024, 42: 505-505. DOI: 10.1200/jco.2024.42.16_suppl.505.Peer-Reviewed Original ResearchInvasive disease-free survivalAnti-Mullerian hormoneFollicular stimulating hormoneAnti-Mullerian hormone levelsPremenopausal patientsRecurrence scoreChemotherapy benefitLuteinizing hormoneHormone levelsInhibin BBreast cancerBenefit of endocrine therapyNode-positive breast cancerPhase 3 randomized trialFluorescent bead-based immunoassayDisease-free survivalInvasive breast cancerNormal ovarian reserveSelf-reported menopausal statusSerum anti-Mullerian hormoneBaseline serum samplesSelection of patientsSerum hormone levelsBaseline hormone levelsUniversity of Kansas Medical Center
2023
Radiotherapy Use and Incidence of Locoregional Recurrence in Patients With Favorable-Risk, Node-Positive Breast Cancer Enrolled in the SWOG S1007 Trial
Jagsi R, Barlow W, Woodward W, Connolly E, Mahtani R, Shumway D, Speers C, Stecklein S, Zeidan Y, Zhang H, Sharma P, Pusztai L, Hortobagyi G, Kalinsky K. Radiotherapy Use and Incidence of Locoregional Recurrence in Patients With Favorable-Risk, Node-Positive Breast Cancer Enrolled in the SWOG S1007 Trial. JAMA Oncology 2023, 9: 1083-1089. PMID: 37410451, PMCID: PMC10326730, DOI: 10.1001/jamaoncol.2023.1984.Peer-Reviewed Original ResearchConceptsInvasive disease-free survivalDisease-free survivalLocoregional recurrenceBreast-conserving surgeryBreast cancerLocoregional therapyCumulative incidenceRecurrence scoreRadiotherapy informationERBB2-negative breast cancerPredictors of LRRRate of LRRSecondary analysisNode-positive breast cancerBreast Recurrence ScoreLimited nodal diseaseLower locoregional recurrenceOmission of chemotherapyAxillary surgeryRadiotherapy receiptEndocrine therapyN1 diseaseNodal diseaseLocoregional treatmentMenopausal statusOncotype DX results increase concordance in adjuvant chemotherapy recommendations for early-stage breast cancer
Licata L, Viale G, Giuliano M, Curigliano G, Chavez-MacGregor M, Foldi J, Oke O, Collins J, Del Mastro L, Puglisi F, Montemurro F, Vernieri C, Gerratana L, Giordano S, Rognone A, Sica L, Gentilini O, Cascinu S, Pusztai L, Giordano A, Criscitiello C, Bianchini G. Oncotype DX results increase concordance in adjuvant chemotherapy recommendations for early-stage breast cancer. Npj Breast Cancer 2023, 9: 51. PMID: 37291235, PMCID: PMC10250312, DOI: 10.1038/s41523-023-00559-6.Peer-Reviewed Original ResearchEarly-stage breast cancerAdjuvant chemotherapy recommendationsChemotherapy recommendationsOncotype DX resultsClinicopathologic featuresRecurrence scorePhysician uncertaintyBreast cancerDiscordant recommendationsAdjuvant chemotherapy resultsAddition of chemotherapyChemotherapy resultsOncotype DXInstitutional databasePhysician judgmentBreast oncologistsClinical practiceOncologistsCancerAssay resultsRS resultsChange recommendationsPredictive informationChemotherapyRecommendationsEvaluation of the Sensitivity to Endocrine Therapy Index and 21-Gene Breast Recurrence Score in the SWOG S8814 Trial
Speers C, Symmans W, Barlow W, Trevarton A, The S, Du L, Rae J, Shak S, Baehner R, Sharma P, Pusztai L, Hortobagyi G, Hayes D, Albain K, Godwin A, Thompson A. Evaluation of the Sensitivity to Endocrine Therapy Index and 21-Gene Breast Recurrence Score in the SWOG S8814 Trial. Journal Of Clinical Oncology 2023, 41: 1841-1848. PMID: 36649570, PMCID: PMC10082279, DOI: 10.1200/jco.22.01499.Peer-Reviewed Original ResearchConceptsBreast Recurrence ScoreAnthracycline-based chemotherapyDisease-free survivalRecurrence scoreEndocrine therapyTherapy indexAdjuvant anthracycline-based chemotherapyNode-positive breast cancerAdjuvant endocrine therapyPrimary end pointSubset of patientsPostmenopausal patientsChemotherapy benefitTreatment armsPrognostic indexPrognostic informationBreast cancerPrognostic assessmentPrognostic performancePatientsEnd pointTumor samplesChemotherapyClinical validationProportional hazards assumption
2022
Expanding the Staging Criteria for T1-2N0 Hormone-Receptor Positive Breast Cancer Patients Enrolled in TAILORx
Kantor O, Burstein HJ, King TA, Shak S, Russell CA, Giuliano AE, Hortobagyi GN, Winer EP, Korde LA, Sparano JA, Mittendorf EA. Expanding the Staging Criteria for T1-2N0 Hormone-Receptor Positive Breast Cancer Patients Enrolled in TAILORx. Annals Of Surgical Oncology 2022, 29: 8016-8023. PMID: 35900648, DOI: 10.1245/s10434-022-12225-5.Peer-Reviewed Original ResearchConceptsRecurrence-free intervalBreast cancer patientsRecurrence scoreTAILORx trialEndocrine therapyCancer patientsHormone receptor-positive breast cancer patientsBackgroundThe American Joint CommitteePositive breast cancer patientsCurrent AJCC staging systemHuman epidermal growth factor receptorBreast Recurrence ScoreKaplan-Meier methodAmerican Joint CommitteeAJCC staging systemEpidermal growth factor receptorGrowth factor receptorMedian followT1-2N0T3 diseasePrognostic stagingStaging systemStaging criteriaBreast cancerResultsThe study
2021
21-Gene Assay to Inform Chemotherapy Benefit in Node-Positive Breast Cancer
Kalinsky K, Barlow WE, Gralow JR, Meric-Bernstam F, Albain KS, Hayes DF, Lin NU, Perez EA, Goldstein LJ, Chia SKL, Dhesy-Thind S, Rastogi P, Alba E, Delaloge S, Martin M, Kelly CM, Ruiz-Borrego M, Gil-Gil M, Arce-Salinas CH, Brain EGC, Lee ES, Pierga JY, Bermejo B, Ramos-Vazquez M, Jung KH, Ferrero JM, Schott AF, Shak S, Sharma P, Lew DL, Miao J, Tripathy D, Pusztai L, Hortobagyi GN. 21-Gene Assay to Inform Chemotherapy Benefit in Node-Positive Breast Cancer. New England Journal Of Medicine 2021, 385: 2336-2347. PMID: 34914339, PMCID: PMC9096864, DOI: 10.1056/nejmoa2108873.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Agents, HormonalAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsChemotherapy, AdjuvantDisease-Free SurvivalFemaleGene Expression ProfilingHumansLymphatic MetastasisMiddle AgedNeoplasm Recurrence, LocalPostmenopausePremenopauseProspective StudiesReceptor, ErbB-2Receptors, SteroidReverse Transcriptase Polymerase Chain ReactionConceptsInvasive disease-free survivalDistant relapse-free survivalDisease-free survivalRelapse-free survivalChemotherapy benefitRecurrence scoreBreast cancerChemoendocrine therapyAdjuvant chemotherapyPostmenopausal womenPremenopausal womenLymph nodesAxillary lymph node-negative breast cancerLymph node-negative breast cancerPositive axillary lymph nodesHER2-negative breast cancerNode-positive breast cancerHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Positive lymph node diseasePositive lymph nodesSecondary end pointsAxillary lymph nodesLymph node diseaseGrowth factor receptor 2Twenty-one-gene recurrence score (RS) in germline (g)CHEK2 mutation-associated versus sporadic breast cancers (BC): A multi-site case-control study.
Afghahi A, Marsh S, Winchester A, Gao D, Parris H, Axell L, Ellisen L, Hofstatter E, Kurian A, Wood M, Zakalik D, Mullin C, Caswell-Jin J, Borges V, Tung N. Twenty-one-gene recurrence score (RS) in germline (g)CHEK2 mutation-associated versus sporadic breast cancers (BC): A multi-site case-control study. Journal Of Clinical Oncology 2021, 39: 10531-10531. DOI: 10.1200/jco.2021.39.15_suppl.10531.Peer-Reviewed Original ResearchCHEK2 pathogenic variantsRecurrence scoreCase-control studyMedian RSBreast cancerPathogenic variantsHigh riskRisk groupsMutation statusHER2-negative BC patientsPR-negative breast cancerMulti-site case-control studyPatient-level clinical dataRS risk groupsLymph node statusHigh recurrence scoreLow-risk groupGermline pathogenic variantsSporadic breast cancerGenetic testing resultsElectronic medical recordsAdjuvant therapyChemotherapy benefitNode statusT stageUtility of the 21-Gene Recurrence Score in Node-Positive Breast Cancer.
Laws A, Garrido-Castro A, Poorvu P, Winer E, Mittendorf E, King T. Utility of the 21-Gene Recurrence Score in Node-Positive Breast Cancer. Oncology 2021, 35: 77-84. PMID: 33577165, DOI: 10.46883/onc.2021.3502.0077.Peer-Reviewed Original ResearchConceptsRecurrence scorePositive nodesClinical trialsBreast cancerHER2-negative breast cancerNode-positive breast cancerLarge population-based registryNode-positive populationAdjuvant chemotherapy useChemotherapy-treated patientsClinical practice guidelinesCurrent practice patternsPopulation-based registryMultiple clinical trialsPotential predictive valueADAPT trialAdjuvant chemotherapyChemotherapy useEndocrine therapyPostmenopausal patientsChemotherapy benefitExcellent outcomesPractice patternsPractice guidelinesRetrospective analysis
2020
Response to neoadjuvant chemotherapy and the 21-gene Breast Recurrence Score test in young women with estrogen receptor-positive early breast cancer
Sella T, Gelber SI, Poorvu PD, Kim HJ, Dominici L, Guzman-Arocho YD, Collins L, Ruddy KJ, Tamimi RM, Peppercorn JM, Schapira L, Borges VF, Come SE, Warner E, Snow C, Jakubowski DM, Russell CA, Winer EP, Rosenberg SM, Partridge AH. Response to neoadjuvant chemotherapy and the 21-gene Breast Recurrence Score test in young women with estrogen receptor-positive early breast cancer. Breast Cancer Research And Treatment 2020, 186: 157-165. PMID: 33150547, DOI: 10.1007/s10549-020-05989-5.Peer-Reviewed Original ResearchConceptsRecurrence Score resultsNeoadjuvant chemotherapyPathological complete responseBreast cancerBreast Cancer StudyYoung womenEstrogen receptor-positive early breast cancerReceptor-positive early breast cancerYoung Women's Breast Cancer StudyHER2-negative breast cancerScore resultsEarly breast cancerLogistic regression modelingAdjuvant chemotherapyNeoadjuvant therapyProspective cohortComplete responseMedian ageMultivariable analysisRecurrence scoreVs. 5Clinical careTumor specimensStage IPatientsOncotype DX testing in node-positive breast cancer strongly impacts chemotherapy use at a comprehensive cancer center
Losk K, Freedman RA, Laws A, Kantor O, Mittendorf EA, Tan-Wasielewski Z, Trippa L, Lin NU, Winer EP, King TA. Oncotype DX testing in node-positive breast cancer strongly impacts chemotherapy use at a comprehensive cancer center. Breast Cancer Research And Treatment 2020, 185: 215-227. PMID: 32939592, DOI: 10.1007/s10549-020-05931-9.Peer-Reviewed Original ResearchConceptsRecurrence-free survivalPN1 breast cancerRecurrence scoreChemotherapy useBreast cancerOverall survivalChemotherapy receiptPN1 patientsRS testingUse of RSNode-positive breast cancerOncotype DX recurrence scoreAdjuvant chemotherapy receiptLow genomic riskNode-positive diseaseAdjuvant treatment decisionsLow recurrence scoreShort-term outcomesMultivariate logistic regressionComprehensive cancer centerDX recurrence scoreOncotype DX testingChemotherapy omissionPT1-2N0Upfront surgeryAssociation of 21-Gene Assay (OncotypeDX) Testing and Receipt of Chemotherapy in the Medicare Breast Cancer Patient Population Following Initial Adoption
Dinan MA, Wilson LE, Reed SD, Griggs JJ, Norton EC. Association of 21-Gene Assay (OncotypeDX) Testing and Receipt of Chemotherapy in the Medicare Breast Cancer Patient Population Following Initial Adoption. Clinical Breast Cancer 2020, 20: 487-494.e1. PMID: 32653473, DOI: 10.1016/j.clbc.2020.05.010.Peer-Reviewed Original ResearchResponse to neoadjuvant chemotherapy and the 21-gene breast recurrence score in young women with estrogen receptor-positive early breast cancer.
Sella T, Gelber S, Poorvu P, Kim H, Guzman Arocho Y, Collins L, Ruddy K, Tamimi R, Peppercorn J, Schapira L, Borges V, Come S, Warner E, Snow C, Jakubowski D, Russell C, Winer E, Rosenberg S, Partridge A. Response to neoadjuvant chemotherapy and the 21-gene breast recurrence score in young women with estrogen receptor-positive early breast cancer. Journal Of Clinical Oncology 2020, 38: 514-514. DOI: 10.1200/jco.2020.38.15_suppl.514.Peer-Reviewed Original ResearchPathologic complete responseBreast Recurrence ScoreNeoadjuvant chemotherapyBreast cancerRecurrence scoreBreast Cancer StudyYoung womenHER2- BCEstrogen receptor-positive early breast cancerHER-2 negative breast cancerReceptor-positive early breast cancerYoung Women's Breast Cancer StudyNeoadjuvant endocrine therapyResidual invasive tumorEarly breast cancerPost-menopausal womenNegative breast cancerHigh gradeLogistic regression modelingAdjuvant chemotherapyDuctal histologyPgR negativityEndocrine therapyNeoadjuvant therapyProspective cohortExpanding criteria for prognostic stage IA disease in HR+ breast cancer.
Kantor O, King T, Shak S, Russell C, Giuliano A, Hortobagyi G, Burstein H, Winer E, Sparano J, Mittendorf E. Expanding criteria for prognostic stage IA disease in HR+ breast cancer. Journal Of Clinical Oncology 2020, 38: 550-550. DOI: 10.1200/jco.2020.38.15_suppl.550.Peer-Reviewed Original ResearchStage IA diseaseRecurrence scoreIA diseaseN categoryOncotype DX recurrence scoreNode-positive diseaseAJCC staging systemDX recurrence scoreRS resultsRS 11Median followDSS ratesPositive diseaseSEER databaseReceptor statusStaging systemEvidence of utilityScore 11Breast cancerTrial dataDiseaseAdditional studiesPatientsStagingDSS
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