2024
Development 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, jco2401507. PMID: 39621968, 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 dataDevelopment 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 modelRecurrence 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 raceNHBHER2Correlation 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
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 2
2017
Impacts of Early Guideline-Directed 21-Gene Recurrence Score Testing on Adjuvant Therapy Decision Making
Dzimitrowicz H, Mougalian S, Storms S, Hurd S, Chagpar AB, Killelea BK, Horowitz NR, Lannin DR, Harigopal M, Hofstatter E, DiGiovanna MP, Adelson KB, Silber A, Abu-Khalaf M, Chung G, Zaheer W, Abdelghany O, Hatzis C, Pusztai L, Sanft TB. Impacts of Early Guideline-Directed 21-Gene Recurrence Score Testing on Adjuvant Therapy Decision Making. JCO Oncology Practice 2017, 13: jop.2017.022731. PMID: 29048991, DOI: 10.1200/jop.2017.022731.Peer-Reviewed Original ResearchConceptsAdjuvant therapy decisionsRecurrence scoreChemotherapy useRS testingMedical oncologistsHistorical controlsChemotherapy decisionsTherapy decisionsEligibility criteriaNational Comprehensive Cancer Network guidelinesProspective quality improvement projectEarly-stage breast cancerAdjuvant chemotherapy recommendationsTime of diagnosisTime of surgeryQuality improvement projectTesting groupChemotherapy initiationChemotherapy recommendationsMedian timeTrial enrollmentNetwork guidelinesSurgical oncologistsClinical trialsBreast cancer
2015
The 21-gene recurrence score complements IBTR! Estimates in early-stage, hormone receptor-positive, HER2-normal, lymph node-negative breast cancer
Thaker NG, Hoffman KE, Stauder MC, Shaitelman SF, Strom EA, Tereffe W, Smith BD, Perkins GH, Huo L, Munsell MF, Pusztai L, Buchholz TA, Woodward WA. The 21-gene recurrence score complements IBTR! Estimates in early-stage, hormone receptor-positive, HER2-normal, lymph node-negative breast cancer. SpringerPlus 2015, 4: 36. PMID: 25674496, PMCID: PMC4318826, DOI: 10.1186/s40064-015-0840-y.Peer-Reviewed Original ResearchIpsilateral breast tumor recurrenceRecurrence scoreBreast cancerRisk of IBTRGrade I/II diseaseLymph node-negative breast cancerNode-negative breast cancerStage I/IIRisk of LRBreast tumor recurrenceLocoregional recurrence riskKi-67 expressionIndividualized treatment decisionsLow event ratesIBTR rateMost patientsConsecutive patientsMedian ageRS testingProspective studyRetrospective studyTumor recurrenceTreatment decisionsRadiation therapyRecurrence risk
2013
Complementing Ipsilateral Breast Tumor Recurrence (IBTR!) Estimates With the 21-Gene Recurrence Score (RS) in Early-Stage, Hormone Receptor-Positive, HER2-Normal, Lymph Node-Negative Breast Cancers
Thaker N, Hoffman K, Pusztai L, Buchholz T, Woodward W. Complementing Ipsilateral Breast Tumor Recurrence (IBTR!) Estimates With the 21-Gene Recurrence Score (RS) in Early-Stage, Hormone Receptor-Positive, HER2-Normal, Lymph Node-Negative Breast Cancers. International Journal Of Radiation Oncology • Biology • Physics 2013, 87: s100-s101. DOI: 10.1016/j.ijrobp.2013.06.260.Peer-Reviewed Original ResearchA comparative analysis of distant recurrence risk assessments by Oncotype DX recurrence score alone and integrated with clinicopathologic factors in early-stage breast cancer.
Kelly C, Beamish R, McCaffrey J, SMITH M, Crown J, O'Connor M, McGee S, O'Reilly S, Moylan E, Gonzalez-Angulo A, Litton J, Pusztai L, Kelly C. A comparative analysis of distant recurrence risk assessments by Oncotype DX recurrence score alone and integrated with clinicopathologic factors in early-stage breast cancer. Journal Of Clinical Oncology 2013, 31: 598-598. DOI: 10.1200/jco.2013.31.15_suppl.598.Peer-Reviewed Original ResearchRisk of recurrenceOncotype DX recurrence scoreRecurrence scoreDX recurrence scoreClinicopathologic factorsBreast cancerRecurrence risk assessmentDistant recurrenceNode negativeIR groupOncotype DXRisk groupsHER-2 negative breast cancerHER2-negative breast cancerEarly-stage breast cancerProportion of patientsOncotype DX testingNegative breast cancerChemotherapy benefitNodal statusPatient chartsTumor sizeClinical trialsAcademic hospitalLR group
2012
Assessment of method of breast cancer detection and Onco type DX recurrence score.
Kelly C, Parker I, McCaffrey J, Crown J, O'Connor M, McGee S, Pusztai L, Kelly C. Assessment of method of breast cancer detection and Onco type DX recurrence score. Journal Of Clinical Oncology 2012, 30: 581-581. DOI: 10.1200/jco.2012.30.15_suppl.581.Peer-Reviewed Original ResearchRecurrence scoreClinicopathological variablesBreast cancerLymph nodesHER-2 negative breast cancerSignificant associationHER2-negative breast cancerFavorable pathological characteristicsTraditional clinicopathological variablesScreen-detected cancersNumber of patientsDX recurrence scoreNegative breast cancerMethod of detectionOncotypeDX recurrence scoreLymphovascular invasionBetter prognosisInterval cancersPatient chartsRoutine careTumor sizePathological characteristicsPrognostic informationTumor gradeClinical trials
2010
Utility of oncotype DX risk estimates in clinically intermediate risk hormone receptor‐positive, HER2‐normal, grade II, lymph node‐negative breast cancers
Kelly CM, Krishnamurthy S, Bianchini G, Litton JK, Gonzalez‐Angulo A, Hortobagyi GN, Pusztai L. Utility of oncotype DX risk estimates in clinically intermediate risk hormone receptor‐positive, HER2‐normal, grade II, lymph node‐negative breast cancers. Cancer 2010, 116: 5161-5167. PMID: 20665886, DOI: 10.1002/cncr.25269.Peer-Reviewed Original ResearchConceptsTrial Assigning Individualized OptionsRisk of recurrenceOncotype DXRecurrence scoreBreast cancerIntermediate riskGrade I/II tumorsLymph node-negative breast cancerNode-negative breast cancerStage I/IID. Anderson Cancer CenterOncotype DX breast cancerRisk estimatesIntermediate-risk populationEarly breast cancerRoutine clinical variablesHigh-risk groupOncotype DX testingAnderson Cancer CenterAdjuvant chemotherapyDistant recurrenceConsecutive patientsII tumorsClinicopathological variablesLobular carcinoma
2005
Gene Expression Profiles in Paraffin-Embedded Core Biopsy Tissue Predict Response to Chemotherapy in Women With Locally Advanced Breast Cancer
Gianni L, Zambetti M, Clark K, Baker J, Cronin M, Wu J, Mariani G, Rodriguez J, Carcangiu M, Watson D, Valagussa P, Rouzier R, Symmans WF, Ross JS, Hortobagyi GN, Pusztai L, Shak S. Gene Expression Profiles in Paraffin-Embedded Core Biopsy Tissue Predict Response to Chemotherapy in Women With Locally Advanced Breast Cancer. Journal Of Clinical Oncology 2005, 23: 7265-7277. PMID: 16145055, DOI: 10.1200/jco.2005.02.0818.Peer-Reviewed Original ResearchConceptsPathologic complete responseAdvanced breast cancerBreast cancerNeoadjuvant paclitaxelRecurrence scoreChemotherapy responseRecurrence riskLikelihood of pCRGreater recurrence riskReverse transcriptase-polymerase chain reactionTranscriptase-polymerase chain reactionCore biopsy tissueImmune-related genesNeoadjuvant anthracyclineNeoadjuvant studiesAssessable patientsReceptor-related genesChemotherapy benefitComplete responseCore biopsyPolymerase chain reactionUnivariate analysisProliferation-related genesIndependent patientsBiopsy tissue