2024
Pathologic complete response (pCR) rates for patients with HR+/HER2- high-risk, early-stage breast cancer (EBC) by clinical and molecular features in the phase II I-SPY2 clinical trial
Huppert L, Wolf D, Yau C, Brown-Swigart L, Hirst G, Isaacs C, Pusztai L, Pohlmann P, DeMichele A, Shatsky R, Yee D, Thomas A, Nanda R, Perlmutter J, Heditsian D, Hylton N, Symmans F, Veer L, Esserman L, Rugo H. Pathologic complete response (pCR) rates for patients with HR+/HER2- high-risk, early-stage breast cancer (EBC) by clinical and molecular features in the phase II I-SPY2 clinical trial. Annals Of Oncology 2024 PMID: 39477071, DOI: 10.1016/j.annonc.2024.10.018.Peer-Reviewed Original ResearchDistant recurrence-free survivalEarly-stage breast cancerPathological complete responsePathologic complete response rateClinical/molecular featuresComplete responseER-positiveBreast cancerRate of pathological complete responseResponse to neoadjuvant chemotherapyRecurrence-free survivalI-SPY2 trialOptimal treatment selectionNeoadjuvant armER/PR statusLobular histologyNeoadjuvant chemotherapyIII diseaseImmune signaturesNegative diseaseOptimal therapyI-SPY2Excellent outcomesTreatment armsFollow-up
2023
Race, Gene Expression Signatures, and Clinical Outcomes of Patients With High-Risk Early Breast Cancer
Kyalwazi B, Yau C, Campbell M, Yoshimatsu T, Chien A, Wallace A, Forero-Torres A, Pusztai L, Ellis E, Albain K, Blaes A, Haley B, Boughey J, Elias A, Clark A, Isaacs C, Nanda R, Han H, Yung R, Tripathy D, Edmiston K, Viscusi R, Northfelt D, Khan Q, Asare S, Wilson A, Hirst G, Lu R, Symmans W, Yee D, DeMichele A, van ’t Veer L, Esserman L, Olopade O. Race, Gene Expression Signatures, and Clinical Outcomes of Patients With High-Risk Early Breast Cancer. JAMA Network Open 2023, 6: e2349646. PMID: 38153734, PMCID: PMC10755617, DOI: 10.1001/jamanetworkopen.2023.49646.Peer-Reviewed Original ResearchConceptsDistant recurrence-free survivalPathologic complete responseErbB2-negative tumorsWorse distant recurrence-free survivalEarly breast cancerWhite patientsBreast cancerBlack patientsGene expression signaturesReceptor subtypesStage II/III breast cancerHigh-risk early breast cancerCox proportional hazards regression modelHigh-risk breast cancerClinical trial end pointsProportional hazards regression modelsTumor receptor subtypeRetrospective cohort studyPrimary tumor sizeRecurrence-free survivalTrial end pointsBreast cancer outcomesLong-term outcomesHazards regression modelsExpression signaturesCorrelation of HER2 low status in I-SPY2 with molecular subtype, response, and survival.
Rugo H, Wolf D, Yau C, Petricoin E, Pohlmann P, Pusztai L, Symmans W, Borowsky A, Finestone S, Yee D, Hylton N, van 't Veer L, Esserman L, DeMichele A. Correlation of HER2 low status in I-SPY2 with molecular subtype, response, and survival. Journal Of Clinical Oncology 2023, 41: 514-514. DOI: 10.1200/jco.2023.41.16_suppl.514.Peer-Reviewed Original ResearchDistant recurrence-free survivalPathologic complete responseBreast cancerFisher's exact testExact testMolecular subtypesHER2-negative breast cancerHigh-risk breast cancerRisk breast cancerMetastatic breast cancerRecurrence-free survivalTN breast cancerRecurrence-free survival dataCox proportional hazardsHER2 gene amplificationI-SPY2TN diseaseFree survivalOverall survivalComplete responseHazard ratioTrastuzumab deruxtecanEndocrine sensitivityT-DXdTreatment arms
2020
Association of Event-Free and Distant Recurrence–Free Survival With Individual-Level Pathologic Complete Response in Neoadjuvant Treatment of Stages 2 and 3 Breast Cancer
Consortium I, Yee D, DeMichele A, Yau C, Isaacs C, Symmans W, Albain K, Chen Y, Krings G, Wei S, Harada S, Datnow B, Fadare O, Klein M, Pambuccian S, Chen B, Adamson K, Sams S, Mhawech-Fauceglia P, Magliocco A, Feldman M, Rendi M, Sattar H, Zeck J, Ocal I, Tawfik O, LeBeau L, Sahoo S, Vinh T, Chien A, Forero-Torres A, Stringer-Reasor E, Wallace A, Pusztai L, Boughey J, Ellis E, Elias A, Lu J, Lang J, Han H, Clark A, Nanda R, Northfelt D, Khan Q, Viscusi R, Euhus D, Edmiston K, Chui S, Kemmer K, Park J, Liu M, Olopade O, Leyland-Jones B, Tripathy D, Moulder S, Rugo H, Schwab R, Lo S, Helsten T, Beckwith H, Haugen P, Hylton N, Veer L, Perlmutter J, Melisko M, Wilson A, Peterson G, Asare A, Buxton M, Paoloni M, Clennell J, Hirst G, Singhrao R, Steeg K, Matthews J, Asare S, Sanil A, Berry S, Esserman L, Berry D. Association of Event-Free and Distant Recurrence–Free Survival With Individual-Level Pathologic Complete Response in Neoadjuvant Treatment of Stages 2 and 3 Breast Cancer. JAMA Oncology 2020, 6: 1355-1362. PMID: 32701140, PMCID: PMC7378873, DOI: 10.1001/jamaoncol.2020.2535.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsBridged-Ring CompoundsCyclophosphamideDisease-Free SurvivalDoxorubicinFemaleHumansMiddle AgedNeoadjuvant TherapyNeoplasm Recurrence, LocalProgression-Free SurvivalProportional Hazards ModelsReceptor, ErbB-2TaxoidsTrastuzumabTreatment OutcomeConceptsDistant recurrence-free survivalPathologic complete responseEvent-free survivalI-SPY2 trialRecurrence-free survivalLong-term outcomesBreast cancerComplete responseNeoadjuvant therapyPlatform trialsMolecular subtypesHigh-risk operable breast cancerThree-year event-free survivalHormone receptorsClinical stage 2Phase 3 confirmatory trialOperable breast cancerSubpopulation of womenNovel therapeutic combinationsStage 2Investigational regimensNeoadjuvant treatmentPrior surgeryTaxane treatmentStandard therapyEffect of Pembrolizumab Plus Neoadjuvant Chemotherapy on Pathologic Complete Response in Women With Early-Stage Breast Cancer
Nanda R, Liu MC, Yau C, Shatsky R, Pusztai L, Wallace A, Chien AJ, Forero-Torres A, Ellis E, Han H, Clark A, Albain K, Boughey JC, Jaskowiak NT, Elias A, Isaacs C, Kemmer K, Helsten T, Majure M, Stringer-Reasor E, Parker C, Lee MC, Haddad T, Cohen RN, Asare S, Wilson A, Hirst GL, Singhrao R, Steeg K, Asare A, Matthews JB, Berry S, Sanil A, Schwab R, Symmans WF, van ‘t Veer L, Yee D, DeMichele A, Hylton NM, Melisko M, Perlmutter J, Rugo HS, Berry DA, Esserman LJ. Effect of Pembrolizumab Plus Neoadjuvant Chemotherapy on Pathologic Complete Response in Women With Early-Stage Breast Cancer. JAMA Oncology 2020, 6: 676-684. PMID: 32053137, PMCID: PMC7058271, DOI: 10.1001/jamaoncol.2019.6650.Peer-Reviewed Original ResearchConceptsEarly-stage breast cancerPathologic complete responseNeoadjuvant chemotherapyPhase 3 trialResidual cancer burdenStandard neoadjuvant chemotherapyBreast cancerComplete responseInvestigational armStage II/III breast cancerHigher event-free survival rateERBB2-negative breast cancerEvent-free survival rateAnthracycline-based neoadjuvant chemotherapyDistant recurrence-free survivalEnd pointTriple-negative breast cancerCycles of pembrolizumabEffect of pembrolizumabImmune-related endocrinopathiesNeoadjuvant clinical trialsTriple-negative cohortPrimary end pointSecondary end pointsRecurrence-free survival