2023
Adjuvant paclitaxel and trastuzumab for node-negative, HER2-positive breast cancer: final 10-year analysis of the open-label, single-arm, phase 2 APT trial
Tolaney S, Tarantino P, Graham N, Tayob N, Parè L, Villacampa G, Dang C, Yardley D, Moy B, Marcom P, Albain K, Rugo H, Ellis M, Shapira I, Wolff A, Carey L, Barroso-Sousa R, Villagrasa P, DeMeo M, DiLullo M, Zanudo J, Weiss J, Wagle N, Partridge A, Waks A, Hudis C, Krop I, Burstein H, Prat A, Winer E. Adjuvant paclitaxel and trastuzumab for node-negative, HER2-positive breast cancer: final 10-year analysis of the open-label, single-arm, phase 2 APT trial. The Lancet Oncology 2023, 24: 273-285. PMID: 36858723, DOI: 10.1016/s1470-2045(23)00051-7.Peer-Reviewed Original ResearchConceptsHER2-positive breast cancerInvasive disease-free survivalDisease-free survivalRecurrence-free intervalAdjuvant paclitaxelBreast cancerEastern Cooperative Oncology Group performance statusInvasive disease-free survival eventsDisease-free survival eventsHormone receptor-positive diseaseNew contralateral breast cancerBreast cancer-specific survivalProtocol-defined treatmentCancer-specific survivalReceptor-positive diseasePhase 2 studyContralateral breast cancerLong-term outcomesAPT trialCause deathEligible patientsIntravenous paclitaxelTrastuzumab weeklyDistant recurrenceIpsilateral recurrence
2020
Sensitive Detection of Minimal Residual Disease in Patients Treated for Early-Stage Breast Cancer
Parsons HA, Rhoades J, Reed SC, Gydush G, Ram P, Exman P, Xiong K, Lo CC, Li T, Fleharty M, Kirkner GJ, Rotem D, Cohen O, Yu F, Fitarelli-Kiehl M, Leong KW, Hughes ME, Rosenberg SM, Collins LC, Miller KD, Blumenstiel B, Trippa L, Cibulskis C, Neuberg DS, DeFelice M, Freeman SS, Lennon NJ, Wagle N, Ha G, Stover DG, Choudhury AD, Getz G, Winer EP, Meyerson M, Lin NU, Krop I, Love JC, Makrigiorgos GM, Partridge AH, Mayer EL, Golub TR, Adalsteinsson VA. Sensitive Detection of Minimal Residual Disease in Patients Treated for Early-Stage Breast Cancer. Clinical Cancer Research 2020, 26: 2556-2564. PMID: 32170028, PMCID: PMC7654718, DOI: 10.1158/1078-0432.ccr-19-3005.Peer-Reviewed Original ResearchConceptsMinimal residual diseaseMetastatic breast cancerDigital droplet PCRBreast cancerTumor mutationsResidual diseaseMRD detectionEarly-stage breast cancerCurative-intent treatmentCohort of patientsEarly-stage diseaseMedian lead timeClinical data collectionWhole-exome sequencingMRD testFirst positive sampleDistant recurrenceMost patientsMetastatic diagnosisStage 0PatientsPlasma samplingClinical sensitivityPatient-specific mutationsCfDNA samples
2019
Prognostic Impact of the 21-Gene Recurrence Score Assay Among Young Women With Node-Negative and Node-Positive ER-Positive/HER2-Negative Breast Cancer
Poorvu PD, Gelber SI, Rosenberg SM, Ruddy KJ, Tamimi RM, Collins LC, Peppercorn J, Schapira L, Borges VF, Come SE, Warner E, Jakubowski DM, Russell C, Winer EP, Partridge AH. Prognostic Impact of the 21-Gene Recurrence Score Assay Among Young Women With Node-Negative and Node-Positive ER-Positive/HER2-Negative Breast Cancer. Journal Of Clinical Oncology 2019, 38: 725-733. PMID: 31809240, PMCID: PMC7048163, DOI: 10.1200/jco.19.01959.Peer-Reviewed Original ResearchConceptsNode-positive breast cancerDistant recurrence-free survivalRecurrence scoreBreast cancerBreast Cancer StudyN0 diseaseN1 diseaseYoung womenYoung Women's Breast Cancer StudyPositive/HER2-negative breast cancerHER2-negative breast cancerHuman epidermal growth factor receptorEarly distant recurrenceEarly-stage estrogenN0 breast cancerRS risk groupsNode-positive diseaseMinority of patientsRecurrence-free survivalYears of ageEpidermal growth factor receptorGrowth factor receptorDistant recurrenceAxillary nodesEligible women
2018
Unraveling the clinicopathological features driving the emergence of ESR1 mutations in metastatic breast cancer
Kuang Y, Siddiqui B, Hu J, Pun M, Cornwell M, Buchwalter G, Hughes ME, Wagle N, Kirschmeier P, Jänne PA, Paweletz CP, Lin NU, Krop IE, Barry WT, Winer EP, Brown M, Jeselsohn R. Unraveling the clinicopathological features driving the emergence of ESR1 mutations in metastatic breast cancer. Npj Breast Cancer 2018, 4: 22. PMID: 30083595, PMCID: PMC6072793, DOI: 10.1038/s41523-018-0075-5.Peer-Reviewed Original ResearchMetastatic breast cancerESR1 mutationsBreast cancerMetastatic settingClinicopathological featuresPIK3CA mutationsAromatase inhibitorsER-positive metastatic breast cancerDetailed clinical dataSpecific systemic treatmentMetastatic treatmentDistant recurrenceMetastatic diseaseSystemic treatmentPrimary diseaseEndocrine resistanceCDK4/6 inhibitorsPathological featuresFulvestrant treatmentClinical dataPrior treatmentSignificant associationPatientsCancerPrevalenceTailoring Adjuvant Endocrine Therapy for Premenopausal Breast Cancer
Francis PA, Pagani O, Fleming GF, Walley BA, Colleoni M, Láng I, Gómez HL, Tondini C, Ciruelos E, Burstein HJ, Bonnefoi HR, Bellet M, Martino S, Geyer CE, Goetz MP, Stearns V, Pinotti G, Puglisi F, Spazzapan S, Climent MA, Pavesi L, Ruhstaller T, Davidson NE, Coleman R, Debled M, Buchholz S, Ingle JN, Winer EP, Maibach R, Rabaglio-Poretti M, Ruepp B, Di Leo A, Coates AS, Gelber RD, Goldhirsch A, Regan MM. Tailoring Adjuvant Endocrine Therapy for Premenopausal Breast Cancer. New England Journal Of Medicine 2018, 379: 122-137. PMID: 29863451, PMCID: PMC6193457, DOI: 10.1056/nejmoa1803164.Peer-Reviewed Original ResearchConceptsTamoxifen plus ovarian suppressionTamoxifen-alone groupOvarian suppressionPremenopausal womenBreast cancerAdverse eventsOverall survivalDisease-free survival ratesOvarian Function TrialYears of tamoxifenAdjuvant endocrine therapyHigher adverse eventsReceipt of chemotherapyPremenopausal breast cancerLow recurrence rateAromatase inhibitor exemestaneUse of exemestaneSuppression groupExemestane TrialDistant recurrenceEndocrine therapyRecurrence rateGrade 3ExemestaneTamoxifen
2017
Long-term outcomes for neoadjuvant versus adjuvant chemotherapy in early breast cancer: meta-analysis of individual patient data from ten randomised trials
Group E, Asselain B, Barlow W, Bartlett J, Bergh J, Bergsten-Nordström E, Bliss J, Boccardo F, Boddington C, Bogaerts J, Bonadonna G, Bradley R, Brain E, Braybrooke J, Broet P, Bryant J, Burrett J, Cameron D, Clarke M, Coates A, Coleman R, Coombes R, Correa C, Costantino J, Cuzick J, Danforth D, Davidson N, Davies C, Davies L, Di Leo A, Dodwell D, Dowsett M, Duane F, Evans V, Ewertz M, Fisher B, Forbes J, Ford L, Gazet J, Gelber R, Gettins L, Gianni L, Gnant M, Godwin J, Goldhirsch A, Goodwin P, Gray R, Hayes D, Hill C, Ingle J, Jagsi R, Jakesz R, James S, Janni W, Liu H, Liu Z, Lohrisch C, Loibl S, MacKinnon L, Makris A, Mamounas E, Mannu G, Martín M, Mathoulin S, Mauriac L, McGale P, McHugh T, Morris P, Mukai H, Norton L, Ohashi Y, Olivotto I, Paik S, Pan H, Peto R, Piccart M, Pierce L, Poortmans P, Powles T, Pritchard K, Ragaz J, Raina V, Ravdin P, Read S, Regan M, Robertson J, Rutgers E, Scholl S, Slamon D, Sölkner L, Sparano J, Steinberg S, Sutcliffe R, Swain S, Taylor C, Tutt A, Valagussa P, van de Velde C, van der Hage J, Viale G, von Minckwitz G, Wang Y, Wang Z, Wang X, Whelan T, Wilcken N, Winer E, Wolmark N, Wood W, Zambetti M, Zujewski J. Long-term outcomes for neoadjuvant versus adjuvant chemotherapy in early breast cancer: meta-analysis of individual patient data from ten randomised trials. The Lancet Oncology 2017, 19: 27-39. PMID: 29242041, PMCID: PMC5757427, DOI: 10.1016/s1470-2045(17)30777-5.Peer-Reviewed Original ResearchConceptsBreast-conserving therapyEarly breast cancerNeoadjuvant chemotherapyAdjuvant chemotherapyIndividual patient dataLocal recurrenceBreast cancerSame chemotherapyDistant recurrenceTumor characteristicsTumor responsePartial clinical responseYear local recurrencePatient dataBreast cancer deathsHigher local recurrenceBreast-conserving surgeryClinical tumor responseUK Medical Research CouncilBreast cancer mortalityLong-term outcomesFrequent local recurrenceLog-rank methodBritish Heart FoundationThird of womenSeven-year (yr) follow-up of adjuvant paclitaxel (T) and trastuzumab (H) (APT trial) for node-negative, HER2-positive breast cancer (BC).
Tolaney S, Barry W, Guo H, Dillon D, Dang C, Yardley D, Moy B, Marcom P, Albain K, Rugo H, Ellis M, Shapira I, Wolff A, Carey L, Overmoyer B, Partridge A, Hudis C, Krop I, Burstein H, Winer E. Seven-year (yr) follow-up of adjuvant paclitaxel (T) and trastuzumab (H) (APT trial) for node-negative, HER2-positive breast cancer (BC). Journal Of Clinical Oncology 2017, 35: 511-511. DOI: 10.1200/jco.2017.35.15_suppl.511.Peer-Reviewed Original ResearchBreast cancer-specific survivalDisease-free survivalRecurrence-free intervalBreast cancerDistant recurrenceOverall survivalTumor sizeNew contralateral breast cancerHER2-positive breast cancerNode-negative HER2Cancer-specific survivalPhase II studyContralateral breast cancerAdjuvant paclitaxelAPT trialNodal micrometastasisPrimary endpointProtocol therapyAdjuvant therapyDFS eventsII studyDisease recurrenceRegional recurrenceSpecific survivalClinical outcomes
2016
Adjuvant Endocrine Therapy for Women With Hormone Receptor–Positive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update on Ovarian Suppression
Burstein HJ, Lacchetti C, Anderson H, Buchholz TA, Davidson NE, Gelmon KE, Giordano SH, Hudis CA, Solky AJ, Stearns V, Winer EP, Griggs JJ. Adjuvant Endocrine Therapy for Women With Hormone Receptor–Positive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update on Ovarian Suppression. Journal Of Clinical Oncology 2016, 34: 1689-1701. PMID: 26884586, DOI: 10.1200/jco.2015.65.9573.Peer-Reviewed Original ResearchConceptsReceptor-positive breast cancerAdjuvant endocrine therapyOvarian suppressionStandard adjuvant therapyEndocrine therapyBreast cancerAdjuvant chemotherapyAdjuvant therapyAromatase inhibitorsClinical Oncology Clinical Practice Guideline UpdateHormone receptor-positive breast cancerEstrogen receptor-positive breast cancerClinical Practice Guideline UpdateStage I breast cancerDisease-free survivalHigh-risk patientsLow-risk patientsI breast cancerSubset of patientsOverall clinical benefitRandomized clinical trialsNode-negative cancersQuality of lifeDistant recurrencePremenopausal womenPAM50 gene signatures and breast cancer prognosis with adjuvant anthracycline- and taxane-based chemotherapy: correlative analysis of C9741 (Alliance)
Liu MC, Pitcher BN, Mardis ER, Davies SR, Friedman PN, Snider JE, Vickery TL, Reed JP, DeSchryver K, Singh B, Gradishar WJ, Perez EA, Martino S, Citron ML, Norton L, Winer EP, Hudis CA, Carey LA, Bernard PS, Nielsen TO, Perou CM, Ellis MJ, Barry WT. PAM50 gene signatures and breast cancer prognosis with adjuvant anthracycline- and taxane-based chemotherapy: correlative analysis of C9741 (Alliance). Npj Breast Cancer 2016, 2: 15023. PMID: 28691057, PMCID: PMC5501351, DOI: 10.1038/npjbcancer.2015.23.Peer-Reviewed Original ResearchIntrinsic subtypesOverall survivalGene signaturePAM50 gene signatureCox proportional hazards modelIntrinsic breast cancer subtypesPAM50 intrinsic subtypesStandard clinicopathologic factorsMultivariable Cox modelTaxane-based chemotherapyTaxane-based therapyEvaluable subsetProportional hazards modelBreast cancer subtypesBreast cancer prognosisClinical validation studyAdjuvant anthracyclinesCALGB 9741Distant recurrenceClinicopathologic factorsPrognostic valueRecurrence scoreImproved outcomesTreatment benefitClinical covariates
2008
Sites of distant recurrence and clinical outcomes in patients with metastatic triple‐negative breast cancer
Lin NU, Claus E, Sohl J, Razzak AR, Arnaout A, Winer EP. Sites of distant recurrence and clinical outcomes in patients with metastatic triple‐negative breast cancer. Cancer 2008, 113: 2638-2645. PMID: 18833576, PMCID: PMC2835546, DOI: 10.1002/cncr.23930.Peer-Reviewed Original ResearchConceptsMetastatic triple-negative breast cancerTriple-negative breast cancerBreast cancerCNS metastasesMedian survivalMetastatic diagnosisSystemic diseaseCentral nervous system recurrenceDana-Farber Cancer InstituteInitial metastatic diagnosisProgressive CNS diseaseOutcomes of patientsNew treatment strategiesRace-adjusted ratesCNS progressionBrain metastasesCNS involvementCNS recurrenceDistant recurrenceMetastatic presentationCNS lesionsClinical outcomesPathology recordsCNS diseaseAggressive subtypeTen-Year Survival and Cost Following Breast Cancer Recurrence: Estimates from SEER-Medicare Data
Stokes ME, Thompson D, Montoya EL, Weinstein MC, Winer EP, Earle CC. Ten-Year Survival and Cost Following Breast Cancer Recurrence: Estimates from SEER-Medicare Data. Value In Health 2008, 11: 213-220. PMID: 18380633, DOI: 10.1111/j.1524-4733.2007.00226.x.Peer-Reviewed Original ResearchConceptsBreast cancer recurrenceBreast cancer eventsContralateral breast cancerNonmetastatic breast cancerSEER-Medicare dataBreast cancerCancer recurrenceDistant recurrenceSurveillance EpidemiologyCancer eventsMedicare claimsNational Cancer Institute's Surveillance EpidemiologyBreast cancer leadEnd Results registryTen-year survivalImpact of recurrencePaucity of dataMedian survivalPharmacologic therapyLocal recurrenceRetrospective analysisRecurrencePatientsCancer leadCancer