2022
Overall Survival with Ribociclib plus Letrozole in Advanced Breast Cancer
Hortobagyi GN, Stemmer SM, Burris HA, Yap YS, Sonke GS, Hart L, Campone M, Petrakova K, Winer EP, Janni W, Conte P, Cameron DA, André F, Arteaga CL, Zarate JP, Chakravartty A, Taran T, Le Gac F, Serra P, O'Shaughnessy J. Overall Survival with Ribociclib plus Letrozole in Advanced Breast Cancer. New England Journal Of Medicine 2022, 386: 942-950. PMID: 35263519, DOI: 10.1056/nejmoa2114663.Peer-Reviewed Original ResearchConceptsAdvanced breast cancerSignificant overall survival benefitMedian overall survivalOverall survival benefitProgression-free survivalOverall survivalBreast cancerSurvival benefitHER2-negative advanced breast cancerKey secondary end pointProtocol-specified final analysisLonger progression-free survivalHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Negative advanced breast cancerStratified log-rank testFirst-line ribociclibSecondary end pointsFirst-line therapyNew safety signalsPhase 3 trialGrowth factor receptor 2Kaplan-Meier methodLog-rank testFactor receptor 2
2018
Mixed Invasive Ductal and Lobular Carcinoma of the Breast: Prognosis and the Importance of Histologic Grade
Metzger‐Filho O, Ferreira AR, Jeselsohn R, Barry WT, Dillon DA, Brock JE, Vaz‐Luis I, Hughes ME, Winer EP, Lin NU. Mixed Invasive Ductal and Lobular Carcinoma of the Breast: Prognosis and the Importance of Histologic Grade. The Oncologist 2018, 24: e441-e449. PMID: 30518616, PMCID: PMC6656459, DOI: 10.1634/theoncologist.2018-0363.Peer-Reviewed Original ResearchMeSH KeywordsCarcinoma, Ductal, BreastCarcinoma, LobularFemaleHumansMiddle AgedNeoplasm GradingPrognosisRetrospective StudiesSurvival RateConceptsInvasive lobular carcinomaDisease-free survivalHistologic gradeLobular carcinomaPostmenopausal womenSystemic therapyBetter prognosisAromatase inhibitorsPrognostic powerDisease-free survival advantageEarly-stage breast cancerFavorable disease-free survivalCox proportional hazards modelAdjuvant aromatase inhibitorsBaseline clinicopathologic characteristicsDetailed clinical databaseHER2-negative diseaseRetrospective cohort studyImportant prognostic factorKaplan-Meier methodProportional hazards modelIntermediate histologic gradeDistinct disease subtypesCohort studyOverall prognosis
2017
Patterns of Utilization of Imaging Studies and Serum Tumor Markers Among Patients With De Novo Metastatic Breast Cancer.
Di Meglio A, Lin NU, Freedman RA, Barry WT, Winer EP, Vaz-Luis I. Patterns of Utilization of Imaging Studies and Serum Tumor Markers Among Patients With De Novo Metastatic Breast Cancer. Journal Of The National Comprehensive Cancer Network 2017, 15: 316-324. PMID: 28275032, DOI: 10.6004/jnccn.2017.0031.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerDe novo metastatic breast cancerNovo metastatic breast cancerTM testingPET/PET-CTTumor markersBreast cancerPET-CTDisease sitesDana-Farber Cancer InstituteSerum tumor markersTiming of imagingPET-CT scanFrequency of imagingCourse of treatmentPatterns of utilizationAsymptomatic patientsNeurologic symptomsRetrospective cohortClinicopathologic factorsTreatment initiationRadiographic studiesCancer InstitutePatientsTumor subtypesPhase I dose escalation study of the PI3kinase pathway inhibitor BKM120 and the oral poly (ADP ribose) polymerase (PARP) inhibitor olaparib for the treatment of high-grade serous ovarian and breast cancer
Matulonis U, Wulf G, Barry W, Birrer M, Westin S, Farooq S, Bell-McGuinn K, Obermayer E, Whalen C, Spagnoletti T, Luo W, Liu H, Hok R, Aghajanian C, Solit D, Mills G, Taylor B, Won H, Berger M, Palakurthi S, Liu J, Cantley L, Winer E. Phase I dose escalation study of the PI3kinase pathway inhibitor BKM120 and the oral poly (ADP ribose) polymerase (PARP) inhibitor olaparib for the treatment of high-grade serous ovarian and breast cancer. Annals Of Oncology 2017, 28: 512-518. PMID: 27993796, PMCID: PMC5834157, DOI: 10.1093/annonc/mdw672.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAminopyridinesBRCA1 ProteinBRCA2 ProteinBreast NeoplasmsDose-Response Relationship, DrugFemaleGerm-Line MutationHumansMiddle AgedMorpholinesNeoplasm GradingNeoplasm Recurrence, LocalOvarian NeoplasmsPhosphoinositide-3 Kinase InhibitorsPhthalazinesPiperazinesPoly(ADP-ribose) Polymerase InhibitorsPoly(ADP-ribose) PolymerasesConceptsGermline BRCA mutationsOvarian cancerStudy treatmentPARP inhibitorsRandomized phase II studyDose-expansion cohortsPhase II studyPhase I trialDose-escalation designWild-type patientsBiomarkers of responsePARP inhibitor combinationsCombination of BKM120Polymerase inhibitor olaparibPoly (ADP-ribose) polymerase (PARP) inhibitor olaparibPI3K inhibitorsAdditional DLTsOlaparib 300Preclinical synergyRecurrent breastEscalation studyII studyI trialClinical benefitBRCA mutations
2016
Impact of neoadjuvant therapy on eligibility for and frequency of breast conservation in stage II–III HER2-positive breast cancer: surgical results of CALGB 40601 (Alliance)
Golshan M, Cirrincione CT, Sikov WM, Carey LA, Berry DA, Overmoyer B, Henry NL, Somlo G, Port E, Burstein HJ, Hudis C, Winer E, Ollila DW, for the Alliance for Clinical Trials in Oncology. Impact of neoadjuvant therapy on eligibility for and frequency of breast conservation in stage II–III HER2-positive breast cancer: surgical results of CALGB 40601 (Alliance). Breast Cancer Research And Treatment 2016, 160: 297-304. PMID: 27704226, PMCID: PMC5189982, DOI: 10.1007/s10549-016-4006-6.Peer-Reviewed Original ResearchConceptsNeoadjuvant systemic therapyBreast-conserving therapyBCT-eligible patientsPathologic complete responseSuccessful breast-conserving therapyHER2-positive breast cancerBCT eligibilityPCR rateBreast conservationSurgical assessmentBreast cancerStage IIHigh clinical response rateFinal surgical procedureClinical response rateSubset of patientsManagement of patientsPoor cosmetic outcomeSuccess rateCALGB 40601Converted patientsNeoadjuvant trialsNeoadjuvant therapyPrimary surgeryMulticentric diseaseTreatment of early-stage human epidermal growth factor 2-positive cancers among medicare enrollees: age and race strongly associated with non-use of trastuzumab
Vaz-Luis I, Lin NU, Keating NL, Barry WT, Lii J, Burstein HJ, Winer EP, Freedman RA. Treatment of early-stage human epidermal growth factor 2-positive cancers among medicare enrollees: age and race strongly associated with non-use of trastuzumab. Breast Cancer Research And Treatment 2016, 159: 151-162. PMID: 27484879, DOI: 10.1007/s10549-016-3927-4.Peer-Reviewed Original ResearchConceptsAdjuvant trastuzumabOlder patientsSystemic treatmentBreast cancerHuman epidermal growth factor receptor 2HER2-positive breast cancerEpidermal growth factor receptor 2HER2-positive diseaseStage III diseaseCongestive heart failureGrowth factor receptor 2Positive breast cancerFactor receptor 2Treatment omissionEndocrine therapyClinical characteristicsSystemic therapyHeart failureBlack patientsTreatment disparitiesTreatment patternsHuman epidermal growth factorEpidermal growth factorMedicare dataPatients
2015
Chemotherapy-related amenorrhea after adjuvant paclitaxel–trastuzumab (APT trial)
Ruddy KJ, Guo H, Barry W, Dang CT, Yardley DA, Moy B, Marcom PK, Albain KS, Rugo HS, Ellis MJ, Shapira I, Wolff AC, Carey LA, Overmoyer BA, Hudis C, Krop IE, Burstein HJ, Winer EP, Partridge AH, Tolaney SM. Chemotherapy-related amenorrhea after adjuvant paclitaxel–trastuzumab (APT trial). Breast Cancer Research And Treatment 2015, 151: 589-596. PMID: 25981899, PMCID: PMC5057177, DOI: 10.1007/s10549-015-3426-z.Peer-Reviewed Original ResearchConceptsChemotherapy-related amenorrheaChemotherapy initiationMenopausal symptomsBreast cancerAdjuvant breast cancer therapyEarly-stage breast cancerNode-negative HER2Weeks of paclitaxelStage breast cancerLast menstrual periodBreast cancer therapyAdjuvant paclitaxelAmenorrhea ratesAPT trialEligible patientsEvaluable populationPremenopausal womenAdjuvant studiesTrastuzumab monotherapyMedian timeMenstrual periodCancer regimensAmenorrheaTrastuzumabMonthsRacial and Ethnic Differences in Breast Cancer Survival: Mediating Effect of Tumor Characteristics and Sociodemographic and Treatment Factors
Warner ET, Tamimi RM, Hughes ME, Ottesen RA, Wong YN, Edge SB, Theriault RL, Blayney DW, Niland JC, Winer EP, Weeks JC, Partridge AH. Racial and Ethnic Differences in Breast Cancer Survival: Mediating Effect of Tumor Characteristics and Sociodemographic and Treatment Factors. Journal Of Clinical Oncology 2015, 33: 2254-2261. PMID: 25964252, PMCID: PMC4486344, DOI: 10.1200/jco.2014.57.1349.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAsianBiomarkers, TumorBlack or African AmericanBody Mass IndexBreast NeoplasmsCause of DeathDisease-Free SurvivalEthnicityFemaleHealth Status DisparitiesHealthcare DisparitiesHispanic or LatinoHumansLogistic ModelsMiddle AgedMultivariate AnalysisNeoplasm GradingNeoplasm StagingProportional Hazards ModelsRacial GroupsRisk FactorsSocioeconomic FactorsTime FactorsTreatment OutcomeTriple Negative Breast NeoplasmsUnited StatesWhite PeopleConceptsBreast cancer-specific survivalEstrogen receptor-positive tumorsCancer-specific survivalReceptor-positive tumorsBreast cancer survivalTumor characteristicsCancer survivalBreast cancerNational Comprehensive Cancer Network centersBreast cancer-specific deathHuman epidermal growth factor receptorCancer-specific deathMultivariable adjusted modelsYear of diagnosisBody mass indexProportional hazards regressionEpidermal growth factor receptorRace/ethnicityGrowth factor receptorHazards regressionMass indexRisk factorsSurvival differencesLike tumorsHigh risk
2014
ESO-ESMO 2nd international consensus guidelines for advanced breast cancer (ABC2) †
Cardoso F, Costa A, Norton L, Senkus E, Aapro M, André F, Barrios C, Bergh J, Biganzoli L, Blackwell K, Cardoso M, Cufer T, Saghir N, Fallowfield L, Fenech D, Francis P, Gelmon K, Giordano S, Gligorov J, Goldhirsch A, Harbeck N, Houssami N, Hudis C, Kaufman B, Krop I, Kyriakides S, Lin U, Mayer M, Merjaver S, Nordström E, Pagani O, Partridge A, Penault-Llorca F, Piccart M, Rugo H, Sledge G, Thomssen C, Veer L, Vorobiof D, Vrieling C, West N, Xu B, Winer E. ESO-ESMO 2nd international consensus guidelines for advanced breast cancer (ABC2) †. Annals Of Oncology 2014, 25: 1871-1888. PMID: 25234545, PMCID: PMC4176456, DOI: 10.1093/annonc/mdu385.Peer-Reviewed Original ResearchExtended Therapy With Letrozole and Ovarian Suppression in Premenopausal Patients With Breast Cancer After Tamoxifen
Ruddy KJ, DeSantis SD, Barry W, Guo H, Block CC, Borges V, Winer EP, Partridge AH. Extended Therapy With Letrozole and Ovarian Suppression in Premenopausal Patients With Breast Cancer After Tamoxifen. Clinical Breast Cancer 2014, 14: 413-416. PMID: 24970714, DOI: 10.1016/j.clbc.2014.04.007.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic Agents, HormonalAntineoplastic Combined Chemotherapy ProtocolsAromatase InhibitorsBreast NeoplasmsChemotherapy, AdjuvantFeasibility StudiesFemaleFollow-Up StudiesGonadotropin-Releasing HormoneHumansLetrozoleMiddle AgedNeoplasm GradingNeoplasm StagingNitrilesOvariectomyPremenopausePrognosisSurvival RateTamoxifenTriazolesConceptsPremenopausal womenAdjuvant tamoxifenEndocrine therapyExtended therapyAromatase inhibitorsBreast cancerStandard adjuvant endocrine therapyGonadotropin-releasing hormone agonistSingle-arm clinical trialPhase II single-arm clinical trialsEarly study closureYears of tamoxifenAdjuvant endocrine therapySubstantial side effectsProtocol-directed therapyCommon toxicitiesLengthier coursesPremenopausal patientsOvarian suppressionPoor accrualPostmenopausal patientsVaginal drynessHormone agonistStudy closureBone loss