2022
Treatment Exposure and Discontinuation in the PALbociclib CoLlaborative Adjuvant Study of Palbociclib With Adjuvant Endocrine Therapy for Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Early Breast Cancer (PALLAS/AFT-05/ABCSG-42/BIG-14-03).
Mayer EL, Fesl C, Hlauschek D, Garcia-Estevez L, Burstein HJ, Zdenkowski N, Wette V, Miller KD, Balic M, Mayer IA, Cameron D, Winer EP, Ponce Lorenzo JJ, Lake D, Pristauz-Telsnigg G, Haddad TC, Shepherd L, Iwata H, Goetz M, Cardoso F, Traina TA, Sabanathan D, Breitenstein U, Ackerl K, Metzger Filho O, Zehetner K, Solomon K, El-Abed S, Theall KP, Lu DR, Dueck A, Gnant M, DeMichele A. Treatment Exposure and Discontinuation in the PALbociclib CoLlaborative Adjuvant Study of Palbociclib With Adjuvant Endocrine Therapy for Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Early Breast Cancer (PALLAS/AFT-05/ABCSG-42/BIG-14-03). Journal Of Clinical Oncology 2022, 40: 449-458. PMID: 34995105, PMCID: PMC9851679, DOI: 10.1200/jco.21.01918.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic Agents, HormonalAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsChemotherapy, AdjuvantDisease-Free SurvivalFemaleHumansNeoplasm StagingPiperazinesProtein Kinase InhibitorsPyridinesReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneRisk FactorsTime FactorsConceptsInvasive disease-free survivalAdjuvant endocrine therapyHuman epidermal growth factor receptorEndocrine therapyEpidermal growth factor receptorPalbociclib exposureGrowth factor receptorBreast cancerHormone Receptor-Positive/Human Epidermal Growth Factor ReceptorAddition of palbociclibNovel adjuvant treatmentDisease-free survivalEarly breast cancerFactor receptorOral cancer therapyProtocol analysisPALLAS studyAdjuvant treatmentEarly discontinuationAdjuvant studiesDiscontinuation ratesDose modificationAnalysis populationCDK4/6 inhibitorsDrug persistence
2020
Road Map to Safe and Well-Designed De-escalation Trials of Systemic Adjuvant Therapy for Solid Tumors.
Piccart MJ, Hilbers FS, Bliss JM, Caballero C, Frank ES, Renault P, Naït Kaoudjt R, Schumacher E, Spears PA, Regan MM, Gelber RD, Davidson NE, Norton L, Winer EP. Road Map to Safe and Well-Designed De-escalation Trials of Systemic Adjuvant Therapy for Solid Tumors. Journal Of Clinical Oncology 2020, 38: 4120-4129. PMID: 33052755, DOI: 10.1200/jco.20.01382.Peer-Reviewed Original ResearchConceptsDe-escalation trialsNorth American Breast Cancer GroupBreast International GroupTreatment de-escalation trialsSystemic adjuvant therapySystemic adjuvant treatmentBreast cancer groupNoninferiority trial designAdjuvant trialsAdjuvant therapyAdjuvant treatmentCancer groupDifferent cancer typesPatient insightPatient's perspectiveEffective treatmentConsensus articleTrial designSolid tumorsField of cancerEnd pointFinancial toxicityCancer typesTrialsAdverse effects
2018
The Breast Cancer Weight Loss (BWEL) trial: Randomized phase III trial evaluating the role of weight loss in adjuvant treatment of overweight and obese women with early-stage breast cancer (Alliance A011401).
Ligibel J, Barry W, Alfano C, Hershman D, Irwin M, Neuhouser M, Thomson C, Delahanty L, Frank E, Spears P, Paskett E, Hopkins J, Bernstein V, Stearns V, White J, Wadden T, Goodwin P, Carey L, Partridge A, Winer E. The Breast Cancer Weight Loss (BWEL) trial: Randomized phase III trial evaluating the role of weight loss in adjuvant treatment of overweight and obese women with early-stage breast cancer (Alliance A011401). Journal Of Clinical Oncology 2018, 36: tps598-tps598. DOI: 10.1200/jco.2018.36.15_suppl.tps598.Peer-Reviewed Original Research
2014
Adjuvant Exemestane with Ovarian Suppression in Premenopausal Breast Cancer
Pagani O, Regan MM, Walley BA, Fleming GF, Colleoni M, Láng I, Gomez HL, Tondini C, Burstein HJ, Perez EA, Ciruelos E, Stearns V, Bonnefoi HR, Martino S, Geyer CE, Pinotti G, Puglisi F, Crivellari D, Ruhstaller T, Winer EP, Rabaglio-Poretti M, Maibach R, Ruepp B, Giobbie-Hurder A, Price KN, Bernhard J, Luo W, Ribi K, Viale G, Coates AS, Gelber RD, Goldhirsch A, Francis PA. Adjuvant Exemestane with Ovarian Suppression in Premenopausal Breast Cancer. New England Journal Of Medicine 2014, 371: 107-118. PMID: 24881463, PMCID: PMC4175521, DOI: 10.1056/nejmoa1404037.Peer-Reviewed Original ResearchMeSH KeywordsAdultAndrostadienesAntineoplastic Agents, HormonalAntineoplastic Combined Chemotherapy ProtocolsAromatase InhibitorsBreast NeoplasmsChemotherapy, AdjuvantDisease-Free SurvivalEstradiolFemaleFollow-Up StudiesHumansKaplan-Meier EstimateMastectomyMiddle AgedOsteoporosisPremenopauseQuality of LifeTamoxifenTriptorelin PamoateConceptsPositive early breast cancerEarly breast cancerOvarian suppressionBreast cancerPostmenopausal womenPremenopausal womenTamoxifen plus ovarian suppressionSuppression groupRate of freedomDisease-free survivalPhase 3 trialPremenopausal breast cancerOvarian estrogen productionPositive breast cancerAromatase inhibitor exemestaneAdjuvant exemestaneOvarian irradiationAdjuvant therapyAdjuvant treatmentAdverse eventsOverall survivalEstrogen productionAromatase inhibitorsGrade 3Primary analysis
2011
CMF revisited in the 21st century
Munzone E, Curigliano G, Burstein HJ, Winer EP, Goldhirsch A. CMF revisited in the 21st century. Annals Of Oncology 2011, 23: 305-311. PMID: 21715566, DOI: 10.1093/annonc/mdr309.Peer-Reviewed Original ResearchConceptsTriple-negative breast cancerBreast cancerClassical CMFOptimal chemotherapy backboneRecent retrospective dataUse of CMFTreatment of patientsTriple negative cellsPoly (ADP-ribose) polymerase (PARP) inhibitorsMechanism of actionAdjuvant CMFChemotherapy backboneAdjuvant treatmentRetrospective dataSpecific subgroupsPolymerase inhibitorsCancerTrue effectivenessPatientsCMFPlatinum compoundsDrugsTreatmentPast yearYears
2007
HER2 and Response to Paclitaxel in Node-Positive Breast Cancer
Hayes DF, Thor AD, Dressler LG, Weaver D, Edgerton S, Cowan D, Broadwater G, Goldstein LJ, Martino S, Ingle JN, Henderson IC, Norton L, Winer EP, Hudis CA, Ellis MJ, Berry DA. HER2 and Response to Paclitaxel in Node-Positive Breast Cancer. New England Journal Of Medicine 2007, 357: 1496-1506. PMID: 17928597, DOI: 10.1056/nejmoa071167.Peer-Reviewed Original ResearchConceptsHuman epidermal growth factor receptor type 2Node-positive breast cancerAddition of paclitaxelEstrogen receptor statusHER2 positivityBreast cancerAdjuvant chemotherapyDoxorubicin dosesAdjuvant anthracycline-based chemotherapyEpidermal growth factor receptor type 2HER2-positive breast cancerFactor receptor type 2CB11 monoclonal antibodyCycles of paclitaxelAnthracycline-based chemotherapyAdministration of paclitaxelReceptor type 2Breast cancer cellsAdjuvant treatmentHazard ratioClinical outcomesPositive cancersHER2 amplificationImmunohistochemical analysisCyclophosphamideImpact of physical activity on insulin levels in breast cancer survivors
Ligibel J, Campbell N, Chen H, Salinardi T, Chen W, Partridge A, Mantzoros C, Winer E. Impact of physical activity on insulin levels in breast cancer survivors. Journal Of Clinical Oncology 2007, 25: 555-555. DOI: 10.1200/jco.2007.25.18_suppl.555.Peer-Reviewed Original ResearchBreast cancer survivorsInsulin levelsPhysical activityCancer survivorsExercise groupΜIU/Glucose levelsControl groupEarly-stage breast cancerBreast cancer-related deathsBaseline insulin levelsCare control groupStage breast cancerBreast cancer recurrenceBreast cancer riskCancer-related deathBreast cancer prognosisStrength training sessionMeasurements of weightAdjuvant treatmentExercise interventionHip circumferenceInsulin sensitivityCancer recurrenceFat mass
2006
Estrogen-Receptor Status and Outcomes of Modern Chemotherapy for Patients With Node-Positive Breast Cancer
Berry DA, Cirrincione C, Henderson IC, Citron ML, Budman DR, Goldstein LJ, Martino S, Perez EA, Muss HB, Norton L, Hudis C, Winer EP. Estrogen-Receptor Status and Outcomes of Modern Chemotherapy for Patients With Node-Positive Breast Cancer. JAMA 2006, 295: 1658-1667. PMID: 16609087, PMCID: PMC1459540, DOI: 10.1001/jama.295.14.1658.Peer-Reviewed Original ResearchConceptsER-positive tumorsER-positive patientsEstrogen receptor statusAdjuvant chemotherapyOverall survivalBreast cancerBreast cancer estrogen receptor statusNode-positive breast cancer patientsNode-positive breast cancerER-negative breast cancerDoxorubicin/cyclophosphamideRegimens of cyclophosphamideER-negative patientsLeukemia Group BLow-dose cyclophosphamideNode-positive tumorsBreast cancer patientsRate of recurrenceRelative risk reductionER-negative tumorsMortality rate reductionAdjuvant treatmentEndocrine therapyER statusRandomized trialsAromatase Inhibitors in the Adjuvant Treatment of Postmenopausal Women with Early Stage Breast Cancer
Ligibel JA, Winer EP. Aromatase Inhibitors in the Adjuvant Treatment of Postmenopausal Women with Early Stage Breast Cancer. Women's Health 2006, 2: 89-97. PMID: 19803930, DOI: 10.2217/17455057.2.1.89.Peer-Reviewed Original Research
2003
Randomized trial of dose-dense versus conventionally scheduled and sequential versus concurrent combination chemotherapy as postoperative adjuvant treatment of node-positive primary breast cancer: first report of Intergroup Trial C9741/Cancer and Leukemia Group B Trial 9741.
Citron ML, Berry DA, Cirrincione C, Hudis C, Winer EP, Gradishar WJ, Davidson NE, Martino S, Livingston R, Ingle JN, Perez EA, Carpenter J, Hurd D, Holland JF, Smith BL, Sartor CI, Leung EH, Abrams J, Schilsky RL, Muss HB, Norton L. Randomized trial of dose-dense versus conventionally scheduled and sequential versus concurrent combination chemotherapy as postoperative adjuvant treatment of node-positive primary breast cancer: first report of Intergroup Trial C9741/Cancer and Leukemia Group B Trial 9741. Journal Of Clinical Oncology 2003, 21: 1431-9. PMID: 12668651, DOI: 10.1200/jco.2003.09.081.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsChemotherapy, AdjuvantCyclophosphamideDoxorubicinDrug Administration ScheduleFemaleFilgrastimGranulocyte Colony-Stimulating FactorHumansMiddle AgedMultivariate AnalysisPaclitaxelProportional Hazards ModelsRecombinant ProteinsSurvival AnalysisTreatment OutcomeConceptsOverall survivalDose-dense regimensBreast cancerAxillary node-positive breast cancerNode-positive primary breast cancerNode-positive breast cancerConcurrent combination chemotherapyDose-dense treatmentProtocol-specified analysisPostoperative adjuvant treatmentPrimary end pointPrimary breast cancerDose densityAdjuvant chemotherapyConcurrent chemotherapyAdjuvant treatmentSequential chemotherapySevere neutropeniaCombination chemotherapyClinical outcomesFemale patientsTreatment failureSequential doxorubicinConcurrent doxorubicinChemotherapy
1999
Is axillary lymph node dissection indicated for early-stage breast cancer? A decision analysis.
Parmigiani G, Berry D, Winer E, Tebaldi C, Iglehart J, Prosnitz L. Is axillary lymph node dissection indicated for early-stage breast cancer? A decision analysis. Journal Of Clinical Oncology 1999, 17: 1465-73. PMID: 10334532, DOI: 10.1200/jco.1999.17.5.1465.Peer-Reviewed Original ResearchConceptsAxillary lymph node dissectionBenefits of ALNDLymph node dissectionQuality of lifeAdjuvant chemotherapyAdjuvant therapyNode dissectionBreast cancerLeukemia Group B StudyEarly-stage breast cancerRoutine useAxillary radiation therapyER-negative womenER-positive womenAdjuvant systemic therapySmall primary tumorsBreast-conserving therapyBreast cancer patientsEstrogen receptor statusNegative axillaOxford OverviewAdjuvant treatmentChemotherapy combinationsSurvival benefitSystemic therapy
1998
Quality of life and preferences for treatment following systemic adjuvant therapy for early-stage breast cancer.
Lindley C, Vasa S, Sawyer WT, Winer EP. Quality of life and preferences for treatment following systemic adjuvant therapy for early-stage breast cancer. Journal Of Clinical Oncology 1998, 16: 1380-7. PMID: 9552041, DOI: 10.1200/jco.1998.16.4.1380.Peer-Reviewed Original ResearchConceptsFunctional Living Index-CancerQuality of lifeEarly-stage breast cancerSystemic adjuvant therapyMonths of chemotherapySymptom Distress ScaleAdjuvant therapySexual functionBreast cancerSevere symptomsMedical Outcomes Study Short Form-36Self-rated QOLThird of patientsMajority of patientsShort Form-36Breast cancer patientsPatient's physical symptomsSite of surgeryModest potential benefitAdjuvant cytotoxicAdjuvant treatmentHormonal therapyIndex cancerForm-36Local numbness