2012
Six Cycles of Doxorubicin and Cyclophosphamide or Paclitaxel Are Not Superior to Four Cycles As Adjuvant Chemotherapy for Breast Cancer in Women With Zero to Three Positive Axillary Nodes: Cancer and Leukemia Group B 40101
Shulman LN, Cirrincione CT, Berry DA, Becker HP, Perez EA, O'Regan R, Martino S, Atkins JN, Mayer E, Schneider CJ, Kimmick G, Norton L, Muss H, Winer EP, Hudis C. Six Cycles of Doxorubicin and Cyclophosphamide or Paclitaxel Are Not Superior to Four Cycles As Adjuvant Chemotherapy for Breast Cancer in Women With Zero to Three Positive Axillary Nodes: Cancer and Leukemia Group B 40101. Journal Of Clinical Oncology 2012, 30: 4071-4076. PMID: 22826271, PMCID: PMC3494835, DOI: 10.1200/jco.2011.40.6405.Peer-Reviewed Original ResearchConceptsRelapse-free survivalHuman epidermal growth factor receptor 2Primary breast cancerPositive nodesBreast cancerHazard ratioAdjuvant chemotherapyChemotherapy regimenEstrogen receptor/progesterone receptorPrimary efficacy end pointEpidermal growth factor receptor 2Dose-dense fashionDoxorubicin/cyclophosphamideAdjusted hazard ratioCycles of doxorubicinEfficacy end pointOperable breast cancerPositive axillary nodesER/PgRGrowth factor receptor 2Factor receptor 2Chemotherapy regimensAxillary nodesMenopausal statusClinical outcomes
2009
Benefits of Adding Paclitaxel to Adjuvant Doxorubicin/Cyclophosphamide Depending on HER2 & ER Status: Analysis of Tumor Tissue Microarrays and Immunohistochemistry in CALGB 9344 (Intergroup 0148).
Berry D, Berry D, Thor A, Jewell S, Broadwater G, Edgerton S, Hayes D, Hudis C, Winer E, Nielsen T, Ellis M. Benefits of Adding Paclitaxel to Adjuvant Doxorubicin/Cyclophosphamide Depending on HER2 & ER Status: Analysis of Tumor Tissue Microarrays and Immunohistochemistry in CALGB 9344 (Intergroup 0148). Cancer Research 2009, 69: 606-606. DOI: 10.1158/0008-5472.sabcs-09-606.Peer-Reviewed Original ResearchAdjuvant doxorubicin/cyclophosphamideNode-positive breast cancerWhole section analysisTissue microarrayHazard ratioER statusBreast cancerAdjuvant phase III trialsDouble-negative tumorsDoxorubicin/cyclophosphamideNon-responding patientsPhase III trialsMajority of patientsMultivariate Cox modelConfidence intervalsTumor tissue microarraysSet of patientsTMA cohortHormonal therapyIII trialsSurvival benefitCentral pathologyPathology blocksKaplan-MeierClinical assessment
2008
Lymphopenia Associated with Adjuvant Anthracycline/Taxane Regimens
Tolaney SM, Najita J, Winer EP, Burstein HJ. Lymphopenia Associated with Adjuvant Anthracycline/Taxane Regimens. Clinical Breast Cancer 2008, 8: 352-356. PMID: 18757263, DOI: 10.3816/cbc.2008.n.041.Peer-Reviewed Original ResearchConceptsDose-dense ACPneumocystis carinii pneumoniaDose-dense chemotherapyCells/mm3Absolute lymphocyte countAbsolute neutrophil countAlbumin-bound paclitaxelLymphocyte countCohort 2Cohort 1Lymphocyte depletionOpportunistic infectionsCohort 3Day 1Cases of PCPLow absolute lymphocyte countDana-Farber Cancer InstitutePhase II clinical trialDoxorubicin/cyclophosphamideGrade 3/4 lymphopeniaGrade 4 lymphopeniaHIV-negative patientsMedian lymphocyte countPhase II studyCohort of patients
2007
Dose-dense nab-paclitaxel (nanoparticle albumin-bound paclitaxel) in adjuvant chemotherapy for breast cancer: A feasibility study
Burstein H, Mayer E, Peppercorn J, Parker L, Hannagan K, Moy B, Younger J, Schapira L, Wulf G, Gelman R, Winer E. Dose-dense nab-paclitaxel (nanoparticle albumin-bound paclitaxel) in adjuvant chemotherapy for breast cancer: A feasibility study. Journal Of Clinical Oncology 2007, 25: 594-594. DOI: 10.1200/jco.2007.25.18_suppl.594.Peer-Reviewed Original ResearchG-CSF supportNab-paclitaxelFebrile neutropeniaTreatment delayBreast cancerDoxorubicin/cyclophosphamideNab-paclitaxel therapyQuality of lifeDose-denseAdjuvant chemotherapyEligible patientsNeoadjuvant chemotherapyTaxane chemotherapyDose reductionFull cohortStage IPatientsNeutropeniaChemotherapyInstitutional studyPaclitaxelSignificant financial relationshipCycle 6CancerPrior studies
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 trials
2005
Efficacy of Pegfilgrastim and Darbepoetin Alfa As Hematopoietic Support for Dose-Dense Every-2-Week Adjuvant Breast Cancer Chemotherapy
Burstein HJ, Parker LM, Keshaviah A, Doherty J, Partridge AH, Schapira L, Ryan PD, Younger J, Harris LN, Moy B, Come SE, Schumer ST, Bunnell CA, Haldoupis M, Gelman R, Winer EP. Efficacy of Pegfilgrastim and Darbepoetin Alfa As Hematopoietic Support for Dose-Dense Every-2-Week Adjuvant Breast Cancer Chemotherapy. Journal Of Clinical Oncology 2005, 23: 8340-8347. PMID: 16293865, DOI: 10.1200/jco.2005.02.8621.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAlgorithmsAnemiaAntineoplastic Combined Chemotherapy ProtocolsBostonBreast NeoplasmsChemotherapy, AdjuvantCyclophosphamideDarbepoetin alfaDoxorubicinErythrocyte TransfusionErythropoietinFemaleFilgrastimGranulocyte Colony-Stimulating FactorHumansMiddle AgedNeutropeniaPaclitaxelPolyethylene GlycolsRecombinant ProteinsTreatment OutcomeConceptsDose-dense ACPercentage of patientsRBC transfusionFebrile neutropeniaDarbepoetin alfaAdjuvant chemotherapyAdjuvant breast cancer chemotherapyDarbepoetin alfa therapyDoxorubicin/cyclophosphamidePrimary end pointSingle-arm studyBreast cancer chemotherapyEfficacy of pegfilgrastimHematopoietic growth factorsAlfa therapyDose-densePaclitaxel cyclesHematologic toxicityArm studyBreast cancerModest leukocytosisHematopoietic supportPatientsStage ITransfusion
2003
Preoperative Therapy With Trastuzumab and Paclitaxel Followed by Sequential Adjuvant Doxorubicin/Cyclophosphamide for HER2 Overexpressing Stage II or III Breast Cancer: A Pilot Study
Burstein HJ, Harris LN, Gelman R, Lester SC, Nunes RA, Kaelin CM, Parker LM, Ellisen LW, Kuter I, Gadd MA, Christian RL, Kennedy PR, Borges VF, Bunnell CA, Younger J, Smith BL, Winer EP. Preoperative Therapy With Trastuzumab and Paclitaxel Followed by Sequential Adjuvant Doxorubicin/Cyclophosphamide for HER2 Overexpressing Stage II or III Breast Cancer: A Pilot Study. Journal Of Clinical Oncology 2003, 21: 46-53. PMID: 12506169, DOI: 10.1200/jco.2003.03.124.Peer-Reviewed Original ResearchConceptsHuman epidermal growth factor receptor 2Early-stage breast cancerPreoperative trastuzumabBreast cancerPreoperative therapyHER2 extracellular domainAdjuvant doxorubicinCyclophosphamide chemotherapyAdjuvant doxorubicin/cyclophosphamideStage IILeft ventricular ejection fractionEpidermal growth factor receptor 2Pilot studyDefinitive breast surgeryDoxorubicin/cyclophosphamideGrade 2 cardiotoxicityPathologic response rateAdvanced breast cancerComplete pathologic responseTrastuzumab-based treatmentGrowth factor receptor 2Ventricular ejection fractionStage breast cancerFactor receptor 2Sequential treatment program