2019
CALGB (Alliance) 40603: Long-term outcomes (LTOs) after neoadjuvant chemotherapy (NACT) +/- carboplatin (Cb) and bevacizumab (Bev) in triple-negative breast cancer (TNBC).
Sikov W, Polley M, Twohy E, Perou C, Singh B, Berry D, Tolaney S, Somlo G, Port E, Ma C, Kuzma C, Mamounas E, Golshan M, Bellon J, Collyar D, Hahn O, Hudis C, Winer E, Partridge A, Carey L. CALGB (Alliance) 40603: Long-term outcomes (LTOs) after neoadjuvant chemotherapy (NACT) +/- carboplatin (Cb) and bevacizumab (Bev) in triple-negative breast cancer (TNBC). Journal Of Clinical Oncology 2019, 37: 591-591. DOI: 10.1200/jco.2019.37.15_suppl.591.Peer-Reviewed Original ResearchTriple-negative breast cancerLong-term outcomesNeoadjuvant chemotherapyPoor outcomeResidual diseaseUntreated triple-negative breast cancerBetter long-term outcomesClinical stage IIDose-dense ACPretreatment clinical stageWeeks of paclitaxelPathologic complete responseResidual cancer burdenStandard neoadjuvant chemotherapyClinical trial informationBreast/axillaBetter EFSPrimary endpointStandard chemotherapyComplete responseTreatment armsCancer burdenChemotherapy dosesClinical stageTrial arms
2015
Pneumocystis jiroveci pneumonia (PCP) in patients receiving neoadjuvant and adjuvant anthracycline-based chemotherapy for breast cancer: incidence and risk factors
Waks AG, Tolaney SM, Galar A, Arnaout A, Porter JB, Marty FM, Winer EP, Hammond SP, Baden LR. Pneumocystis jiroveci pneumonia (PCP) in patients receiving neoadjuvant and adjuvant anthracycline-based chemotherapy for breast cancer: incidence and risk factors. Breast Cancer Research And Treatment 2015, 154: 359-367. PMID: 26420402, DOI: 10.1007/s10549-015-3573-2.Peer-Reviewed Original ResearchConceptsPneumocystis jiroveci pneumoniaCases of PCPEarly-stage breast cancerBreast cancerJiroveci pneumoniaAC chemotherapyRisk factorsDana-Farber Cancer Institute/BrighamNon-metastatic breast cancer patientsAdjuvant anthracycline-based chemotherapyEarly-stage breast cancer treatmentAdriamycin/cyclophosphamideDose-dense ACAnthracycline-based chemotherapyDose-dense scheduleBreast cancer patientsBreast cancer treatmentEquivalents/dayCalculate incidenceCorticosteroid doseNausea prophylaxisSame chemotherapyOpportunistic infectionsOverall incidencePCP incidence
2013
Clinical and translational results of CALGB 40601: A neoadjuvant phase III trial of weekly paclitaxel and trastuzumab with or without lapatinib for HER2-positive breast cancer.
Carey L, Berry D, Ollila D, Harris L, Krop I, Weckstein D, Henry N, Anders C, Cirrincione C, Winer E, Perou C, Hudis C. Clinical and translational results of CALGB 40601: A neoadjuvant phase III trial of weekly paclitaxel and trastuzumab with or without lapatinib for HER2-positive breast cancer. Journal Of Clinical Oncology 2013, 31: 500-500. DOI: 10.1200/jco.2013.31.15_suppl.500.Peer-Reviewed Original ResearchHER2-positive breast cancerBreast pCR ratePathological complete responsePCR rateCALGB 40601Weekly paclitaxelResidual diseaseBreast cancerStage IIClinical stage IIDose-dense ACPhase III trialsProgression-free survivalHER2-targeted agentsBiomarkers of sensitivityGene copy number abnormalitiesTissue-based studiesEligible patientsNeoadjuvant settingNeoadjuvant studiesTH armPrimary endpointIII trialsMetastatic diseaseComplete response
2010
Randomized phase II trial of adding carboplatin and/or bevacizumab to neoadjuvant weekly paclitaxel and dose-dense AC in triple-negative breast cancer.
Sikov W, Perou C, Golshan M, Collyar D, Berry D, Hahn O, Singh B, Hudis C, Winer E. Randomized phase II trial of adding carboplatin and/or bevacizumab to neoadjuvant weekly paclitaxel and dose-dense AC in triple-negative breast cancer. Journal Of Clinical Oncology 2010, 28: tps110-tps110. DOI: 10.1200/jco.2010.28.15_suppl.tps110.Peer-Reviewed Original ResearchDose-Dense Doxorubicin and Cyclophosphamide Followed by Weekly Paclitaxel With Trastuzumab and Lapatinib in HER2/neu–Overexpressed/Amplified Breast Cancer Is Not Feasible Because of Excessive Diarrhea
Dang C, Lin N, Moy B, Come S, Sugarman S, Morris P, Abbruzzi A, Chen C, Steingart R, Patil S, Norton L, Winer E, Hudis C. Dose-Dense Doxorubicin and Cyclophosphamide Followed by Weekly Paclitaxel With Trastuzumab and Lapatinib in HER2/neu–Overexpressed/Amplified Breast Cancer Is Not Feasible Because of Excessive Diarrhea. Journal Of Clinical Oncology 2010, 28: 2982-2988. PMID: 20479410, PMCID: PMC3664034, DOI: 10.1200/jco.2009.26.5900.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCyclophosphamideDiarrheaDose-Response Relationship, DrugDoxorubicinFeasibility StudiesFemaleFilgrastimFollow-Up StudiesGene AmplificationGranulocyte Colony-Stimulating FactorHumansImmunoenzyme TechniquesIn Situ Hybridization, FluorescenceLapatinibMiddle AgedNeoplasm Recurrence, LocalNeoplasm StagingPaclitaxelPilot ProjectsPolyethylene GlycolsQuinazolinesReceptor, ErbB-2Recombinant ProteinsSurvival RateTrastuzumabTreatment OutcomeConceptsDose-dense ACDose-dense doxorubicinGrade 3 diarrheaBreast cancerDose reductionDose delay/reductionHER2-positive breast cancerHuman epidermal growth factor receptorAsymptomatic LVEF declineCardiac event ratePrimary end pointCongestive heart failureMetastatic breast cancerVentricular ejection fractionDelays/reductionsEpidermal growth factor receptorExcessive diarrheaGrowth factor receptorLVEF declineWeekly paclitaxelEjection fractionHeart failureMedian agePatientsStage I
2009
Surgical Complications and the Use of Neoadjuvant Bevacizumab.
Golshan M, Garber J, Gelman R, Tung N, Smith B, Troyan S, Greenberg C, Winer E, Ryan P. Surgical Complications and the Use of Neoadjuvant Bevacizumab. Cancer Research 2009, 69: 43-43. DOI: 10.1158/0008-5472.sabcs-09-43.Peer-Reviewed Original ResearchTriple-negative breast cancerDefinitive local therapyPhase II trialPostoperative complicationsNeoadjuvant cisplatinDefinitive surgeryII trialWound breakdownLocal therapyMedian ageBreast cancerSingle-arm phase II trialArm phase II trialTwo-sided Fisher's exact testClinical stage IIDose-dense ACSafety of bevacizumabOperable breast cancerBreast cancer surgerySingle-arm trialNegative breast cancerFisher's exact testCycles cisplatinNeoadjuvant bevacizumabNeoadjuvant settingDose-Dense Adjuvant Doxorubicin and Cyclophosphamide Is Not Associated With Frequent Short-Term Changes in Left Ventricular Ejection Fraction
Morris PG, Dickler M, McArthur HL, Traina T, Sugarman S, Lin N, Moy B, Come S, Godfrey L, Nulsen B, Chen C, Steingart R, Rugo H, Norton L, Winer E, Hudis CA, Dang CT. Dose-Dense Adjuvant Doxorubicin and Cyclophosphamide Is Not Associated With Frequent Short-Term Changes in Left Ventricular Ejection Fraction. Journal Of Clinical Oncology 2009, 27: 6117-6123. PMID: 19901120, PMCID: PMC3664032, DOI: 10.1200/jco.2008.20.2952.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabBreast NeoplasmsCardiac ElectrophysiologyChemotherapy, AdjuvantCyclophosphamideDose-Response Relationship, DrugDoxorubicinFemaleFilgrastimGranulocyte Colony-Stimulating FactorHeart DiseasesHumansMiddle AgedPaclitaxelPolyethylene GlycolsRecombinant ProteinsStroke VolumeTrastuzumabTreatment OutcomeVentricular Function, LeftConceptsLeft ventricular ejection fractionMedian left ventricular ejection fractionDose-dense ACVentricular ejection fractionEjection fractionBreast cancerHER2-normal breast cancerHER2-positive breast cancerTargeted biologic therapiesAdjuvant doxorubicinConcurrent bevacizumabSame regimenBiologic therapyAsymptomatic declineMedian ageMonth 6Cardiac dysfunctionCardiac safetyLVEF measurementsAngiography scansPatientsEarly riskSequential studyThird weekBevacizumab
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
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 ITransfusionDose-dense (DD) AC followed by paclitaxel is associated with moderate, frequent anemia compared to sequential (S) and/or less DD Treatment: Update by CALGB on Breast Cancer Intergroup Trial C9741 with ECOG, SWOG, & NCCTG
Citron M, Berry D, Cirrincione C, Livingston R, Gradishar W, Perez E, Muss H, Norton L, Winer E, Hudis C. Dose-dense (DD) AC followed by paclitaxel is associated with moderate, frequent anemia compared to sequential (S) and/or less DD Treatment: Update by CALGB on Breast Cancer Intergroup Trial C9741 with ECOG, SWOG, & NCCTG. Journal Of Clinical Oncology 2005, 23: 620-620. DOI: 10.1200/jco.2005.23.16_suppl.620.Peer-Reviewed Original Research