2020
Avoiding Peg-Filgrastim Prophylaxis During the Paclitaxel Portion of the Dose-Dense Doxorubicin-Cyclophosphamide and Paclitaxel Regimen: A Prospective Study
Vaz-Luis I, Barroso-Sousa R, Di Meglio A, Hu J, Rees R, Sinclair N, Milisits L, Leone JP, Constantine M, Faggen M, Briccetti F, Block C, O'Neil K, Partridge A, Burstein H, Waks AG, Trippa L, Tolaney SM, Hassett M, Winer EP, Lin NU. Avoiding Peg-Filgrastim Prophylaxis During the Paclitaxel Portion of the Dose-Dense Doxorubicin-Cyclophosphamide and Paclitaxel Regimen: A Prospective Study. Journal Of Clinical Oncology 2020, 38: 2390-2397. PMID: 32330102, PMCID: PMC7367545, DOI: 10.1200/jco.19.02484.Peer-Reviewed Original ResearchConceptsDose-dense paclitaxelPeg-filgrastimFebrile neutropeniaDay 1Adjuvant breast cancer chemotherapyCycle 1 day 1Patient experienced febrile neutropeniaCycles of paclitaxelDose-dense doxorubicinExperienced febrile neutropeniaPrimary end pointSingle-arm studyBreast cancer chemotherapyYears of ageDose delaysDoxorubicin-cyclophosphamidePaclitaxel cyclesPaclitaxel regimenPatients 18Investigator's discretionMedian ageTreatment delayProspective studyPrespecified algorithmBreast cancer
2010
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
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
Dose-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
Dose-escalation of filgrastim does not improve efficacy: Clinical tolerability and long-term follow-up on CALGB study 9141 adjuvant chemotherapy for node-positive breast cancer patients using dose-intensified doxorubicin plus cyclophosphamide followed by paclitaxel
Liu MC, Demetri GD, Berry DA, Norton L, Broadwater G, Robert NJ, Duggan D, Hayes DF, Henderson IC, Lyss A, Hopkins J, Kaufman PA, Marcom PK, Younger J, Lin N, Tkaczuk K, Winer EP, Hudis CA, B F. Dose-escalation of filgrastim does not improve efficacy: Clinical tolerability and long-term follow-up on CALGB study 9141 adjuvant chemotherapy for node-positive breast cancer patients using dose-intensified doxorubicin plus cyclophosphamide followed by paclitaxel. Cancer Treatment Reviews 2008, 34: 223-230. PMID: 18234424, PMCID: PMC2651678, DOI: 10.1016/j.ctrv.2007.11.004.Peer-Reviewed Original ResearchMeSH KeywordsAdultAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsChemotherapy, AdjuvantCyclophosphamideDisease-Free SurvivalDoxorubicinFemaleFilgrastimFollow-Up StudiesGranulocyte Colony-Stimulating FactorHumansLymphatic MetastasisMiddle AgedPaclitaxelPilot ProjectsRecombinant ProteinsConceptsG-CSF supportGrowth factor supportRelapse-free survivalClinical outcomesDose levelsG-CSFFactor supportConventional doseClinical trialsBreast cancerNode-positive invasive breast cancerNode-positive breast cancer patientsAcute treatment-related toxicityHematopoietic growth factor supportOperable primary breast cancerAdjuvant chemotherapy regimenDose-intensified regimenDose-intensive regimensEarly study withdrawalNode-positive patientsTreatment-related toxicityHormone receptor statusInvasive breast cancerOverall survival ratePrimary breast cancer
2006
Pneumocystis Carinii Pneumonia During Dose-Dense Chemotherapy for Breast Cancer
Tolaney SM, Partridge AH, Sheib RG, Burstein HJ, Winer EP. Pneumocystis Carinii Pneumonia During Dose-Dense Chemotherapy for Breast Cancer. Journal Of Clinical Oncology 2006, 24: 5330-5331. PMID: 17114668, DOI: 10.1200/jco.2006.08.1083.Peer-Reviewed Original ResearchAntiemeticsAnti-Infective AgentsAnti-Inflammatory AgentsAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCarcinoma, Ductal, BreastCyclophosphamideDexamethasoneDoxorubicinFemaleFeverFilgrastimGranulocyte Colony-Stimulating FactorHumansMiddle AgedNeutropeniaPaclitaxelPneumonia, PneumocystisPolyethylene GlycolsPrednisoneRecombinant ProteinsTrimethoprim, Sulfamethoxazole Drug Combination
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
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
Inability to escalate vinorelbine dose intensity using a daily × 3 schedule with and without filgrastim in patients with metastatic breast cancer
Havlin K, Ramirez M, Legler C, Harris L, Matulonis U, Hohneker J, Hayes D, Winer E. Inability to escalate vinorelbine dose intensity using a daily × 3 schedule with and without filgrastim in patients with metastatic breast cancer. Cancer Chemotherapy And Pharmacology 1999, 43: 68-72. PMID: 9923543, DOI: 10.1007/s002800050864.Peer-Reviewed Original ResearchConceptsDana-Farber Cancer InstituteDuke University Medical CenterDose-limiting toxicityGrowth factor supportGrade III neurotoxicityMetastatic breast cancerFebrile neutropeniaBreast cancerFactor supportNonhematologic toxicityStarting doseDose intensityDay 4Stage IV breast cancerMajor dose-limiting toxicityAddition of filgrastimAlternative treatment regimenGrade III stomatitisGrade III vomitingGrade IV mucositisGrade IV thrombocytopeniaGreater nonhematologic toxicityPerformance status 0Prior chemotherapy regimensSemisynthetic vinca alkaloid