2019
Avoiding peg-filgrastim (Peg-F) prophylaxis during the paclitaxel (T) portion of the dose-dense (DD) doxorubicin-cyclophosphamide (AC)-T regimen: A prospective study.
Barroso-Sousa R, Luis I, Di Meglio A, Hu J, Rees R, Sinclair N, Milisits L, Leone J, Constantine M, Faggen M, Briccetti F, Block C, Partridge A, Burstein H, Waks A, Trippa L, Tolaney S, Hassett M, Winer E, Lin N. Avoiding peg-filgrastim (Peg-F) prophylaxis during the paclitaxel (T) portion of the dose-dense (DD) doxorubicin-cyclophosphamide (AC)-T regimen: A prospective study. Journal Of Clinical Oncology 2019, 37: 517-517. DOI: 10.1200/jco.2019.37.15_suppl.517.Peer-Reviewed Original ResearchAbsolute neutrophil countFebrile neutropeniaDd ACGrowth factorAdjuvant breast cancer chemotherapyCycle 1 day 1Dose-dense doxorubicinSingle-arm studyBreast cancer chemotherapyPre-specified algorithmT regimenHematologic toxicityProtocol therapySecondary endpointsPrimary endpointDose modificationInvestigator's discretionMedian ageNeutrophil countProspective studyTreatment delayDose reductionCommon reasonRegimenDay 1
2017
A phase II study of eribulin mesylate in combination with trastuzumab and pertuzumab in patients (pts) with human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer (MBC).
Luis I, Guo H, Barry W, Krop I, Wagle N, Lowe A, Gore D, Andrews C, Osmani W, Isakoff S, Tung N, Winer E, Lin N, Freedman R. A phase II study of eribulin mesylate in combination with trastuzumab and pertuzumab in patients (pts) with human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer (MBC). Journal Of Clinical Oncology 2017, 35: 1034-1034. DOI: 10.1200/jco.2017.35.15_suppl.1034.Peer-Reviewed Original ResearchMetastatic breast cancerOverall response ratePhase II studyStable diseasePertuzumab exposureAdverse eventsII studyCohort AHuman epidermal growth factor receptorActivity of eribulinDose of eribulinFrequent grade 3First-line settingMost adverse eventsAnti-HER2 therapyCorrelative studiesEpidermal growth factor receptorCell-free DNAGrowth factor receptorHematologic toxicityCohort studyOverall survivalPartial responseCohort BSingle center
2014
Comparison of Doxorubicin and Cyclophosphamide Versus Single-Agent Paclitaxel As Adjuvant Therapy for Breast Cancer in Women With 0 to 3 Positive Axillary Nodes: CALGB 40101 (Alliance)
Shulman LN, Berry DA, Cirrincione CT, Becker HP, Perez EA, O'Regan R, Martino S, Shapiro CL, Schneider CJ, Kimmick G, Burstein HJ, Norton L, Muss H, Hudis CA, Winer EP. Comparison of Doxorubicin and Cyclophosphamide Versus Single-Agent Paclitaxel As Adjuvant Therapy for Breast Cancer in Women With 0 to 3 Positive Axillary Nodes: CALGB 40101 (Alliance). Journal Of Clinical Oncology 2014, 32: 2311-2317. PMID: 24934787, PMCID: PMC4105484, DOI: 10.1200/jco.2013.53.7142.Peer-Reviewed Original ResearchConceptsRelapse-free survivalSingle-agent paclitaxelOverall survivalHazard ratioBreast cancerTreatment-related deathsCycles of therapyOperable breast cancerPositive axillary nodesPrimary end pointDuration of therapyOptimal adjuvant chemotherapyComparison of doxorubicinAdjuvant chemotherapyCALGB 40101Median followAdjuvant therapyHematologic toxicityPositive nodesAxillary nodesPatient deathBalance efficacyPatientsEnd pointTherapy
2013
Comparison of doxorubicin and cyclophosphamide (AC) versus single-agent paclitaxel (T) as adjuvant therapy for breast cancer in women with 0-3 positive axillary nodes: CALGB 40101.
Shulman L, Berry D, Cirrincione C, Becker H, Perez E, O'Regan R, Martino S, Shapiro C, Atkins J, Schneider C, Kimmick G, Burstein H, Norton L, Muss H, Hudis C, Winer E. Comparison of doxorubicin and cyclophosphamide (AC) versus single-agent paclitaxel (T) as adjuvant therapy for breast cancer in women with 0-3 positive axillary nodes: CALGB 40101. Journal Of Clinical Oncology 2013, 31: 1007-1007. DOI: 10.1200/jco.2013.31.15_suppl.1007.Peer-Reviewed Original ResearchRelapse-free survivalHazard ratioOverall survivalBreast cancerEarly-stage breast cancerCycles of therapyNon-hematologic toxicitiesOperable breast cancerPositive axillary nodesSingle-agent paclitaxelTreatment-related deathsOptimal adjuvant chemotherapyStage breast cancerConfidence intervalsComparison of doxorubicinAdjuvant chemotherapyCALGB 40101Hematologic toxicityAdjuvant therapyPositive nodesPrimary endpointAxillary nodesVs. 4Conclusion of equivalenceGrade 3
2012
CALGB 40502/NCCTG N063H: Randomized phase III trial of weekly paclitaxel (P) compared to weekly nanoparticle albumin bound nab-paclitaxel (NP) or ixabepilone (Ix) with or without bevacizumab (B) as first-line therapy for locally recurrent or metastatic breast cancer (MBC).
Rugo H, Barry W, Moreno-Aspitia A, Lyss A, Cirrincione C, Mayer E, Naughton M, Layman R, Carey L, Somer R, Perez E, Hudis C, Winer E. CALGB 40502/NCCTG N063H: Randomized phase III trial of weekly paclitaxel (P) compared to weekly nanoparticle albumin bound nab-paclitaxel (NP) or ixabepilone (Ix) with or without bevacizumab (B) as first-line therapy for locally recurrent or metastatic breast cancer (MBC). Journal Of Clinical Oncology 2012, 30: cra1002-cra1002. DOI: 10.1200/jco.2012.30.18_suppl.cra1002.Peer-Reviewed Original ResearchProgression-free survivalMetastatic breast cancerNab-paclitaxelPhase III trialsSensory neuropathyHazard ratioIII trialsInterim analysisGrade 2 sensory neuropathyMedian progression-free survivalAlbumin-bound formulationWeekly nanoparticle albuminPrimary end pointFirst-line therapyHormone receptor statusCause deathMeasurable diseaseWeek dosingWeekly paclitaxelHematologic toxicityFree survivalReceptor statusTaxane useExperimental armNanoparticle albumin
2007
Toxicity of Older and Younger Patients Treated With Adjuvant Chemotherapy for Node-Positive Breast Cancer: The Cancer and Leukemia Group B Experience
Muss HB, Berry DA, Cirrincione C, Budman DR, Henderson IC, Citron ML, Norton L, Winer EP, Hudis CA. Toxicity of Older and Younger Patients Treated With Adjuvant Chemotherapy for Node-Positive Breast Cancer: The Cancer and Leukemia Group B Experience. Journal Of Clinical Oncology 2007, 25: 3699-3704. PMID: 17704418, DOI: 10.1200/jco.2007.10.9710.Peer-Reviewed Original ResearchConceptsAdjuvant chemotherapy regimensTreatment-related deathsYounger patientsAdjuvant chemotherapyHematologic toxicityNonhematologic toxicityChemotherapy regimensOlder patientsGrade 3Acute myeloid leukemia/myelodysplastic syndromeNational Cancer Institute grade 3Grade 4 hematologic toxicityLeukemia Group B experienceLeukemia/myelodysplastic syndromeNode-positive breast cancerComparison of cyclophosphamideNode-positive patientsPercent of patientsHealthy older patientsStrict eligibility criteriaRisk of toxicityCALGB 9741Patients 65Elderly patientsOverall survival
2006
Toxicity of older and younger patients (pts) treated (Rx) with intensive adjuvant chemotherapy (Cx) for node-positive (N+) breast cancer (BC): The CALGB experience
Muss H, Berry D, Cirrincione C, Budman D, Henderson I, Citron M, Norton L, Winer E, Hudis C. Toxicity of older and younger patients (pts) treated (Rx) with intensive adjuvant chemotherapy (Cx) for node-positive (N+) breast cancer (BC): The CALGB experience. Journal Of Clinical Oncology 2006, 24: 559-559. DOI: 10.1200/jco.2006.24.18_suppl.559.Peer-Reviewed Original ResearchAML/MDSNon-hematologic toxicitiesBreast cancerOlder ptsYounger ptsNode-positive breast cancerIntensive adjuvant chemotherapyAge-adjusted ratesStrict eligibility criteriaAdjuvant chemotherapyHematologic toxicityMajor toxicitySurvival benefitYounger patientsCardiac deathClinical trialsGrade 3Eligibility criteriaHigh incidenceNormal populationIncidenceDeathTrialsRegimensSignificant differences
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
2004
Failure of Higher-Dose Paclitaxel to Improve Outcome in Patients With Metastatic Breast Cancer: Cancer and Leukemia Group B Trial 9342
Winer EP, Berry DA, Woolf S, Duggan D, Kornblith A, Harris LN, Michaelson RA, Kirshner JA, Fleming GF, Perry MC, Graham ML, Sharp SA, Keresztes R, Henderson IC, Hudis C, Muss H, Norton L. Failure of Higher-Dose Paclitaxel to Improve Outcome in Patients With Metastatic Breast Cancer: Cancer and Leukemia Group B Trial 9342. Journal Of Clinical Oncology 2004, 22: 2061-2068. PMID: 15169793, DOI: 10.1200/jco.2004.08.048.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerBreast cancerQuality of lifeOptimal doseResponse rateSignificant dose-response relationshipHigh-dose armPrior chemotherapy regimensHigh-dose therapySymptom assessment questionnaireCycles of treatmentSelf-administered qualitySignificant differencesDose-response relationshipChemotherapy regimensDose therapyHematologic toxicityDose armAssessment QuestionnaireHigh dosesMultivariate analysisSignificant associationInfusionCancerRegimens