2016
Variation in the use of granulocyte-colony stimulating factor for dose dense paclitaxel: A single institution retrospective study
Barroso-Sousa R, Paes FR, Vaz-Luis I, Batista RB, Costa RB, Losk K, Camuso K, Metzger-Filho O, Hughes ME, Bunnell CA, Golshan M, Winer EP, Lin NU. Variation in the use of granulocyte-colony stimulating factor for dose dense paclitaxel: A single institution retrospective study. The Breast 2016, 30: 136-140. PMID: 27721193, DOI: 10.1016/j.breast.2016.09.013.Peer-Reviewed Original ResearchMeSH KeywordsAdultAntineoplastic Agents, PhytogenicAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCase-Control StudiesChemotherapy, AdjuvantCyclophosphamideDoxorubicinFemaleGranulocyte Colony-Stimulating FactorHumansMiddle AgedNeutropeniaPaclitaxelPractice Patterns, Physicians'Retrospective StudiesYoung AdultConceptsGranulocyte-colony stimulating factorDose-dense paclitaxelTreatment delayGroup 1High baseline absolute neutrophil countBaseline absolute neutrophil countSingle-institution retrospective studyDana-Farber Cancer InstituteStimulating factorRoutine G-CSFPercent of patientsRetrospective cohort studyAbsolute neutrophil countMajority of patientsAdverse eventsCohort studyNeutrophil countTreatment cessationProspective studyRetrospective studyT therapyBreast cancerGroup 2PatientsCancer Institute
2014
Polygenic inheritance of paclitaxel-induced sensory peripheral neuropathy driven by axon outgrowth gene sets in CALGB 40101 (Alliance)
Chhibber A, Mefford J, Stahl EA, Pendergrass SA, Baldwin RM, Owzar K, Li M, Winer EP, Hudis CA, Zembutsu H, Kubo M, Nakamura Y, McLeod HL, Ratain MJ, Shulman LN, Ritchie MD, Plenge RM, Witte JS, Kroetz DL. Polygenic inheritance of paclitaxel-induced sensory peripheral neuropathy driven by axon outgrowth gene sets in CALGB 40101 (Alliance). The Pharmacogenomics Journal 2014, 14: 336-342. PMID: 24513692, PMCID: PMC4111770, DOI: 10.1038/tpj.2014.2.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic Agents, PhytogenicAxonsBreast NeoplasmsFemaleHumansMultifactorial InheritancePaclitaxelPeripheral Nervous System DiseasesPolymorphism, Single NucleotideSensory Receptor CellsConceptsSensory peripheral neuropathyPaclitaxel-induced peripheral neuropathyPeripheral neuropathyCALGB 40101Common dose-limiting toxicityPhase III clinical trialsPaclitaxel-induced neuropathyDose-limiting toxicityAxon outgrowthPaclitaxel armAdjuvant therapyAdverse eventsSusceptible patientsRisk factorsClinical trialsBreast cancerNeuropathyPaclitaxel treatmentClinical decisionPatientsPatient informationMaximum gradeHeritable componentMost individualsTreatment
2013
Integration of Cell Line and Clinical Trial Genome-Wide Analyses Supports a Polygenic Architecture of Paclitaxel-Induced Sensory Peripheral Neuropathy
Wheeler HE, Gamazon ER, Wing C, Njiaju UO, Njoku C, Baldwin RM, Owzar K, Jiang C, Watson D, Shterev I, Kubo M, Zembutsu H, Winer EP, Hudis CA, Shulman LN, Nakamura Y, Ratain MJ, Kroetz DL, B F, Cox NJ, Dolan ME. Integration of Cell Line and Clinical Trial Genome-Wide Analyses Supports a Polygenic Architecture of Paclitaxel-Induced Sensory Peripheral Neuropathy. Clinical Cancer Research 2013, 19: 491-499. PMID: 23204130, PMCID: PMC3549006, DOI: 10.1158/1078-0432.ccr-12-2618.Peer-Reviewed Original ResearchConceptsExpression quantitative trait lociSingle nucleotide polymorphismsPolygenic architectureGenome-wide association study resultsLymphoblastoid cell line (LCL) modelGenome-wide analysisSignificant enrichmentQuantitative trait lociRegulatory factor X (RFX) familyAssociation study resultsRelevant genetic variantsGWAS resultsTrait lociAllelic directionCell line modelsRelated traitsHapMap projectEnrichment resultsPaclitaxel-induced cytotoxicityCellular modelReduced neurite outgrowthGenetic variantsRFX2Neurite outgrowthCell lines
2012
A Genome-Wide Association Study Identifies Novel Loci for Paclitaxel-Induced Sensory Peripheral Neuropathy in CALGB 40101
Baldwin RM, Owzar K, Zembutsu H, Chhibber A, Kubo M, Jiang C, Watson D, Eclov RJ, Mefford J, McLeod HL, Friedman PN, Hudis CA, Winer EP, Jorgenson EM, Witte JS, Shulman LN, Nakamura Y, Ratain MJ, Kroetz DL. A Genome-Wide Association Study Identifies Novel Loci for Paclitaxel-Induced Sensory Peripheral Neuropathy in CALGB 40101. Clinical Cancer Research 2012, 18: 5099-5109. PMID: 22843789, PMCID: PMC3445665, DOI: 10.1158/1078-0432.ccr-12-1590.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Agents, PhytogenicBreast NeoplasmsFemaleGenetic LociGenetic Predisposition to DiseaseGenome-Wide Association StudyGenotypeHumansIncidenceMicrofilament ProteinsMiddle AgedPaclitaxelPeripheral Nervous System DiseasesPolymorphism, Single NucleotideReceptor, EphA5Sensory Receptor CellsConceptsSensory peripheral neuropathyWide association studyPeripheral neuropathyCALGB 40101Genome-wide association study identifies novel lociAssociation studiesPrimary breast cancerIdentification of patientsNovel genetic markersGenetic risk factorsAfrican American subjectsSingle nucleotide polymorphismsAdditional EuropeanNovel lociPaclitaxel armAdditional genesGenetic variationPaclitaxel therapyClinical managementRisk factorsBreast cancerDiscovery cohortPharmacogenetic analysisNeuropathyGenetic markers
2008
Racial Differences in Clinical Outcomes From Metastatic Breast Cancer: A Pooled Analysis of CALGB 9342 and 9840—Cancer and Leukemia Group B
Polite BN, Cirrincione C, Fleming GF, Berry DA, Seidman A, Muss H, Norton L, Shapiro C, Bakri K, Marcom K, Lake D, Schwartz JH, Hudis C, Winer EP. Racial Differences in Clinical Outcomes From Metastatic Breast Cancer: A Pooled Analysis of CALGB 9342 and 9840—Cancer and Leukemia Group B. Journal Of Clinical Oncology 2008, 26: 2659-2665. PMID: 18509177, PMCID: PMC4830463, DOI: 10.1200/jco.2007.13.9782.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerHazard of deathTreatment failureBreast cancerOverall survivalClinical outcomesLeukemia Group B trialAfrican AmericansLeukemia Group BMedian overall survivalTreatment-related toxicityObserved survival differencesTime of presentationAfrican American patientsRacial differencesOverall responseAfrican American womenLarge cooperative groupsMetastatic settingProtocol treatmentPrognostic factorsStudy cohortSubsequent therapyShorter survivalPooled analysis
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 analysisCyclophosphamide
2006
Molecular subtypes of breast cancer in relation to paclitaxel response and outcomes in women with metastatic disease: results from CALGB 9342
Harris LN, Broadwater G, Lin NU, Miron A, Schnitt SJ, Cowan D, Lara J, Bleiweiss I, Berry D, Ellis M, Hayes DF, Winer EP, Dressler L. Molecular subtypes of breast cancer in relation to paclitaxel response and outcomes in women with metastatic disease: results from CALGB 9342. Breast Cancer Research 2006, 8: r66. PMID: 17129383, PMCID: PMC1797029, DOI: 10.1186/bcr1622.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerTriple-negative tumorsOverall survivalBreast cancerP53 statusNegative tumorsHER2 statusHormone receptorsHormone receptor statusShorter median timeDoses of paclitaxelLonger overall survivalHER2-positive tumorsAfrican American patientsHormone receptor expressionPrimary tumor tissuesAdvanced diseaseMetastatic diseaseShorter OSReceptor statusMedian timeTreatment failureShorter survivalCaucasian patientsPathology reportsInterleukin-6, multidrug resistance protein-1 expression and response to paclitaxel in women with metastatic breast cancer: results of cancer and leukemia group B trial 159806
Rincon M, Broadwater G, Harris L, Crocker A, Weaver D, Dressler L, Berry D, Sutton L, Michaelson R, Messino M, Kirshner J, Fleming G, Winer E, Hudis C, Appel S, Norton L, Muss H, for the Cancer and Leukemia Group B. Interleukin-6, multidrug resistance protein-1 expression and response to paclitaxel in women with metastatic breast cancer: results of cancer and leukemia group B trial 159806. Breast Cancer Research And Treatment 2006, 100: 301-308. PMID: 16773437, DOI: 10.1007/s10549-006-9251-7.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerInterleukin-6Breast cancerP-glycoproteinPgp expressionMultidrug resistance protein-1 expressionSingle-agent paclitaxelElevated serum levelsBreast cancer patientsBreast cancer cell linesProtein-1 expressionResult of cancerMulti-drug resistanceCancer cell linesClinical characteristicsOverall survivalPartial responseSerum levelsTreatment armsWorse prognosisPredictive factorsCancer patientsPredictive markerIHC expressionPaclitaxel sensitivity
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
2000
Letter to the Editor
Patridge A, Winer E. Letter to the Editor. Clinical Breast Cancer 2000, 1: 164-165. PMID: 11899655, DOI: 10.1016/s1526-8209(11)70117-3.Peer-Reviewed Original ResearchDocetaxel administered on a weekly basis for metastatic breast cancer.
Burstein H, Manola J, Younger J, Parker L, Bunnell C, Scheib R, Matulonis U, Garber J, Clarke K, Shulman L, Winer E. Docetaxel administered on a weekly basis for metastatic breast cancer. Journal Of Clinical Oncology 2000, 18: 1212-9. PMID: 10715290, DOI: 10.1200/jco.2000.18.6.1212.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Agents, PhytogenicBreast NeoplasmsDocetaxelDrug Administration ScheduleFemaleHumansMiddle AgedNeoplasm MetastasisPaclitaxelSurvival AnalysisTaxoidsConceptsMetastatic breast cancerWeekly docetaxelBreast cancerPrior chemotherapyCumulative docetaxel doseGrade 4 toxicityGrade 3 toxicityPercent of patientsWeeks of therapySide effect profileSubgroup of patientsSimilar response ratesAdjuvant chemotherapyDocetaxel doseStable diseasePartial responseComplete responseTreat analysisTreatment breaksEffect profileFluid retentionPatient preferencesDisease progressionRepetitive dosingDose reduction
1999
Vinorelbine as first-line chemotherapy for advanced breast cancer in women 60 years of age or older
Vogel C, O’Rourke M, Winer E, Hochster H, Chang A, Adamkiewicz B, White R, McGuirt C. Vinorelbine as first-line chemotherapy for advanced breast cancer in women 60 years of age or older. Annals Of Oncology 1999, 10: 397-402. PMID: 10370781, DOI: 10.1023/a:1008364222793.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overAgingAntineoplastic Agents, PhytogenicBreast NeoplasmsDisease-Free SurvivalDose-Response Relationship, DrugDrug Administration ScheduleFemaleFollow-Up StudiesHumansInfusions, IntravenousMiddle AgedProspective StudiesSeverity of Illness IndexTreatment OutcomeVinblastineVinorelbineConceptsAdvanced breast cancerDose-limiting toxicityBreast cancerSide effectsNonhematologic toxicityElderly patientsMeasurable advanced breast cancerMajor dose-limiting toxicityActivity of vinorelbineMedian dose intensityFirst-line chemotherapyObjective response rateFirst-line therapyPhase II trialSubjective side effectsInjection site reactionsWomen 60 yearsGastrointestinal side effectsGeneralized painIntravenous vinorelbinePrior chemotherapyAbdominal painChest painII trialCytotoxic chemotherapyInability 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