2023
Impact of BMI in Patients With Early Hormone Receptor–Positive Breast Cancer Receiving Endocrine Therapy With or Without Palbociclib in the PALLAS Trial
Pfeiler G, Hlauschek D, Mayer E, Deutschmann C, Kacerovsky-Strobl S, Martin M, Meisel J, Zdenkowski N, Loibl S, Balic M, Park H, Prat A, Isaacs C, Bajetta E, Balko J, Bellet-Ezquerra M, Bliss J, Burstein H, Cardoso F, Fohler H, Foukakis T, Gelmon K, Goetz M, Haddad T, Iwata H, Jassem J, Lee S, Linderholm B, Los M, Mamounas E, Miller K, Morris P, Munzone E, Gal-Yam E, Ring A, Shepherd L, Singer C, Thomssen C, Tseng L, Valagussa P, Winer E, Wolff A, Zoppoli G, Machacek-Link J, Schurmans C, Huang X, Gauthier E, Fesl C, Dueck A, DeMichele A, Gnant M, Cameron D, El-Abed S, Rugo H, Steger G, Traina T, Werutsky G, Wolmark N. Impact of BMI in Patients With Early Hormone Receptor–Positive Breast Cancer Receiving Endocrine Therapy With or Without Palbociclib in the PALLAS Trial. Journal Of Clinical Oncology 2023, 41: 5118-5130. PMID: 37556775, DOI: 10.1200/jco.23.00126.Peer-Reviewed Original ResearchConceptsImpact of BMIPALLAS trialBMI categoriesHigher BMIEarly hormone receptor-positive breast cancerHormone receptor-positive breast cancerReceptor-positive breast cancerAddition of palbociclibEfficacy of palbociclibEarly treatment discontinuationRelative dose intensityTreatment discontinuation ratesDisease-free survivalSide effect profileMultivariable logistic regressionBreast cancer riskSignificant decreaseNeutropenia ratesPalbociclib armEndocrine therapyTreatment discontinuationDiscontinuation ratesDose intensityEarly discontinuationNormal weight
2022
Overall Survival with Ribociclib plus Letrozole in Advanced Breast Cancer
Hortobagyi GN, Stemmer SM, Burris HA, Yap YS, Sonke GS, Hart L, Campone M, Petrakova K, Winer EP, Janni W, Conte P, Cameron DA, André F, Arteaga CL, Zarate JP, Chakravartty A, Taran T, Le Gac F, Serra P, O'Shaughnessy J. Overall Survival with Ribociclib plus Letrozole in Advanced Breast Cancer. New England Journal Of Medicine 2022, 386: 942-950. PMID: 35263519, DOI: 10.1056/nejmoa2114663.Peer-Reviewed Original ResearchConceptsAdvanced breast cancerSignificant overall survival benefitMedian overall survivalOverall survival benefitProgression-free survivalOverall survivalBreast cancerSurvival benefitHER2-negative advanced breast cancerKey secondary end pointProtocol-specified final analysisLonger progression-free survivalHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Negative advanced breast cancerStratified log-rank testFirst-line ribociclibSecondary end pointsFirst-line therapyNew safety signalsPhase 3 trialGrowth factor receptor 2Kaplan-Meier methodLog-rank testFactor receptor 2
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
2015
SU2C Phase Ib Study of Paclitaxel and MK-2206 in Advanced Solid Tumors and Metastatic Breast Cancer
Gonzalez-Angulo AM, Krop I, Akcakanat A, Chen H, Liu S, Li Y, Culotta KS, Tarco E, Piha-Paul S, Moulder-Thompson S, Velez-Bravo V, Sahin AA, Doyle LA, Do KA, Winer EP, Mills GB, Kurzrock R, Meric-Bernstam F. SU2C Phase Ib Study of Paclitaxel and MK-2206 in Advanced Solid Tumors and Metastatic Breast Cancer. Journal Of The National Cancer Institute 2015, 107: dju493. PMID: 25688104, PMCID: PMC4342675, DOI: 10.1093/jnci/dju493.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsDrug Administration ScheduleDrug EruptionsFatigueFemaleHeterocyclic Compounds, 3-RingHumansHyperglycemiaMaleMaximum Tolerated DoseMiddle AgedNeoplasmsNeutropeniaPaclitaxelSeverity of Illness IndexTreatment OutcomeConceptsDose escalationDay 1Day 2Higher adverse eventsPhase Ib studyWeeks of therapyAdvanced solid tumorsCTCAE grade 3Metastatic breast cancerPrevious phase IPreliminary antitumor activityDose expansionStable diseaseObjective responseUnacceptable toxicityAdverse eventsMedian ageWeekly dosesClinical benefitPharmacodynamic markersSystemic exposureExcessive toxicityTumor responseGrade 3Median number
2014
Impact of the Addition of Carboplatin and/or Bevacizumab to Neoadjuvant Once-per-Week Paclitaxel Followed by Dose-Dense Doxorubicin and Cyclophosphamide on Pathologic Complete Response Rates in Stage II to III Triple-Negative Breast Cancer: CALGB 40603 (Alliance)
Sikov WM, Berry DA, Perou CM, Singh B, Cirrincione CT, Tolaney SM, Kuzma CS, Pluard TJ, Somlo G, Port ER, Golshan M, Bellon JR, Collyar D, Hahn OM, Carey LA, Hudis CA, Winer EP. Impact of the Addition of Carboplatin and/or Bevacizumab to Neoadjuvant Once-per-Week Paclitaxel Followed by Dose-Dense Doxorubicin and Cyclophosphamide on Pathologic Complete Response Rates in Stage II to III Triple-Negative Breast Cancer: CALGB 40603 (Alliance). Journal Of Clinical Oncology 2014, 33: 13-21. PMID: 25092775, PMCID: PMC4268249, DOI: 10.1200/jco.2014.57.0572.Peer-Reviewed Original ResearchMeSH KeywordsAdultAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabCarboplatinCyclophosphamideDose-Response Relationship, DrugDoxorubicinDrug Administration ScheduleFatigueFemaleHumansHypertensionMiddle AgedNeoadjuvant TherapyNeoplasm StagingNeutropeniaPaclitaxelRemission InductionThrombocytopeniaTreatment OutcomeTriple Negative Breast NeoplasmsConceptsTriple-negative breast cancerPathologic complete responseNeoadjuvant chemotherapyBreast/axillaStage IIBreast cancerPathologic complete response rateRandomized phase II trialAddition of carboplatinDose-dense doxorubicinRole of carboplatinComplete response ratePhase II trialStandard neoadjuvant chemotherapyThird of patientsAdjuvant trialsConcurrent carboplatinSkipped dosesWeek paclitaxelEarly discontinuationII trialPostoperative complicationsThromboembolic eventsDose modificationOverall survival
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
1994
Pharmacokinetic, bioavailability, and feasibility study of oral vinorelbine in patients with solid tumors.
Rowinsky EK, Noe DA, Trump DL, Winer EP, Lucas VS, Wargin WA, Hohneker JA, Lubejko B, Sartorius SE, Ettinger DS. Pharmacokinetic, bioavailability, and feasibility study of oral vinorelbine in patients with solid tumors. Journal Of Clinical Oncology 1994, 12: 1754-63. PMID: 8083697, DOI: 10.1200/jco.1994.12.9.1754.Peer-Reviewed Original ResearchConceptsMaximum-tolerated doseOral administrationOral formulationOral vinorelbineGrade 3Large first-pass effectLower starting doseSemisynthetic vinca alkaloidChronic oral administrationHepatic blood flowPhase II evaluationPharmacokinetic studyDivided-dose scheduleMaximum plasma concentrationFirst-pass effectSteady-state volumeGelatin capsulesPlasma drug dispositionPharmacologic exposuresPrincipal toxicityStarting doseDose escalationOral dosesOral doseCancer patients