2019
First-line (1L) ribociclib (RIB) plus letrozole (LET) for postmenopausal women with hormone receptor-positive (HR+), HER2- advanced breast cancer (ABC): MONALEESA-2 long-term safety results.
O'Shaughnessy J, Campone M, Andre F, Nusch A, Grischke E, Villanueva C, Marschner N, Winer E, Paluch-Shimon S, Rodriguez-Lorenc K, Hilliard A, Le Gac F, Ridolfi A, Hortobagyi G. First-line (1L) ribociclib (RIB) plus letrozole (LET) for postmenopausal women with hormone receptor-positive (HR+), HER2- advanced breast cancer (ABC): MONALEESA-2 long-term safety results. Journal Of Clinical Oncology 2019, 37: 1078-1078. DOI: 10.1200/jco.2019.37.15_suppl.1078.Peer-Reviewed Original ResearchGrade adverse eventsAdverse eventsLET armMedian durationHER2- advanced breast cancerLong-term safety resultsLong-term safety dataFirst-line ribociclibMONALEESA-2 studyCommon adverse eventsMo of exposureMONALEESA-2Data cutoffGI disordersPostmenopausal womenSafety profileProlonged QTQT intervalBreast cancerSafety dataSafety resultsSudden deathDose reductionPlaceboCommon reasonAvoiding 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
2012
Phase I, open-label study of olaparib plus cisplatin in patients with advanced solid tumors.
Balmaña J, Tung N, Isakoff S, Graña B, Ryan P, Rafi R, Tracy M, Winer E, Baselga J, Garber J. Phase I, open-label study of olaparib plus cisplatin in patients with advanced solid tumors. Journal Of Clinical Oncology 2012, 30: 1009-1009. DOI: 10.1200/jco.2012.30.15_suppl.1009.Peer-Reviewed Original ResearchAdvanced solid tumorsHematologic AEsEvaluable ptsMonotherapy phaseDose reductionSolid tumorsAntitumor activityOpen-label studyDose-limiting toxicityCisplatin-related toxicityDose-finding studyDrug-related deathsOral PARP inhibitorLong respondersOlaparib capsulesNeoadjuvant settingPrior regimensStable diseaseDurable responsesObjective responsePeritoneal cancerTherapy cyclesMedian numberBreast cancerTreatment cycles
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
Tolerability of and adherence to combination oral therapy with gefitinib and capecitabine in metastatic breast cancer
Mayer EL, Partridge AH, Harris LN, Gelman RS, Schumer ST, Burstein HJ, Winer EP. Tolerability of and adherence to combination oral therapy with gefitinib and capecitabine in metastatic breast cancer. Breast Cancer Research And Treatment 2009, 117: 615-623. PMID: 19294501, PMCID: PMC4578795, DOI: 10.1007/s10549-009-0366-5.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerStable diseaseValidation cohortBreast cancerSequential cohortsPhase ICombination oral therapyOral antineoplastic therapyDays on/7Primary endpointSecondary endpointsOral therapyPartial responseAntineoplastic therapySerious toxicityDose reductionDrug dosesM2/dayCohortSignificant toxicityPatientsTherapyMTDCycle 1CapecitabineDose-dense (DD) doxorubicin and cyclophosphamide (AC) followed by weekly paclitaxel (P) with trastuzumab (T) and lapatinib (L) in HER2/neu-positive breast cancer is not feasible due to excessive diarrhea: updated results.
Dang C, Lin N, Moy B, Come S, Lake D, Theodoulou M, Troso-Sandoval T, Dickler M, Gorsky M, D'Andrea G, Modi S, Seidman A, Drullinsky P, Partridge A, Schapira L, Wulf G, Gilewski T, Atieh D, Mayer E, Isakoff S, Sugarman S, Fornier M, Traina T, Bromberg J, Currie V, Robson M, Burstein H, Overmoyer B, Ryan P, Kuter I, Younger J, Schumer S, Tung N, Zarwan C, Schnipper L, Chen C, Winer E, Norton L, Hudis C. Dose-dense (DD) doxorubicin and cyclophosphamide (AC) followed by weekly paclitaxel (P) with trastuzumab (T) and lapatinib (L) in HER2/neu-positive breast cancer is not feasible due to excessive diarrhea: updated results. Cancer Research 2009, 69: 2108. DOI: 10.1158/0008-5472.sabcs-2108.Peer-Reviewed Original ResearchDd ACHER2- BCLVEF declineDose reductionHER2/neu-positive breast cancerCongestive heart failure ratesNeu-positive breast cancerAsymptomatic LVEF declineCardiac event rateDose-dense doxorubicinHeart failure ratesDose delaysExcessive diarrheaWeekly paclitaxelMedian ageCardiac safetyMonth 2Breast cancerEvent ratesCancer ResDiarrheaPilot studyLVEFLapatinibBaseline
2007
Dose-dense nab-paclitaxel (nanoparticle albumin-bound paclitaxel) in adjuvant chemotherapy for breast cancer: A feasibility study
Burstein H, Mayer E, Peppercorn J, Parker L, Hannagan K, Moy B, Younger J, Schapira L, Wulf G, Gelman R, Winer E. Dose-dense nab-paclitaxel (nanoparticle albumin-bound paclitaxel) in adjuvant chemotherapy for breast cancer: A feasibility study. Journal Of Clinical Oncology 2007, 25: 594-594. DOI: 10.1200/jco.2007.25.18_suppl.594.Peer-Reviewed Original ResearchG-CSF supportNab-paclitaxelFebrile neutropeniaTreatment delayBreast cancerDoxorubicin/cyclophosphamideNab-paclitaxel therapyQuality of lifeDose-denseAdjuvant chemotherapyEligible patientsNeoadjuvant chemotherapyTaxane chemotherapyDose reductionFull cohortStage IPatientsNeutropeniaChemotherapyInstitutional studyPaclitaxelSignificant financial relationshipCycle 6CancerPrior studies
2006
Combination therapy with gefitinib and capecitabine in metastatic breast cancer (MBC): A phase I trial
Mayer E, Harris L, Partridge A, Gelman R, Schumer S, Comanaru R, Long M, Sampson E, Burstein H, Winer E. Combination therapy with gefitinib and capecitabine in metastatic breast cancer (MBC): A phase I trial. Journal Of Clinical Oncology 2006, 24: 10564-10564. DOI: 10.1200/jco.2006.24.18_suppl.10564.Peer-Reviewed Original ResearchMetastatic breast cancerMicroelectronic monitoring systemOral regimenValidation cohortDose reductionHand/foot syndromeSubstantial anti-tumor activityEGFR tyrosine kinase inhibitor gefitinibPhase IDose-escalation cohortsGrade 3 diarrheaGrade 4 toxicityCycles of therapyGrade 3 toxicityGrade 3/4 toxicitiesPhase I trialTyrosine kinase inhibitor gefitinibPost-therapy valuesMean numberCycle 1Lack of progressionAnti-tumor activityKinase inhibitor gefitinibEvaluable ptsUnresolved toxicity
2000
Docetaxel 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 ResearchConceptsMetastatic 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