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
2014
Combination cediranib and olaparib versus olaparib alone for women with recurrent platinum-sensitive ovarian cancer: a randomised phase 2 study
Liu JF, Barry WT, Birrer M, Lee JM, Buckanovich RJ, Fleming GF, Rimel B, Buss MK, Nattam S, Hurteau J, Luo W, Quy P, Whalen C, Obermayer L, Lee H, Winer EP, Kohn EC, Ivy SP, Matulonis UA. Combination cediranib and olaparib versus olaparib alone for women with recurrent platinum-sensitive ovarian cancer: a randomised phase 2 study. The Lancet Oncology 2014, 15: 1207-1214. PMID: 25218906, PMCID: PMC4294183, DOI: 10.1016/s1470-2045(14)70391-2.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Ovarian EpithelialCisplatinConfidence IntervalsDisease-Free SurvivalDose-Response Relationship, DrugDrug Administration ScheduleFemaleFollow-Up StudiesHumansKaplan-Meier EstimateMaximum Tolerated DoseMiddle AgedNeoplasm Recurrence, LocalNeoplasms, Glandular and EpithelialOvarian NeoplasmsPhthalazinesPiperazinesQuinazolinesRisk AssessmentSurvival AnalysisTreatment OutcomeConceptsProgression-free survivalRecurrent platinum-sensitive ovarian cancerPlatinum-sensitive ovarian cancerPhase 2 studyOvarian cancerOlaparib monotherapyMedian progression-free survivalGermline BRCA statusPhase 2 dosePrimary peritoneal cancerRecurrent ovarian cancerPhase 2 trialPhase 3 trialSide effect profilePhase 1 trialUS academic medical centersPatient-reported outcomesEndometrioid ovarian cancerGermline BRCA1/2 mutationsAnti-angiogenic therapyAnti-angiogenic agentsCombination of olaparibAcademic medical centerNational Cancer InstituteVEGF receptor 1
2011
PD09-05: SU2C Phase Ib Study of pan-PI3K Inhibitor BKM120 Plus Aromatase Inhibitor Letrozole in ER+/HER2− Metastatic Breast Cancer (MBC).
Mayer I, Balko J, Kuba M, Sanders M, Yap J, Li Y, Winer E, Arteaga C. PD09-05: SU2C Phase Ib Study of pan-PI3K Inhibitor BKM120 Plus Aromatase Inhibitor Letrozole in ER+/HER2− Metastatic Breast Cancer (MBC). Cancer Research 2011, 71: pd09-05-pd09-05. DOI: 10.1158/0008-5472.sabcs11-pd09-05.Peer-Reviewed Original ResearchPan-PI3K inhibitor BKM120Metastatic breast cancerFDG-PET imagingAromatase inhibitorsBreast cancerSafe side effect profilePhase Ib clinical trialAlternative administration schedulesDiagnostic tumor biopsiesGrade 3 transaminitisMost common toxicitiesPI3K-targeted therapiesSafety/tolerabilityPhase Ib studyMetastatic bone diseaseSide effect profileMonths of initiationPost-menopausal patientsWeeks of treatmentPI3K pathway inhibitionMost breast cancersAromatase inhibitor letrozoleProgression of diseasePI3K/AktCommon toxicitiesRisk of myocardial infarction, stroke, and fracture in a cohort of community-based breast cancer patients
Ligibel JA, James O’Malley A, Fisher M, Daniel GW, Winer EP, Keating NL. Risk of myocardial infarction, stroke, and fracture in a cohort of community-based breast cancer patients. Breast Cancer Research And Treatment 2011, 131: 589-597. PMID: 21881937, DOI: 10.1007/s10549-011-1754-1.Peer-Reviewed Original ResearchConceptsAdjuvant aromatase inhibitorsBreast cancer patientsCommunity-based populationCancer patientsSerious side effectsMyocardial infarctionHormonal therapyClinical trialsSide effectsOnly serious side effectTime-varying treatment variablesHealthCore Integrated Research DatabaseCox proportional hazards modelNon-trial populationSide effect profileRisk of osteoporosisProportional hazards modelHip fractureEffect profileDiagnosis codesAromatase inhibitorsHigh riskPropensity score methodsLower riskHazards model
2006
Trastuzumab and vinorelbine or taxane chemotherapy for HER2+ metastatic breast cancer: The TRAVIOTA study
Burstein H, Keshaviah A, Baron A, Hart R, Lambert-Falls R, Marcom P, Gelman R, Winer E. Trastuzumab and vinorelbine or taxane chemotherapy for HER2+ metastatic breast cancer: The TRAVIOTA study. Journal Of Clinical Oncology 2006, 24: 650-650. DOI: 10.1200/jco.2006.24.18_suppl.650.Peer-Reviewed Original ResearchMetastatic breast cancerAdvanced breast cancerBreast cancerTaxane chemotherapyResponse rateMore frequent grade 3Stage IV breast cancerComparable clinical activityFrequent grade 3Protocol-based therapySide effect profileHigh response rateDose delaysEligible patientsMeasurable diseasePrior chemotherapyVinorelbine therapyWeekly taxanesWeekly vinorelbineChemotherapy regimenPrimary endpointTaxane therapyHematological toxicityEffect profileClinical trials
2004
American Society of Clinical Oncology Technology Assessment on the Use of Aromatase Inhibitors As Adjuvant Therapy for Postmenopausal Women With Hormone Receptor–Positive Breast Cancer: Status Report 2004
Winer EP, Hudis C, Burstein HJ, Wolff AC, Pritchard KI, Ingle JN, Chlebowski RT, Gelber R, Edge SB, Gralow J, Cobleigh MA, Mamounas EP, Goldstein LJ, Whelan TJ, Powles TJ, Bryant J, Perkins C, Perotti J, Braun S, Langer AS, Browman GP, Somerfield MR. American Society of Clinical Oncology Technology Assessment on the Use of Aromatase Inhibitors As Adjuvant Therapy for Postmenopausal Women With Hormone Receptor–Positive Breast Cancer: Status Report 2004. Journal Of Clinical Oncology 2004, 23: 619-629. PMID: 15545664, DOI: 10.1200/jco.2005.09.121.Peer-Reviewed Original ResearchConceptsReceptor-positive breast cancerHormone receptor-positive breast cancerClinical Oncology technology assessmentAromatase inhibitor therapyPostmenopausal womenAromatase inhibitorsBreast cancerEndocrine therapyAdjuvant therapyInhibitor therapyMultiple large randomized trialsOptimal adjuvant hormonal therapyHormone receptor-negative tumorsOptimal endocrine therapyTreatment-related amenorrheaAdjuvant endocrine therapyAdjuvant hormonal therapyLarge randomized trialsReceptor-negative tumorsSide effect profileUse of tamoxifenAromatase inhibitor treatmentAmerican SocietyAdjuvant settingInitial therapy
2001
Side Effects of Chemotherapy and Combined Chemohormonal Therapy in Women With Early-Stage Breast Cancer
Partridge A, Burstein H, Winer E. Side Effects of Chemotherapy and Combined Chemohormonal Therapy in Women With Early-Stage Breast Cancer. JNCI Monographs 2001, 2001: 135-142. PMID: 11773307, DOI: 10.1093/oxfordjournals.jncimonographs.a003451.Peer-Reviewed Original ResearchConceptsLong-term side effectsSide effectsChemohormonal therapyAdjuvant chemotherapyShort-term side effectsEarly-stage breast cancerSide effect profileDuration of treatmentLong-term toxicityAdjuvant regimenLate complicationsEffect profileTherapy regimensBreast cancerChemotherapySpecific agentsTherapyToxic effectsPossible risksTreatmentPotential benefitsConsiderable variabilityRegimenRegimensComplications
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