2021
Updated Standardized Definitions for Efficacy End Points (STEEP) in Adjuvant Breast Cancer Clinical Trials: STEEP Version 2.0
Tolaney SM, Garrett-Mayer E, White J, Blinder VS, Foster JC, Amiri-Kordestani L, Hwang ES, Bliss JM, Rakovitch E, Perlmutter J, Spears PA, Frank E, Tung NM, Elias AD, Cameron D, Denduluri N, Best AF, DiLeo A, Baizer L, Butler LP, Schwartz E, Winer EP, Korde LA. Updated Standardized Definitions for Efficacy End Points (STEEP) in Adjuvant Breast Cancer Clinical Trials: STEEP Version 2.0. Journal Of Clinical Oncology 2021, 39: 2720-2731. PMID: 34003702, PMCID: PMC10166345, DOI: 10.1200/jco.20.03613.Peer-Reviewed Original ResearchConceptsEfficacy end pointPrimary end pointBreast cancer clinical trialsPrimary cancerCancer clinical trialsEnd pointStandardized definitionsRecurrence rateClinical trialsInvasive disease-free survival eventsTherapy trialsBreast cancer-free survivalDisease-free survival eventsNon-breast cancer deathPrimary efficacy end pointClinical trial end pointsPhase III breast cancer trialsCancer-free survivalSecond primary cancerTrial end pointsAdditional end pointsBreast cancer trialsLow-risk populationPatient-reported outcomesSurvival end pointsA Phase 1 Dose-Escalation Trial of Radiation Therapy and Concurrent Cisplatin for Stage II and III Triple-Negative Breast Cancer
Bellon JR, Chen YH, Rees R, Taghian AG, Wong JS, Punglia RS, Shiloh RY, Warren LEG, Krishnan MS, Phillips J, Pretz J, Jimenez R, Macausland S, Pashtan I, Andrews C, Isakoff SJ, Winer EP, Tolaney SM. A Phase 1 Dose-Escalation Trial of Radiation Therapy and Concurrent Cisplatin for Stage II and III Triple-Negative Breast Cancer. International Journal Of Radiation Oncology • Biology • Physics 2021, 111: 45-52. PMID: 33713742, DOI: 10.1016/j.ijrobp.2021.03.002.Peer-Reviewed Original ResearchConceptsTriple-negative breast cancerBreast-conserving therapyDose-limiting toxicityBCT cohortRadiation therapyConcurrent cisplatinMastectomy cohortBreast cancerEarly-stage triple-negative breast cancerThree-year disease-free survivalPhase 1 dose-escalation trialStage IILocal-regional recurrence ratePhase 2 doseAdjuvant radiation therapyDisease-free survivalDose-escalation trialPhase 1b trialDose of cisplatinHER2-positive tumorsEligible patientsUrinary infectionAdditional patientsDose escalationRecurrence rate
2018
Tailoring Adjuvant Endocrine Therapy for Premenopausal Breast Cancer
Francis PA, Pagani O, Fleming GF, Walley BA, Colleoni M, Láng I, Gómez HL, Tondini C, Ciruelos E, Burstein HJ, Bonnefoi HR, Bellet M, Martino S, Geyer CE, Goetz MP, Stearns V, Pinotti G, Puglisi F, Spazzapan S, Climent MA, Pavesi L, Ruhstaller T, Davidson NE, Coleman R, Debled M, Buchholz S, Ingle JN, Winer EP, Maibach R, Rabaglio-Poretti M, Ruepp B, Di Leo A, Coates AS, Gelber RD, Goldhirsch A, Regan MM. Tailoring Adjuvant Endocrine Therapy for Premenopausal Breast Cancer. New England Journal Of Medicine 2018, 379: 122-137. PMID: 29863451, PMCID: PMC6193457, DOI: 10.1056/nejmoa1803164.Peer-Reviewed Original ResearchConceptsTamoxifen plus ovarian suppressionTamoxifen-alone groupOvarian suppressionPremenopausal womenBreast cancerAdverse eventsOverall survivalDisease-free survival ratesOvarian Function TrialYears of tamoxifenAdjuvant endocrine therapyHigher adverse eventsReceipt of chemotherapyPremenopausal breast cancerLow recurrence rateAromatase inhibitor exemestaneUse of exemestaneSuppression groupExemestane TrialDistant recurrenceEndocrine therapyRecurrence rateGrade 3ExemestaneTamoxifen
2008
Risk Perceptions and Psychosocial Outcomes of Women With Ductal Carcinoma In Situ: Longitudinal Results From a Cohort Study
Partridge A, Adloff K, Blood E, Dees EC, Kaelin C, Golshan M, Ligibel J, de Moor JS, Weeks J, Emmons K, Winer E. Risk Perceptions and Psychosocial Outcomes of Women With Ductal Carcinoma In Situ: Longitudinal Results From a Cohort Study. Journal Of The National Cancer Institute 2008, 100: 243-251. PMID: 18270338, DOI: 10.1093/jnci/djn010.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAnxietyBreast NeoplasmsCarcinoma, Intraductal, NoninfiltratingCohort StudiesDepressionFemaleHumansLogistic ModelsLongitudinal StudiesMammographyMass ScreeningMassachusettsMiddle AgedNeoplasm Recurrence, LocalOdds RatioPredictive Value of TestsPrognosisQuality of LifeRisk AssessmentRisk FactorsConceptsLocal recurrence rateRecurrence ratePsychosocial outcomesDuctal carcinomaModerate riskCancer-related risksFavorable overall prognosisSystemic recurrence ratesBreast-conserving treatmentBreast cancer riskDCIS diagnosisCohort studyDCIS recurrenceOverall prognosisDisease recurrenceInvasive cancerDCISCancer riskPsychosocial concernsHealth behaviorsEnrollment surveySubstantial anxietyWomenInaccurate perceptionsModerate likelihood
2007
Cost-Effectiveness of Switching to Exemestane after 2 to 3 Years of Therapy with Tamoxifen in Postmenopausal Women with Early-Stage Breast Cancer
Thompson D, Taylor DC, Montoya EL, Winer EP, Jones SE, Weinstein MC. Cost-Effectiveness of Switching to Exemestane after 2 to 3 Years of Therapy with Tamoxifen in Postmenopausal Women with Early-Stage Breast Cancer. Value In Health 2007, 10: 367-376. PMID: 17888101, DOI: 10.1111/j.1524-4733.2007.00190.x.Peer-Reviewed Original ResearchMeSH KeywordsAgedAndrostadienesAntineoplastic ProtocolsAromatase InhibitorsBreast NeoplasmsCost-Benefit AnalysisDrug Administration ScheduleFemaleForecastingHumansMarkov ChainsMiddle AgedNeoplasm Recurrence, LocalPostmenopauseQuality-Adjusted Life YearsSEER ProgramSelective Estrogen Receptor ModulatorsTamoxifenConceptsIntergroup Exemestane StudyDisease-free survivalDisease-related eventsTreatment strategiesEarly-stage breast cancer patientsEarly-stage breast cancerProlongs disease-free survivalCost-effective treatment strategyIncremental cost-effectiveness ratioYears of tamoxifenYears of therapyBreast cancer patientsSEER-Medicare dataBreast cancer statusLifetime medical care costsMedical care costsCost-effectiveness ratioTamoxifen therapyPostmenopausal womenRecurrence rateCancer careCancer patientsPatient transitionsAromatase inhibitorsBreast cancer