2020
Road Map to Safe and Well-Designed De-escalation Trials of Systemic Adjuvant Therapy for Solid Tumors.
Piccart MJ, Hilbers FS, Bliss JM, Caballero C, Frank ES, Renault P, Naït Kaoudjt R, Schumacher E, Spears PA, Regan MM, Gelber RD, Davidson NE, Norton L, Winer EP. Road Map to Safe and Well-Designed De-escalation Trials of Systemic Adjuvant Therapy for Solid Tumors. Journal Of Clinical Oncology 2020, 38: 4120-4129. PMID: 33052755, DOI: 10.1200/jco.20.01382.Peer-Reviewed Original ResearchConceptsDe-escalation trialsNorth American Breast Cancer GroupBreast International GroupTreatment de-escalation trialsSystemic adjuvant therapySystemic adjuvant treatmentBreast cancer groupNoninferiority trial designAdjuvant trialsAdjuvant therapyAdjuvant treatmentCancer groupDifferent cancer typesPatient insightPatient's perspectiveEffective treatmentConsensus articleTrial designSolid tumorsField of cancerEnd pointFinancial toxicityCancer typesTrialsAdverse effects
2016
Accrual of Older Patients With Breast Cancer to Alliance Systemic Therapy Trials Over Time: Protocol A151527
Freedman RA, Foster JC, Seisler DK, Lafky JM, Muss HB, Cohen HJ, Mandelblatt J, Winer EP, Hudis CA, Partridge AH, Carey LA, Cirrincione C, Moreno-Aspitia A, Kimmick G, Jatoi A, Hurria A. Accrual of Older Patients With Breast Cancer to Alliance Systemic Therapy Trials Over Time: Protocol A151527. Journal Of Clinical Oncology 2016, 35: 421-431. PMID: 27992272, PMCID: PMC5455700, DOI: 10.1200/jco.2016.69.4182.Peer-Reviewed Original ResearchConceptsOlder patientsMetastatic trialsAdjuvant trialsBreast cancerHormone receptor-negative tumorsBreast cancer treatment trialConclusion Older patientsSystemic therapy trialsReceptor-negative tumorsBreast cancer trialsCancer treatment trialsYears of ageAccrual challengesNeoadjuvant trialsAdjuvant studiesPatient ageTherapy cessationLymph nodesTherapeutic trialsTreatment cessationTumor sizeDisease characteristicsPatient populationTreatment trialsCancer trials
2014
Trastuzumab Plus Adjuvant Chemotherapy for Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: Planned Joint Analysis of Overall Survival From NSABP B-31 and NCCTG N9831
Perez EA, Romond EH, Suman VJ, Jeong JH, Sledge G, Geyer CE, Martino S, Rastogi P, Gralow J, Swain SM, Winer EP, Colon-Otero G, Davidson NE, Mamounas E, Zujewski JA, Wolmark N. Trastuzumab Plus Adjuvant Chemotherapy for Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: Planned Joint Analysis of Overall Survival From NSABP B-31 and NCCTG N9831. Journal Of Clinical Oncology 2014, 32: 3744-3752. PMID: 25332249, PMCID: PMC4226805, DOI: 10.1200/jco.2014.55.5730.Peer-Reviewed Original ResearchConceptsHuman epidermal growth factor receptorOverall survivalBreast cancerEpidermal growth factor receptorGrowth factor receptorNCCTG N9831NSABP BEarly-Stage Human Epidermal Growth Factor ReceptorHER2-positive operable breast cancerNational Surgical Adjuvant BreastLarge adjuvant trialsOperable breast cancerAddition of trastuzumabAnti-HER2 agentsFactor receptorSurvival end pointsBreast cancer resultsDFS ratesOverall DFSAdjuvant BreastAdjuvant chemotherapyAdjuvant trialsOS ratesMedian timePatient subgroupsImpact 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
2013
Effect of Age on Breast Cancer Outcomes in Women With Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: Results From a Herceptin Adjuvant Trial
Partridge AH, Gelber S, Piccart-Gebhart MJ, Focant F, Scullion M, Holmes E, Winer EP, Gelber RD. Effect of Age on Breast Cancer Outcomes in Women With Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: Results From a Herceptin Adjuvant Trial. Journal Of Clinical Oncology 2013, 31: 2692-8. PMID: 23752109, DOI: 10.1200/jco.2012.44.1956.Peer-Reviewed Original ResearchConceptsHazard ratioPredictive factorsBreast cancerEarly-stage HER2-positive breast cancerHuman epidermal growth factor receptor 2 (HER2) statusEpidermal growth factor receptor 2 statusOverall survival hazard ratioHER2-positive breast cancerHuman epidermal growth factor receptorHerceptin Adjuvant (HERA) trialYear of trastuzumabIndependent risk factorSurvival hazard ratioAnti-HER2 treatmentBreast cancer outcomesTrial of womenBreast cancer recurrenceSeparate Cox modelsImpact of ageEpidermal growth factor receptorPrediction of benefitAdjuvant trialsGrowth factor receptorHERA trialMedian follow
2011
Will preoperative trials change future clinical practice?
Lim E, Winer E. Will preoperative trials change future clinical practice? Clinical Investigation 2011, 1: 59-73. DOI: 10.4155/cli.10.3.Peer-Reviewed Original ResearchPreoperative systemic therapySystemic therapyBreast cancerOperable breast cancerManagement of patientsPST trialsPost-treatment tissuesFuture clinical practiceAdjuvant trialsBreast cancePredictive biomarkersPreoperative trialBiomarker discovery programsBiologic mechanismsClinical practiceTherapyVivo studiesTrialsOff-target effectsIdentification of pathwaysCorrelative studiesDrug developmentCancerPatientsDiscovery programs