2022
Treatment discontinuation, patient-reported toxicities and quality-of-life by age following trastuzumab emtansine or paclitaxel/trastuzumab (ATEMPT)
Sella T, Zheng Y, Tayob N, Ruddy K, Freedman R, Dang C, Yardley D, Isakoff S, Valero V, DeMeo M, Burstein H, Winer E, Wolff A, Krop I, Partridge A, Tolaney S. Treatment discontinuation, patient-reported toxicities and quality-of-life by age following trastuzumab emtansine or paclitaxel/trastuzumab (ATEMPT). Npj Breast Cancer 2022, 8: 127. PMID: 36450763, PMCID: PMC9712612, DOI: 10.1038/s41523-022-00495-x.Peer-Reviewed Original ResearchHER2-positive breast cancerPatient-reported toxicityPatient-reported outcomesT-DM1Treatment discontinuationTrastuzumab emtansineBreast cancerStage I HER2-positive breast cancerAdjuvant trastuzumab emtansineExcellent disease outcomesLess activity impairmentPaclitaxel/trastuzumabSocial/familyPositive breast cancerSuperior QoLOlder patientsTreatment toleranceTreatment armsTreatment regimensEligible participantsGlobal QoLTherapy optionsActivity impairmentMultivariable modelDisease outcome
2021
SYST-06. PHASE II TRIAL OF PAXALISIB (GDC-0084) IN COMBINATION WITH TRASTUZUMAB FOR PATIENTS WITH HER2-POSITIVE BREAST CANCER BRAIN METASTASES (BCBM)
Leone J, Tayob N, Pereslete A, Ligibel J, Parsons H, Bi W, Zhao J, Winer E, Lin N. SYST-06. PHASE II TRIAL OF PAXALISIB (GDC-0084) IN COMBINATION WITH TRASTUZUMAB FOR PATIENTS WITH HER2-POSITIVE BREAST CANCER BRAIN METASTASES (BCBM). Neuro-Oncology Advances 2021, 3: iv9-iv9. DOI: 10.1093/noajnl/vdab112.034.Peer-Reviewed Original ResearchBreast cancer brain metastasesObjective response rateCohort BCohort ACNS metastasesPrimary endpointHER2-positive breast cancer brain metastasesNeuro-Oncology Brain Metastases criteriaCentral nervous system metastasesHER2-positive breast cancerPatient-derived xenografts (PDX) modelsPhase II cohortNervous system metastasesPhase II studyCancer brain metastasesPhase II trialPI3K/Akt/mTORPatient-reported outcomesPI3KBrain-penetrant inhibitorAkt/mTORMetastasis (TNM) criteriaBrain metastasesII trialMetastasis resectionAdjuvant Trastuzumab Emtansine Versus Paclitaxel in Combination With Trastuzumab for Stage I HER2-Positive Breast Cancer (ATEMPT): A Randomized Clinical Trial
Tolaney SM, Tayob N, Dang C, Yardley DA, Isakoff SJ, Valero V, Faggen M, Mulvey T, Bose R, Hu J, Weckstein D, Wolff AC, Reeder-Hayes K, Rugo HS, Ramaswamy B, Zuckerman D, Hart L, Gadi VK, Constantine M, Cheng K, Briccetti F, Schneider B, Garrett AM, Marcom K, Albain K, DeFusco P, Tung N, Ardman B, Nanda R, Jankowitz RC, Rimawi M, Abramson V, Pohlmann PR, Van Poznak C, Forero-Torres A, Liu M, Ruddy K, Zheng Y, Rosenberg SM, Gelber RD, Trippa L, Barry W, DeMeo M, Burstein H, Partridge A, Winer EP, Krop I. Adjuvant Trastuzumab Emtansine Versus Paclitaxel in Combination With Trastuzumab for Stage I HER2-Positive Breast Cancer (ATEMPT): A Randomized Clinical Trial. Journal Of Clinical Oncology 2021, 39: 2375-2385. PMID: 34077270, DOI: 10.1200/jco.20.03398.Peer-Reviewed Original ResearchConceptsInvasive disease-free survivalT-DM1Breast cancerStage IStage I HER2-positive breast cancerHER2-positive breast cancerHuman epidermal growth factor receptorAdjuvant T-DM1Co-primary objectivesDisease-free survivalPatient-reported outcomesEpidermal growth factor receptorGrowth factor receptorProtocol therapyAnalysis populationTrastuzumab emtansineClinical trialsRelevant toxicityPatientsFactor receptorLess toxicityWeeksTrastuzumabCancerPaclitaxelUpdated 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 points
2020
Primary analysis of KAITLIN: A phase III study of trastuzumab emtansine (T-DM1) + pertuzumab versus trastuzumab + pertuzumab + taxane, after anthracyclines as adjuvant therapy for high-risk HER2-positive early breast cancer (EBC).
Harbeck N, Im S, Barrios C, Bonnefoi H, Gralow J, Toi M, Ellis P, Gianni L, Swain S, Im Y, De Laurentiis M, Nowecki Z, Shah J, Boulet T, Liu H, Macharia H, Trask P, Song C, Winer E, Krop I. Primary analysis of KAITLIN: A phase III study of trastuzumab emtansine (T-DM1) + pertuzumab versus trastuzumab + pertuzumab + taxane, after anthracyclines as adjuvant therapy for high-risk HER2-positive early breast cancer (EBC). Journal Of Clinical Oncology 2020, 38: 500-500. DOI: 10.1200/jco.2020.38.15_suppl.500.Peer-Reviewed Original ResearchHER2-positive early breast cancerInvasive disease-free survivalEarly breast cancerPatient-reported outcomesCo-primary endpointsStandard of careT-DM1ITT populationOverall survivalAnthracycline-based chemotherapyOpen-label studyDisease-free survivalPhase III studyWeeks of surgeryHigh-risk populationChemotherapy-associated toxicityAdjuvant taxanesConcurrent trastuzumabEndocrine therapySecondary endpointsAdjuvant radiotherapyAdjuvant therapyIII studyNodal statusMore patientsPatient-reported outcomes from the phase III IMpassion130 trial of atezolizumab plus nab-paclitaxel in metastatic triple-negative breast cancer
Adams S, Diéras V, Barrios CH, Winer EP, Schneeweiss A, Iwata H, Loi S, Patel S, Henschel V, Chui SY, Rugo HS, Emens LA, Schmid P. Patient-reported outcomes from the phase III IMpassion130 trial of atezolizumab plus nab-paclitaxel in metastatic triple-negative breast cancer. Annals Of Oncology 2020, 31: 582-589. PMID: 32178964, DOI: 10.1016/j.annonc.2020.02.003.Peer-Reviewed Original ResearchConceptsMetastatic triple-negative breast cancerPatient-reported outcomesTriple-negative breast cancerFirst-line treatmentHealth-related qualityNab-paclitaxelPD-L1Treatment symptomsBreast cancerBaseline scoresDay 1Progression-free survival benefitPatients' health-related qualityEnd pointBreast cancer moduleExploratory end pointsSecondary end pointsTreatment-related symptomsEnd of treatmentKey treatment goalMean baseline scoreCourse of treatmentITT patientsMeaningful worseningMTNBC patients
2019
Personalized Management of Chemotherapy‐Induced Peripheral Neuropathy Based on a Patient Reported Outcome: CALGB 40502 (Alliance)
Sharma MR, Mehrotra S, Gray E, Wu K, Barry WT, Hudis C, Winer EP, Lyss AP, Toppmeyer DL, Moreno‐Aspitia A, Lad TE, Velasco M, Overmoyer B, Rugo HS, Ratain MJ, Gobburu JV. Personalized Management of Chemotherapy‐Induced Peripheral Neuropathy Based on a Patient Reported Outcome: CALGB 40502 (Alliance). The Journal Of Clinical Pharmacology 2019, 60: 444-452. PMID: 31802506, PMCID: PMC7064382, DOI: 10.1002/jcph.1559.Peer-Reviewed Original ResearchMeSH KeywordsAlbuminsAlgorithmsAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsComputer SimulationDrug Administration ScheduleDrug TaperingEpothilonesFemaleHumansModels, BiologicalPaclitaxelPatient Reported Outcome MeasuresPeripheral Nervous System DiseasesPrecision MedicineConceptsDose-adjustment algorithmPatient-reported outcome dataEarly time pointsNeuropathy scoreDose adjustmentNanoparticle albuminIndividual patientsTime pointsOutcome dataChemotherapy-induced peripheral neuropathyRandomized phase III trialFirst-line chemotherapyMetastatic breast cancerPhase III trialsPatient-reported outcomesTRLS-03. PHASE II TRIAL OF GDC-0084 IN COMBINATION WITH TRASTUZUMAB FOR PATIENTS WITH HER2-POSITIVE BREAST CANCER BRAIN METASTASES (BCBM)
Leone J, Trippa L, Milisits L, Andrews C, Ligibel J, Parsons H, Bi W, Zhao J, Winer E, Lin N. TRLS-03. PHASE II TRIAL OF GDC-0084 IN COMBINATION WITH TRASTUZUMAB FOR PATIENTS WITH HER2-POSITIVE BREAST CANCER BRAIN METASTASES (BCBM). Neuro-Oncology Advances 2019, 1: i9-i9. PMCID: PMC7213424, DOI: 10.1093/noajnl/vdz014.036.Peer-Reviewed Original ResearchBreast cancer brain metastasesObjective response rateCohort BCohort ACNS metastasesPrimary endpointHER2-positive breast cancer brain metastasesNeuro-Oncology Brain Metastases criteriaCentral nervous system metastasesHER2-positive breast cancerPatient-derived xenografts (PDX) modelsPhase II cohortNervous system metastasesPhase II studyCancer brain metastasesPhase II trialPI3K/Akt/mTORPatient-reported outcomesPI3KBrain-penetrant inhibitorAkt/mTORCombination of GDCMetastasis (TNM) criteriaBrain metastasesII trialPatient-reported outcomes (PROs) from the phase III IMpassion130 trial of atezolizumab (atezo) plus nabpaclitaxel (nP) in metastatic triple-negative breast cancer (mTNBC).
Adams S, Dieras V, Barrios C, Winer E, Schneeweiss A, Iwata H, Loi S, Patel S, Henschel V, Chui S, Rugo H, Emens L, Schmid P. Patient-reported outcomes (PROs) from the phase III IMpassion130 trial of atezolizumab (atezo) plus nabpaclitaxel (nP) in metastatic triple-negative breast cancer (mTNBC). Journal Of Clinical Oncology 2019, 37: 1067-1067. DOI: 10.1200/jco.2019.37.15_suppl.1067.Peer-Reviewed Original ResearchMetastatic triple-negative breast cancerPatient-reported outcomesPD-L1Role functionClinical benefitPhysical functionDay 1Triple-negative breast cancerBreast cancer moduleEORTC QLC-C30Overall clinical benefitEnd of treatmentExploratory endpointsSecondary endpointsCancer ModuleDisease progressionBreast cancerHRQoLPRO dataMedian TTDAtezoBL scoreOS improvementSymptomsPhase III
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 1Associations among survivorship care plans, experiences of survivorship care, and functioning in older breast cancer survivors: CALGB/Alliance 369901
Faul LA, Luta G, Sheppard V, Isaacs C, Cohen HJ, Muss HB, Yung R, Clapp JD, Winer E, Hudis C, Tallarico M, Wang J, Barry WT, Mandelblatt JS. Associations among survivorship care plans, experiences of survivorship care, and functioning in older breast cancer survivors: CALGB/Alliance 369901. Journal Of Cancer Survivorship 2014, 8: 627-637. PMID: 24917307, PMCID: PMC4386650, DOI: 10.1007/s11764-014-0371-5.Peer-Reviewed Original ResearchConceptsOlder breast cancer survivorsSurvivorship care plansBreast cancer survivorsCare plansCancer survivorsSCP receiptSurvivorship careOlder survivorsBreast cancer followCooperative group sitesNonmetastatic breast cancerPatient-reported outcomesCancer followSymptom burdenComorbid conditionsRecurrence surveillanceCancer patientsCancer sequelaePrimary careMethodsThree hundredBreast cancerCancer worryLower oddsOlder womenTelephone interviews