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 outcomes
2017
Kinetic-Pharmacodynamic Model of Chemotherapy-Induced Peripheral Neuropathy in Patients with Metastatic Breast Cancer Treated with Paclitaxel, Nab-Paclitaxel, or Ixabepilone: CALGB 40502 (Alliance)
Mehrotra S, Sharma MR, Gray E, Wu K, Barry WT, Hudis C, Winer EP, Lyss AP, Toppmeyer DL, Moreno-Aspitia A, Lad TE, Valasco M, Overmoyer B, Rugo H, Ratain MJ, Gobburu JV. Kinetic-Pharmacodynamic Model of Chemotherapy-Induced Peripheral Neuropathy in Patients with Metastatic Breast Cancer Treated with Paclitaxel, Nab-Paclitaxel, or Ixabepilone: CALGB 40502 (Alliance). The AAPS Journal 2017, 19: 1411-1423. PMID: 28620884, PMCID: PMC5711539, DOI: 10.1208/s12248-017-0101-9.Peer-Reviewed Original ResearchConceptsChemotherapy-induced peripheral neuropathyProportion of patientsMetastatic breast cancerKinetic-pharmacodynamic modelIndirect response modelNab-paclitaxelDose modificationPeripheral neuropathyBreast cancerDrug effectsRandomized phase III trialLinear drug effectFirst-line chemotherapyPhase III trialsTime pointsDose-limiting toxicityLater time pointsEarly time pointsCALGB 40502Neurotoxicity ScaleIII trialsFunctional assessmentChemotherapeutic agentsPatientsCancer
2013
Cognitive function in older women with breast cancer treated with standard chemotherapy and capecitabine on Cancer and Leukemia Group B 49907
Freedman RA, Pitcher B, Keating NL, Ballman KV, Mandelblatt J, Kornblith AB, Kimmick GG, Hurria A, Winer EP, Hudis CA, Cohen HJ, Muss HB, for the Alliance for Clinical Trials in Oncology. Cognitive function in older women with breast cancer treated with standard chemotherapy and capecitabine on Cancer and Leukemia Group B 49907. Breast Cancer Research And Treatment 2013, 139: 607-616. PMID: 23681403, PMCID: PMC3920483, DOI: 10.1007/s10549-013-2562-6.Peer-Reviewed Original ResearchConceptsSelf-reported cognitive functionCognitive function scoresCognitive functionOlder womenAdjuvant chemotherapyBreast cancerTime pointsStandard adjuvant chemotherapyAverage baseline scoreBaseline cognitive functionCALGB 49907Life substudyCognitive changesPerformance statusStandard chemotherapyMedian agePatient characteristicsTreatment armsTreatment regimenFunction scoresHealthy groupBaseline depressionCognitive screeningChemotherapyKruskal-Wallis testPsychosexual Functioning and Body Image Following a Diagnosis of Ductal Carcinoma In Situ
Bober SL, Giobbie‐Hurder A, Emmons KM, Winer E, Partridge A. Psychosexual Functioning and Body Image Following a Diagnosis of Ductal Carcinoma In Situ. The Journal Of Sexual Medicine 2013, 10: 370-377. PMID: 22812628, DOI: 10.1111/j.1743-6109.2012.02852.x.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic Agents, HormonalArousalBody ImageBreast NeoplasmsCarcinoma, Intraductal, NoninfiltratingCohort StudiesCombined Modality TherapyDepressive DisorderFemaleFollow-Up StudiesHumansMassachusettsMastectomyMiddle AgedPersonal SatisfactionSexual BehaviorSurveys and QuestionnairesConceptsDiagnosis of DCISSexual functionHormonal therapyDuctal carcinomaPsychosexual functioningSexual functioningLarge-scale prospective studiesBody imageInvasive breast cancerProspective studyTreatment modalitiesTreatment optionsProspective surveySitu cancerBreast cancerDCISGeneral populationPsychosexual functionPatientsPsychosocial challengesDiagnosisTime pointsWomenMastectomySexual satisfaction
2012
Evaluation of gene expression by RNA-seq after single dose of trastuzumab (T) reveals predictors of pathologic complete response (pCR) in HER2-positive early breast cancer.
Galanina N, Sprecher E, Bossuyt V, Sarkar S, Krop I, Winer E, Tuck D, Bruce C, Harris L. Evaluation of gene expression by RNA-seq after single dose of trastuzumab (T) reveals predictors of pathologic complete response (pCR) in HER2-positive early breast cancer. Journal Of Clinical Oncology 2012, 30: 10558-10558. DOI: 10.1200/jco.2012.30.15_suppl.10558.Peer-Reviewed Original ResearchPathologic complete responseSingle doseClinical trialsHER2-positive early breast cancerEarly breast cancer patientsEarly breast cancerBreast cancer patientsTumor core biopsiesSubsequent clinical trialsWeek time pointMost gene expression changesComplete responseCancer patientsPredictive markerCore biopsyBreast cancerImmune pathwaysTumorsTime pointsB2MGene expression changesBrief exposureHER2DoseTrials
2009
Assays of circulating tumor cells and outcome in the triple-negative breast cancer trial TBCRC001.
Rugo H, Carey L, Mayer E, Marcom P, Liu M, Ma C, Storniolo A, Forero A, Esteva F, Wolff A, Hobday T, Ferraro M, Davidson N, Winer E, Moore D, Scott J, Park J. Assays of circulating tumor cells and outcome in the triple-negative breast cancer trial TBCRC001. Cancer Research 2009, 69: 6048. DOI: 10.1158/0008-5472.sabcs-6048.Peer-Reviewed Original ResearchBasal-like breast cancerArm 1Study treatmentCTC levelsTumor cellsPhase II studyPhase II trialTime pointsBreast cancer trialsMarkers of activityRank correlation coefficientCc bloodMetastatic BrCaShorter TSTPrimary endpointII studyII trialObjective responseFirst infusionCancer trialsEfficacy dataArm 2Breast cancerCTC measurementCTC enumeration