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 outcomesSeven-Year Follow-Up Analysis of Adjuvant Paclitaxel and Trastuzumab Trial for Node-Negative, Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer
Tolaney SM, Guo H, Pernas S, Barry WT, Dillon DA, Ritterhouse L, Schneider BP, Shen F, Fuhrman K, Baltay M, Dang CT, Yardley DA, Moy B, Marcom PK, Albain KS, Rugo HS, Ellis MJ, Shapira I, Wolff AC, Carey LA, Overmoyer B, Partridge AH, Hudis CA, Krop IE, Burstein HJ, Winer EP. Seven-Year Follow-Up Analysis of Adjuvant Paclitaxel and Trastuzumab Trial for Node-Negative, Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer. Journal Of Clinical Oncology 2019, 37: jco.19.00066. PMID: 30939096, PMCID: PMC7587424, DOI: 10.1200/jco.19.00066.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overBreast NeoplasmsBreast Neoplasms, MaleChemotherapy, AdjuvantDisease-Free SurvivalFemaleFollow-Up StudiesGene Expression Regulation, NeoplasticGenetic Predisposition to DiseaseGenotypeHumansLymph NodesMaleMiddle AgedPaclitaxelPeripheral Nervous System DiseasesPoisson DistributionPolymorphism, Single NucleotideReceptor, ErbB-2RecurrenceRiskTrastuzumabTreatment OutcomeConceptsDisease-free survivalRecurrence-free intervalSmall HER2-positive tumorsAdjuvant paclitaxelHER2-positive tumorsLong-term outcomesTrastuzumab trialsBreast cancerOverall survivalSmall human epidermal growth factor receptor 2Breast cancer-specific survivalPaclitaxel-induced peripheral neuropathyExcellent long-term outcomesHuman epidermal growth factor receptor 2HER2-positive breast cancerEpidermal growth factor receptor 2Human epidermal growth factor receptorPAM50 intrinsic subtypesCancer-specific survivalPhase II studyPrimary end pointGrowth factor receptor 2Positive breast cancerTreatment of patientsSeven-year follow
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 ResearchMeSH KeywordsAlbuminsAntineoplastic AgentsBreast NeoplasmsDose-Response Relationship, DrugEpothilonesFemaleHumansModels, BiologicalNeoplasm MetastasisPaclitaxelPeripheral Nervous System DiseasesConceptsChemotherapy-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
2014
Polygenic inheritance of paclitaxel-induced sensory peripheral neuropathy driven by axon outgrowth gene sets in CALGB 40101 (Alliance)
Chhibber A, Mefford J, Stahl EA, Pendergrass SA, Baldwin RM, Owzar K, Li M, Winer EP, Hudis CA, Zembutsu H, Kubo M, Nakamura Y, McLeod HL, Ratain MJ, Shulman LN, Ritchie MD, Plenge RM, Witte JS, Kroetz DL. Polygenic inheritance of paclitaxel-induced sensory peripheral neuropathy driven by axon outgrowth gene sets in CALGB 40101 (Alliance). The Pharmacogenomics Journal 2014, 14: 336-342. PMID: 24513692, PMCID: PMC4111770, DOI: 10.1038/tpj.2014.2.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic Agents, PhytogenicAxonsBreast NeoplasmsFemaleHumansMultifactorial InheritancePaclitaxelPeripheral Nervous System DiseasesPolymorphism, Single NucleotideSensory Receptor CellsConceptsSensory peripheral neuropathyPaclitaxel-induced peripheral neuropathyPeripheral neuropathyCALGB 40101Common dose-limiting toxicityPhase III clinical trialsPaclitaxel-induced neuropathyDose-limiting toxicityAxon outgrowthPaclitaxel armAdjuvant therapyAdverse eventsSusceptible patientsRisk factorsClinical trialsBreast cancerNeuropathyPaclitaxel treatmentClinical decisionPatientsPatient informationMaximum gradeHeritable componentMost individualsTreatment
2013
Integration of Cell Line and Clinical Trial Genome-Wide Analyses Supports a Polygenic Architecture of Paclitaxel-Induced Sensory Peripheral Neuropathy
Wheeler HE, Gamazon ER, Wing C, Njiaju UO, Njoku C, Baldwin RM, Owzar K, Jiang C, Watson D, Shterev I, Kubo M, Zembutsu H, Winer EP, Hudis CA, Shulman LN, Nakamura Y, Ratain MJ, Kroetz DL, B F, Cox NJ, Dolan ME. Integration of Cell Line and Clinical Trial Genome-Wide Analyses Supports a Polygenic Architecture of Paclitaxel-Induced Sensory Peripheral Neuropathy. Clinical Cancer Research 2013, 19: 491-499. PMID: 23204130, PMCID: PMC3549006, DOI: 10.1158/1078-0432.ccr-12-2618.Peer-Reviewed Original ResearchConceptsExpression quantitative trait lociSingle nucleotide polymorphismsPolygenic architectureGenome-wide association study resultsLymphoblastoid cell line (LCL) modelGenome-wide analysisSignificant enrichmentQuantitative trait lociRegulatory factor X (RFX) familyAssociation study resultsRelevant genetic variantsGWAS resultsTrait lociAllelic directionCell line modelsRelated traitsHapMap projectEnrichment resultsPaclitaxel-induced cytotoxicityCellular modelReduced neurite outgrowthGenetic variantsRFX2Neurite outgrowthCell lines
2012
A Genome-Wide Association Study Identifies Novel Loci for Paclitaxel-Induced Sensory Peripheral Neuropathy in CALGB 40101
Baldwin RM, Owzar K, Zembutsu H, Chhibber A, Kubo M, Jiang C, Watson D, Eclov RJ, Mefford J, McLeod HL, Friedman PN, Hudis CA, Winer EP, Jorgenson EM, Witte JS, Shulman LN, Nakamura Y, Ratain MJ, Kroetz DL. A Genome-Wide Association Study Identifies Novel Loci for Paclitaxel-Induced Sensory Peripheral Neuropathy in CALGB 40101. Clinical Cancer Research 2012, 18: 5099-5109. PMID: 22843789, PMCID: PMC3445665, DOI: 10.1158/1078-0432.ccr-12-1590.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Agents, PhytogenicBreast NeoplasmsFemaleGenetic LociGenetic Predisposition to DiseaseGenome-Wide Association StudyGenotypeHumansIncidenceMicrofilament ProteinsMiddle AgedPaclitaxelPeripheral Nervous System DiseasesPolymorphism, Single NucleotideReceptor, EphA5Sensory Receptor CellsConceptsSensory peripheral neuropathyWide association studyPeripheral neuropathyCALGB 40101Genome-wide association study identifies novel lociAssociation studiesPrimary breast cancerIdentification of patientsNovel genetic markersGenetic risk factorsAfrican American subjectsSingle nucleotide polymorphismsAdditional EuropeanNovel lociPaclitaxel armAdditional genesGenetic variationPaclitaxel therapyClinical managementRisk factorsBreast cancerDiscovery cohortPharmacogenetic analysisNeuropathyGenetic markers
2004
Long-Term Complications of Adjuvant Chemotherapy for Early Stage Breast Cancer
Partridge AH, Winer EP. Long-Term Complications of Adjuvant Chemotherapy for Early Stage Breast Cancer. Breast Disease 2004, 21: 55-64. PMID: 15687723, DOI: 10.3233/bd-2004-21108.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Agents, HormonalAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCardiovascular DiseasesChemotherapy, AdjuvantCognition DisordersDose-Response Relationship, DrugDrug Administration ScheduleFemaleHumansMastectomy, SegmentalMiddle AgedNeoplasm StagingPeripheral Nervous System DiseasesPrognosisRandomized Controlled Trials as TopicRisk AssessmentSurvival AnalysisTime FactorsTreatment OutcomeConceptsLong-term complicationsEarly-stage breast cancerAdjuvant chemotherapyStage breast cancerBreast cancerSide effectsRare long-term complicationAcute side effectsLong-term riskTerm complicationsSpecific complicationsRisk factorsIncidence rateLong-term effectsChemotherapyComplicationsLate onsetSustained impactCancerReview detailsPotential riskRiskPatientsEtiologyTherapy