2021
Factors associated with late risks of breast cancer-specific mortality in the SEER registry
Leone JP, Vallejo CT, Hassett MJ, Leone J, Graham N, Tayob N, Freedman RA, Tolaney SM, Leone BA, Winer EP, Lin NU. Factors associated with late risks of breast cancer-specific mortality in the SEER registry. Breast Cancer Research And Treatment 2021, 189: 203-212. PMID: 33893907, PMCID: PMC8302525, DOI: 10.1007/s10549-021-06233-4.Peer-Reviewed Original ResearchMeSH KeywordsBreast NeoplasmsFemaleHumansKaplan-Meier EstimateNeoplasm StagingPrognosisRegistriesSEER ProgramConceptsBC-specific mortalityHR-positive breast cancerHR-negative breast cancerBreast cancerHR statusCumulative riskBreast cancer-specific mortalityCancer-specific mortalityT1a/bHormone receptor statusYear of diagnosisKaplan-Meier analysisLong-term riskBC deathConclusionThe risksGray regressionN2 diseaseLate relapseReceptor statusLate recurrenceSEER registryLater riskClinical trialsYear 5PatientsTumor subtypes and survival in male breast cancer
Leone J, Freedman RA, Lin NU, Tolaney SM, Vallejo CT, Leone BA, Winer EP, Leone JP. Tumor subtypes and survival in male breast cancer. Breast Cancer Research And Treatment 2021, 188: 695-702. PMID: 33770314, DOI: 10.1007/s10549-021-06182-y.Peer-Reviewed Original ResearchMeSH KeywordsAgedBiomarkers, TumorBreast NeoplasmsBreast Neoplasms, MaleHumansKaplan-Meier EstimateMalePrognosisReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneConceptsBreast cancer-specific survivalOverall survivalTumor subtypesBreast cancerHormone receptorsWorse breast cancer-specific survivalMultivariate Cox proportional hazards analysisCox proportional hazards analysisPurposeMale breast cancerTumor subtype distributionCancer-specific survivalProportional hazards analysisInvasive breast cancerMale breast cancerAggressive tumor biologyCox hazard ratiosPopulation-based informationTN diseaseAdvanced diseaseHazard ratioHR-/HER2Inferior survivalMedian agePatient characteristicsPrognostic factorsGenomic Characterization of de novo Metastatic Breast Cancer
Garrido-Castro AC, Spurr LF, Hughes ME, Li YY, Cherniack AD, Kumari P, Lloyd MR, Bychkovsky B, Barroso-Sousa R, Di Lascio S, Jain E, Files J, Mohammed-Abreu A, Krevalin M, MacKichan C, Barry WT, Guo H, Xia D, Cerami E, Rollins BJ, MacConaill LE, Lindeman NI, Krop IE, Johnson BE, Wagle N, Winer EP, Dillon DA, Lin NU. Genomic Characterization of de novo Metastatic Breast Cancer. Clinical Cancer Research 2021, 27: 1105-1118. PMID: 33293374, PMCID: PMC7887078, DOI: 10.1158/1078-0432.ccr-20-1720.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerPrimary tumorOverall survivalBreast cancerDe novo metastatic breast cancerNovo metastatic breast cancerDifferential therapeutic sensitivityBetter OSPoor OSShorter OSInitial diagnosisHigh TMBMetastatic tumorsDnMBCCurrent treatmentMutational burdenTreatment selectionMetastatic driversStage IMultiple comparison adjustmentTherapeutic sensitivityTumorsPatientsCancerIntrinsic resistance
2020
Phase II trial of carboplatin and bevacizumab in patients with breast cancer brain metastases
Leone JP, Emblem KE, Weitz M, Gelman RS, Schneider BP, Freedman RA, Younger J, Pinho MC, Sorensen AG, Gerstner ER, Harris G, Krop IE, Morganstern D, Sohl J, Hu J, Kasparian E, Winer EP, Lin NU. Phase II trial of carboplatin and bevacizumab in patients with breast cancer brain metastases. Breast Cancer Research 2020, 22: 131. PMID: 33256829, PMCID: PMC7706261, DOI: 10.1186/s13058-020-01372-w.Peer-Reviewed Original ResearchMeSH KeywordsAdultAntineoplastic Combined Chemotherapy ProtocolsBevacizumabBrainBrain NeoplasmsBreastBreast NeoplasmsCarboplatinFemaleGenotyping TechniquesHumansKaplan-Meier EstimateMagnetic Resonance ImagingMiddle AgedPolymorphism, Single NucleotideProgression-Free SurvivalTrastuzumabVascular Endothelial Growth Factor AConceptsProgression-free survivalBreast cancer brain metastasesEarly MRI changesCancer brain metastasesBrain metastasesOverall survivalMRI changesBreast cancerEastern Cooperative Oncology Group performance statusDay 1Cycle 1 day 1Cycle 1 day 8Median progression-free survivalWorse progression-free survivalRegimen warrants further investigationDurable objective responsesECOG PS 1Efficacy of bevacizumabHER2-positive diseaseProgressive brain metastasesResultsThirty-eight patientsMedian overall survivalObjective response ratePhase II trialContrast-enhanced brain MRI
2019
Tucatinib, Trastuzumab, and Capecitabine for HER2-Positive Metastatic Breast Cancer
Murthy RK, Loi S, Okines A, Paplomata E, Hamilton E, Hurvitz SA, Lin NU, Borges V, Abramson V, Anders C, Bedard PL, Oliveira M, Jakobsen E, Bachelot T, Shachar SS, Müller V, Braga S, Duhoux FP, Greil R, Cameron D, Carey LA, Curigliano G, Gelmon K, Hortobagyi G, Krop I, Loibl S, Pegram M, Slamon D, Palanca-Wessels MC, Walker L, Feng W, Winer EP. Tucatinib, Trastuzumab, and Capecitabine for HER2-Positive Metastatic Breast Cancer. New England Journal Of Medicine 2019, 382: 597-609. PMID: 31825569, DOI: 10.1056/nejmoa1914609.Peer-Reviewed Original ResearchMeSH KeywordsAgedAntineoplastic Combined Chemotherapy ProtocolsBrain NeoplasmsBreast NeoplasmsCapecitabineConsolidation ChemotherapyDiarrheaDouble-Blind MethodFemaleHumansKaplan-Meier EstimateMiddle AgedOxazolesProgression-Free SurvivalProtein-Tyrosine KinasesPyridinesQuinazolinesReceptor, ErbB-2TrastuzumabConceptsHER2-positive metastatic breast cancerProgression-free survivalPlacebo-combination groupMetastatic breast cancerElevated aminotransferase levelsBrain metastasesBreast cancerOverall survivalAminotransferase levelsMedian progression-free survivalPalmar-plantar erythrodysesthesia syndromeBetter progression-free survivalPositive metastatic breast cancerHuman epidermal growth factor receptor 2End pointEpidermal growth factor receptor 2Common adverse eventsMedian overall survivalObjective response ratePrimary end pointSecondary end pointsGrowth factor receptor 2Overall survival outcomesRisk of diarrheaFactor receptor 2The immune profile of small HER2-positive breast cancers: a secondary analysis from the APT trial
Barroso-Sousa R, Barry WT, Guo H, Dillon D, Tan YB, Fuhrman K, Osmani W, Getz A, Baltay M, Dang C, Yardley D, Moy B, Marcom PK, Mittendorf EA, Krop IE, Winer EP, Tolaney SM. The immune profile of small HER2-positive breast cancers: a secondary analysis from the APT trial. Annals Of Oncology 2019, 30: 575-581. PMID: 30753274, PMCID: PMC8033534, DOI: 10.1093/annonc/mdz047.Peer-Reviewed Original ResearchMeSH KeywordsAgedAntineoplastic Combined Chemotherapy ProtocolsB7-H1 AntigenBiomarkers, TumorBreastBreast NeoplasmsChemotherapy, AdjuvantDisease-Free SurvivalFemaleFollow-Up StudiesHumansKaplan-Meier EstimateMastectomyMiddle AgedPaclitaxelReceptor, ErbB-2TrastuzumabTumor BurdenTumor MicroenvironmentConceptsHER2-positive breast cancerSmall HER2-positive breast cancersImmune gene signaturesBreast cancerImmune profileAPT trialPD-L1Immune markersImmune microenvironmentSmall HER2-positive tumorsStromal PD-L1 expressionNode-negative breast cancerCell signatureGene signatureHuman epidermal growth factor receptorStromal PD-L1PD-L1 expressionHistological grade 2Luminal B tumorsB cell signaturesBreast cancer trialsHER2-positive tumorsImmune cell signaturesBasal-like tumorsHistological grade 1
2018
Androgen Receptor Expression and Breast Cancer Survival: Results From the Nurses’ Health Studies
Kensler KH, Poole EM, Heng YJ, Collins LC, Glass B, Beck AH, Hazra A, Rosner BA, Eliassen AH, Hankinson SE, Winer EP, Brown M, Tamimi RM. Androgen Receptor Expression and Breast Cancer Survival: Results From the Nurses’ Health Studies. Journal Of The National Cancer Institute 2018, 111: 700-708. PMID: 30445651, PMCID: PMC6624168, DOI: 10.1093/jnci/djy173.Peer-Reviewed Original ResearchConceptsBreast cancer mortalityHealth Study II cohortNurses' Health StudyAR protein expressionCancer mortalityBreast cancerLog-linear associationAR expressionHealth StudyAndrogen receptorER- cancersHazard ratioNurses' Health Study II cohortCox proportional hazards modelProtein expressionInvasive breast cancerAndrogen receptor expressionBreast cancer survivalConfidence intervalsProportional hazards modelHormone receptor signalingPostmenopausal womenNegative tumorsWorse prognosisYears postdiagnosisTailoring 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 3ExemestaneTamoxifenBreast cancer‐specific survival by age: Worse outcomes for the oldest patients
Freedman RA, Keating NL, Lin NU, Winer EP, Vaz‐Luis I, Lii J, Exman P, Barry WT. Breast cancer‐specific survival by age: Worse outcomes for the oldest patients. Cancer 2018, 124: 2184-2191. PMID: 29499074, PMCID: PMC5935594, DOI: 10.1002/cncr.31308.Peer-Reviewed Original ResearchConceptsBreast cancer-specific deathCancer-specific deathTriple-negative diseaseHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Growth factor receptor 2Breast cancer outcomesOlder patientsFactor receptor 2Breast cancerCancer outcomesReceptor 2Disease subtypesWorse breast cancer outcomesHR-positive diseaseCancer stage IEnd Results (SEER) dataAmerican Joint CommitteePopulation-based cohortStage of diseaseGray regression modelsAdjusted hazardClinical variablesDisease stageHigh riskCharacterization of male breast cancer: results of the EORTC 10085/TBCRC/BIG/NABCG International Male Breast Cancer Program
Cardoso F, Bartlett J, Slaets L, van Deurzen C, van Leeuwen-Stok E, Porter P, Linderholm B, Hedenfalk I, Schröder C, Martens J, Bayani J, van Asperen C, Murray M, Hudis C, Middleton L, Vermeij J, Punie K, Fraser J, Nowaczyk M, Rubio I, Aebi S, Kelly C, Ruddy K, Winer E, Nilsson C, Dal Lago L, Korde L, Benstead K, Bogler O, Goulioti T, Peric A, Litière S, Aalders K, Poncet C, Tryfonidis K, Giordano S. Characterization of male breast cancer: results of the EORTC 10085/TBCRC/BIG/NABCG International Male Breast Cancer Program. Annals Of Oncology 2018, 29: 405-417. PMID: 29092024, PMCID: PMC5834077, DOI: 10.1093/annonc/mdx651.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedBiomarkers, TumorBreast Neoplasms, MaleHumansKaplan-Meier EstimateMaleMiddle AgedProportional Hazards ModelsRetrospective StudiesConceptsRecurrence-free survivalMale breast cancerAdjuvant endocrine therapyBreast cancerEndocrine therapySentinel lymph node biopsyLymph node biopsyBreast cancer programFemale breast cancerDuctal invasive carcinomaBC mortalityIHC subtypesIHC surrogatesAdjuvant radiotherapyM1 patientsMetastatic diseaseMedian ageCentral pathologyM0 tumorsM0 casesProgesterone receptorCancer programsInvasive carcinomaKi67 expressionAndrogen receptorEnzalutamide for the Treatment of Androgen Receptor–Expressing Triple-Negative Breast Cancer
Traina TA, Miller K, Yardley DA, Eakle J, Schwartzberg LS, O'Shaughnessy J, Gradishar W, Schmid P, Winer E, Kelly C, Nanda R, Gucalp A, Awada A, Garcia-Estevez L, Trudeau ME, Steinberg J, Uppal H, Tudor IC, Peterson A, Cortes J. Enzalutamide for the Treatment of Androgen Receptor–Expressing Triple-Negative Breast Cancer. Journal Of Clinical Oncology 2018, 36: jco.2016.71.349. PMID: 29373071, PMCID: PMC5858523, DOI: 10.1200/jco.2016.71.3495.Peer-Reviewed Original ResearchConceptsTriple-negative breast cancerClinical benefit rateAR-positive triple-negative breast cancerProgression-free survivalAndrogen receptorNuclear androgen receptorEvaluable subgroupITT populationBreast cancerEnd pointAdverse eventsAdvanced triple-negative breast cancerMedian progression-free survivalTreatment-related grade 3Safety of enzalutamideHigher adverse eventsMedian overall survivalPhase II studyPrimary end pointSecondary end pointsSubset of patientsII studyOverall survivalPostbaseline assessmentSafety profile
2017
Using ePrognosis to estimate 2-year all-cause mortality in older women with breast cancer: Cancer and Leukemia Group B (CALGB) 49907 and 369901 (Alliance A151503)
Kimmick GG, Major B, Clapp J, Sloan J, Pitcher B, Ballman K, Barginear M, Freedman RA, Artz A, Klepin HD, Lafky JM, Hopkins J, Winer E, Hudis C, Muss H, Cohen H, Jatoi A, Hurria A, Mandelblatt J. Using ePrognosis to estimate 2-year all-cause mortality in older women with breast cancer: Cancer and Leukemia Group B (CALGB) 49907 and 369901 (Alliance A151503). Breast Cancer Research And Treatment 2017, 163: 391-398. PMID: 28283904, PMCID: PMC5508575, DOI: 10.1007/s10549-017-4188-6.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overBreast NeoplasmsClinical Trials as TopicFemaleHumansKaplan-Meier EstimateLeukemiaPrognosisQuality of LifeConceptsMortality rateBreast cancerNon-cancer mortality risksOlder breast cancer patientsStage I-IIA diseaseTwo-year mortality rateAdjuvant therapy decisionsResultsPatients' mean ageCooperative group studiesKaplan-Meier methodOverall survival estimatesBreast cancer patientsAvailable clinical informationCommunity-dwelling eldersObserved mortality rateBreast Cancer StudyAdjuvant therapyCause mortalityMost patientsOlder patientsBetter prognosisWorse prognosisPoor prognosisTrial populationMean agePhase II and Biomarker Study of Cabozantinib in Metastatic Triple‐Negative Breast Cancer Patients
Tolaney SM, Ziehr DR, Guo H, Ng MR, Barry WT, Higgins MJ, Isakoff SJ, Brock JE, Ivanova EV, Paweletz CP, Demeo MK, Ramaiya NH, Overmoyer BA, Jain RK, Winer EP, Duda DG. Phase II and Biomarker Study of Cabozantinib in Metastatic Triple‐Negative Breast Cancer Patients. The Oncologist 2017, 22: 25-32. PMID: 27789775, PMCID: PMC5313267, DOI: 10.1634/theoncologist.2016-0229.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAnilidesBiomarkers, TumorDisease-Free SurvivalFemaleHumansKaplan-Meier EstimateMiddle AgedMolecular Targeted TherapyNeoplasm MetastasisPlacenta Growth FactorProtein Kinase InhibitorsProto-Oncogene Proteins c-metPyridinesTriple Negative Breast NeoplasmsVascular Endothelial Growth Factor DVascular Endothelial Growth Factor Receptor-2ConceptsProgression-free survivalVascular endothelial growth factorBreast cancer patientsStable diseasePrimary endpointPartial responseCancer patientsBreast cancerMetastatic triple-negative breast cancer patientsMedian progression-free survivalSingle-arm phase IILonger progression-free survivalTriple-negative breast cancer patientsSoluble VEGF receptor 2Plasma placental growth factorTriple-negative breast cancerBiomarker studiesGrowth factorClinical benefit rateCytotoxic lymphocyte populationsGrade 4 toxicityObjective response ratePalmar-plantar erythrodysesthesiaSubset of patientsStromal cell-derived factor 1a
2016
Ribociclib as First-Line Therapy for HR-Positive, Advanced Breast Cancer
Hortobagyi GN, Stemmer SM, Burris HA, Yap YS, Sonke GS, Paluch-Shimon S, Campone M, Blackwell KL, André F, Winer EP, Janni W, Verma S, Conte P, Arteaga CL, Cameron DA, Petrakova K, Hart LL, Villanueva C, Chan A, Jakobsen E, Nusch A, Burdaeva O, Grischke EM, Alba E, Wist E, Marschner N, Favret AM, Yardley D, Bachelot T, Tseng LM, Blau S, Xuan F, Souami F, Miller M, Germa C, Hirawat S, O'Shaughnessy J. Ribociclib as First-Line Therapy for HR-Positive, Advanced Breast Cancer. New England Journal Of Medicine 2016, 375: 1738-1748. PMID: 27717303, DOI: 10.1056/nejmoa1609709.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAminopyridinesAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsDisease-Free SurvivalDouble-Blind MethodDrug Administration ScheduleFemaleHumansKaplan-Meier EstimateLetrozoleMiddle AgedNeoplasm StagingNitrilesPurinesReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneTriazolesConceptsAdvanced breast cancerProgression-free survivalHuman epidermal growth factor receptor 2Overall response rateRibociclib groupBreast cancerPlacebo groupAdverse eventsInvestigator-assessed progression-free survivalHER2-negative advanced breast cancerResponse rateProgression-free survival ratesEnd pointEpidermal growth factor receptor 2Hormone receptorsCDK4/6 inhibitor ribociclibCommon grade 3Initial systemic treatmentPrevious systemic therapyPrimary end pointSecondary end pointsFirst-line treatmentPhase 3 trialRate of discontinuationGrowth factor receptor 2Extending Aromatase-Inhibitor Adjuvant Therapy to 10 Years
Goss PE, Ingle JN, Pritchard KI, Robert NJ, Muss H, Gralow J, Gelmon K, Whelan T, Strasser-Weippl K, Rubin S, Sturtz K, Wolff AC, Winer E, Hudis C, Stopeck A, Beck JT, Kaur JS, Whelan K, Tu D, Parulekar WR. Extending Aromatase-Inhibitor Adjuvant Therapy to 10 Years. New England Journal Of Medicine 2016, 375: 209-219. PMID: 27264120, PMCID: PMC5024713, DOI: 10.1056/nejmoa1604700.Peer-Reviewed Original ResearchConceptsContralateral breast cancerDisease-free survivalAromatase inhibitorsBreast cancerOverall survivalDisease-free survival ratesPositive early breast cancerAdjuvant aromatase inhibitorsNew-onset osteoporosisPlacebo-controlled trialPrimary end pointEarly breast cancerAnnual incidence rateTreatment of choiceBreast cancer recurrenceExtension of treatmentQuality of lifeBone painLetrozole groupAdjuvant therapyPlacebo groupPostmenopausal womenDisease recurrenceIncidence rateLower incidence
2015
Body Mass Index, PAM50 Subtype, and Outcomes in Node-Positive Breast Cancer: CALGB 9741 (Alliance)
Ligibel JA, Cirrincione CT, Liu M, Citron M, Ingle JN, Gradishar W, Martino S, Sikov W, Michaelson R, Mardis E, Perou CM, Ellis M, Winer E, Hudis CA, Berry D, Barry WT. Body Mass Index, PAM50 Subtype, and Outcomes in Node-Positive Breast Cancer: CALGB 9741 (Alliance). Journal Of The National Cancer Institute 2015, 107: djv179. PMID: 26113580, PMCID: PMC4651106, DOI: 10.1093/jnci/djv179.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Combined Chemotherapy ProtocolsBody Mass IndexBreast NeoplasmsCyclophosphamideDisease-Free SurvivalDoxorubicinDrug Administration ScheduleFemaleFollow-Up StudiesHumansKaplan-Meier EstimateLymph NodesLymphatic MetastasisMiddle AgedNeoplasm Recurrence, LocalPaclitaxelReceptors, EstrogenTreatment OutcomeConceptsBody mass indexBaseline body mass indexNode-positive breast cancerBreast cancerCALGB 9741Prognostic factorsMass indexMedian baseline body mass indexSignificant prognostic factorsIndependent prognostic factorBreast cancer outcomesGroup of patientsSequence of chemotherapyEstrogen receptor statusProportional hazards regressionActual body weightDose densityDosed chemotherapyMenopausal statusOverall survivalReceptor statusRandomized trialsHazards regressionPoor prognosisTumor sizeGenomic Analysis Reveals That Immune Function Genes Are Strongly Linked to Clinical Outcome in the North Central Cancer Treatment Group N9831 Adjuvant Trastuzumab Trial
Perez EA, Thompson EA, Ballman KV, Anderson SK, Asmann YW, Kalari KR, Eckel-Passow JE, Dueck AC, Tenner KS, Jen J, Fan JB, Geiger XJ, McCullough AE, Chen B, Jenkins RB, Sledge GW, Winer EP, Gralow JR, Reinholz MM. Genomic Analysis Reveals That Immune Function Genes Are Strongly Linked to Clinical Outcome in the North Central Cancer Treatment Group N9831 Adjuvant Trastuzumab Trial. Journal Of Clinical Oncology 2015, 33: 701-708. PMID: 25605861, PMCID: PMC4334774, DOI: 10.1200/jco.2014.57.6298.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsChemotherapy, AdjuvantDisease-Free SurvivalDNA, NeoplasmFemaleGene Expression Regulation, NeoplasticGenomicsHumansKaplan-Meier EstimateMiddle AgedMolecular Targeted TherapyProportional Hazards ModelsReceptor, ErbB-2TranscriptomeTrastuzumabConceptsRelapse-free survivalImmune function genesAdjuvant trastuzumab trialsArm BTrastuzumab trialsHazard ratioArm AHuman epidermal growth factor receptorClinicopathologic risk factorsProportional hazard ratiosEpidermal growth factor receptorGrowth factor receptorAdjuvant trastuzumabC patientsCombination chemotherapyClinical outcomesRisk factorsBreast cancerPatientsTrastuzumabPredictive signatureFunction genesChemotherapyGene enrichmentFactor receptor
2014
Phase III Study of Iniparib Plus Gemcitabine and Carboplatin Versus Gemcitabine and Carboplatin in Patients With Metastatic Triple-Negative Breast Cancer
O'Shaughnessy J, Schwartzberg L, Danso MA, Miller KD, Rugo HS, Neubauer M, Robert N, Hellerstedt B, Saleh M, Richards P, Specht JM, Yardley DA, Carlson RW, Finn RS, Charpentier E, Garcia-Ribas I, Winer EP. Phase III Study of Iniparib Plus Gemcitabine and Carboplatin Versus Gemcitabine and Carboplatin in Patients With Metastatic Triple-Negative Breast Cancer. Journal Of Clinical Oncology 2014, 32: 3840-3847. PMID: 25349301, DOI: 10.1200/jco.2014.55.2984.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic Combined Chemotherapy ProtocolsBenzamidesCarboplatinDeoxycytidineDisease ProgressionDisease-Free SurvivalFemaleGemcitabineHumansKaplan-Meier EstimateMiddle AgedNeoplasm Recurrence, LocalNeoplasm StagingProportional Hazards ModelsRisk FactorsTime FactorsTreatment OutcomeTriple Negative Breast NeoplasmsUnited StatesConceptsMetastatic triple-negative breast cancerProgression-free survivalTriple-negative breast cancerCoprimary end pointsOverall survivalBreast cancerRandomized phase II trialEnd pointStage IV/Clinical benefit ratePhase II trialPhase III studyPhase III trialsStandard of careWarrants further evaluationLack of treatmentCarboplatin areaITT populationPrevious chemotherapyPrior chemotherapyII trialIII studyIII trialsSurvival benefitSafety profileCombination 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 1Comorbidity, Chemotherapy Toxicity, and Outcomes Among Older Women Receiving Adjuvant Chemotherapy for Breast Cancer on a Clinical Trial: CALGB 49907 and CALGB 361004 (Alliance)
Klepin HD, Pitcher BN, Ballman KV, Kornblith AB, Hurria A, Winer EP, Hudis C, Cohen HJ, Muss HB, Kimmick GG. Comorbidity, Chemotherapy Toxicity, and Outcomes Among Older Women Receiving Adjuvant Chemotherapy for Breast Cancer on a Clinical Trial: CALGB 49907 and CALGB 361004 (Alliance). JCO Oncology Practice 2014, 10: e285-e292. PMID: 25074878, PMCID: PMC4161730, DOI: 10.1200/jop.2014.001388.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overAntineoplastic AgentsBreast NeoplasmsCapecitabineChemotherapy, AdjuvantComorbidityDeoxycytidineDisease-Free SurvivalFemaleFluorouracilHumansKaplan-Meier EstimateMultivariate AnalysisProportional Hazards ModelsQuality of LifeRegression AnalysisSurveys and QuestionnairesTreatment OutcomeConceptsOverall survivalAdjuvant chemotherapyBurden scoreBreast cancerOlder womenShorter OSClinical trialsEarly-stage breast cancerCox proportional hazards modelStandard adjuvant chemotherapyNumber of comorbiditiesHazard of deathPhysical health subscaleOlder Americans ResourcesProportional hazards modelCALGB 49907Chemotherapy toxicityReceptor statusComorbid conditionsTumor sizeHealth subscaleGrade 3ComorbiditiesCommon conditionHazards model