2023
Tucatinib vs Placebo, Both in Combination With Trastuzumab and Capecitabine, for Previously Treated ERBB2 (HER2)-Positive Metastatic Breast Cancer in Patients With Brain Metastases
Lin N, Murthy R, Abramson V, Anders C, Bachelot T, Bedard P, Borges V, Cameron D, Carey L, Chien A, Curigliano G, DiGiovanna M, Gelmon K, Hortobagyi G, Hurvitz S, Krop I, Loi S, Loibl S, Mueller V, Oliveira M, Paplomata E, Pegram M, Slamon D, Zelnak A, Ramos J, Feng W, Winer E. Tucatinib vs Placebo, Both in Combination With Trastuzumab and Capecitabine, for Previously Treated ERBB2 (HER2)-Positive Metastatic Breast Cancer in Patients With Brain Metastases. JAMA Oncology 2023, 9: 197-205. PMID: 36454580, PMCID: PMC9716438, DOI: 10.1001/jamaoncol.2022.5610.Peer-Reviewed Original ResearchConceptsErbB2-positive metastatic breast cancerMetastatic breast cancerPlacebo-combination groupPositive metastatic breast cancerNew brain lesionsBrain metastasesOverall survivalSubgroup analysisBrain lesionsBreast cancerIntracranial progression-free survivalPlacebo-controlled clinical trialIntracranial objective response rateStable brain metastasesMedian overall survivalObjective response rateProgression-free survivalExploratory subgroup analysisGreater clinical benefitCNS-PFSHER2CLIMB trialIntracranial outcomesFirst progressionMedian ageClinical benefit
2021
Tucatinib versus placebo added to trastuzumab and capecitabine for patients with pretreated HER2+ metastatic breast cancer with and without brain metastases (HER2CLIMB): final overall survival analysis
Curigliano G, Mueller V, Borges V, Hamilton E, Hurvitz S, Loi S, Murthy R, Okines A, Paplomata E, Cameron D, Carey L, Gelmon K, Hortobagyi G, Krop I, Loibl S, Pegram M, Slamon D, Ramos J, Feng W, Winer E. Tucatinib versus placebo added to trastuzumab and capecitabine for patients with pretreated HER2+ metastatic breast cancer with and without brain metastases (HER2CLIMB): final overall survival analysis. Annals Of Oncology 2021, 33: 321-329. PMID: 34954044, DOI: 10.1016/j.annonc.2021.12.005.Peer-Reviewed Original ResearchConceptsProgression-free survivalMetastatic breast cancerPlacebo-combination groupOverall survivalCombination groupBreast cancerHER2CLIMB trialBrain metastasesMedian durationSafety outcomesPrimary analysisFinal overall survival analysisHuman epidermal growth factor receptor 2 positive metastatic breast cancerPositive metastatic breast cancerMeaningful survival benefitMedian overall survivalPlacebo-controlled trialOverall study populationOverall survival analysisFinal OSMetastatic HER2Placebo combinationAdverse eventsLast patientPrespecified subgroupsAssociation of 17q22 Amplicon Via Cell-Free DNA With Platinum Chemotherapy Response in Metastatic Triple-Negative Breast Cancer
Collier KA, Asad S, Tallman D, Jenison J, Rajkovic A, Mardis ER, Parsons HA, Tolaney SM, Winer EP, Lin NU, Ha G, Adalsteinsson VA, Stover DG. Association of 17q22 Amplicon Via Cell-Free DNA With Platinum Chemotherapy Response in Metastatic Triple-Negative Breast Cancer. JCO Precision Oncology 2021, 5: po.21.00104. PMID: 34849445, PMCID: PMC8624042, DOI: 10.1200/po.21.00104.Peer-Reviewed Original ResearchConceptsMetastatic triple-negative breast cancerProgression-free survivalTriple-negative breast cancerPlatinum chemotherapyCancer Genome AtlasBreast cancerBreast Cancer International Consortium data setLonger median progression-free survivalMedian progression-free survivalPlatinum-based chemotherapy regimenSomatic copy number alterationsCopy number alterationsCox proportional hazards modelPlatinum chemotherapy responseTriple negative breast cancer tumorsSpecific somatic copy number alterationsGenome AtlasBreast Cancer International ConsortiumProportional hazards modelBreast cancer tumorsWarrants further investigationCell-free DNAEvaluable patientsChemotherapy regimenMetastatic setting
2020
Intracranial Efficacy and Survival With Tucatinib Plus Trastuzumab and Capecitabine for Previously Treated HER2-Positive Breast Cancer With Brain Metastases in the HER2CLIMB Trial
Lin NU, Borges V, Anders C, Murthy RK, Paplomata E, Hamilton E, Hurvitz S, Loi S, Okines A, Abramson V, Bedard PL, Oliveira M, Mueller V, Zelnak A, DiGiovanna MP, Bachelot T, Chien AJ, O’Regan R, Wardley A, Conlin A, Cameron D, Carey L, Curigliano G, Gelmon K, Loibl S, Mayor J, McGoldrick S, An X, Winer EP. Intracranial Efficacy and Survival With Tucatinib Plus Trastuzumab and Capecitabine for Previously Treated HER2-Positive Breast Cancer With Brain Metastases in the HER2CLIMB Trial. Journal Of Clinical Oncology 2020, 38: 2610-2619. PMID: 32468955, PMCID: PMC7403000, DOI: 10.1200/jco.20.00775.Peer-Reviewed Original ResearchConceptsHER2-positive breast cancerBrain metastasesProgression-free survivalRisk of deathBreast cancerOverall survivalControl armCNS-PFSIntracranial efficacyIntracranial progressionBaseline brain magnetic resonance imagingHuman epidermal growth factor receptor 2Intracranial objective response rateEpidermal growth factor receptor 2Brain magnetic resonance imagingMedian CNS-PFSRECIST 1.1 criteriaMedian overall survivalObjective response rateGrowth factor receptor 2Positive breast cancerFactor receptor 2Magnetic resonance imagingHER2CLIMB trialImproved antitumor activity
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 2Randomized Trial of Standard Adjuvant Chemotherapy Regimens Versus Capecitabine in Older Women With Early Breast Cancer: 10-Year Update of the CALGB 49907 Trial.
Muss HB, Polley MC, Berry DA, Liu H, Cirrincione CT, Theodoulou M, Mauer AM, Kornblith AB, Partridge AH, Dressler LG, Cohen HJ, Kartcheske PA, Perez EA, Wolff AC, Gralow JR, Burstein HJ, Mahmood AA, Sutton LM, Magrinat G, Parker BA, Hart RD, Grenier D, Hurria A, Jatoi A, Norton L, Hudis CA, Winer EP, Carey L. Randomized Trial of Standard Adjuvant Chemotherapy Regimens Versus Capecitabine in Older Women With Early Breast Cancer: 10-Year Update of the CALGB 49907 Trial. Journal Of Clinical Oncology 2019, 37: 2338-2348. PMID: 31339827, PMCID: PMC6900836, DOI: 10.1200/jco.19.00647.Peer-Reviewed Original ResearchConceptsRecurrence-free survivalStandard adjuvant chemotherapyEarly breast cancerAdjuvant chemotherapyAge 65 yearsStandard chemotherapyBreast cancerOlder womenBreast cancer-specific survival ratesSurvival rateHormone receptor-negative diseaseHormone receptor-negative patientsHormone receptor-positive patientsCancer-specific survival ratesPatients age 65 yearsWomen age 65 yearsReceptor-negative patientsReceptor-positive patientsOverall survival benefitPrimary end pointReceptor-negative diseaseOverall survival rateAdaptive Bayesian designNonbreast cancersRFS ratesTBCRC 022: A Phase II Trial of Neratinib and Capecitabine for Patients With Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer and Brain Metastases
Freedman RA, Gelman RS, Anders CK, Melisko ME, Parsons HA, Cropp AM, Silvestri K, Cotter CM, Componeschi KP, Marte JM, Connolly RM, Moy B, Van Poznak CH, Blackwell KL, Puhalla SL, Jankowitz RC, Smith KL, Ibrahim N, Moynihan TJ, O’Sullivan C, Nangia J, Niravath P, Tung N, Pohlmann PR, Burns R, Rimawi MF, Krop IE, Wolff AC, Winer EP, Lin NU, . TBCRC 022: A Phase II Trial of Neratinib and Capecitabine for Patients With Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer and Brain Metastases. Journal Of Clinical Oncology 2019, 37: jco.18.01511. PMID: 30860945, PMCID: PMC6494354, DOI: 10.1200/jco.18.01511.Peer-Reviewed Original ResearchConceptsCNS objective response rateObjective response rateHER2-positive breast cancer brain metastasesBreast cancer brain metastasesCancer brain metastasesBrain metastasesBreast cancerCommon grade 3 toxicitiesHER2-positive brain metastasesMedian progression-free survivalHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Human epidermal growth factor receptorEfficacy of HER2Non-CNS progressionGrade 3 toxicityPrimary end pointPhase II trialProgression-free survivalGrowth factor receptor 2Positive breast cancerProgressive neurologic signsEvidence-based treatmentsFactor receptor 2Epidermal growth factor receptor
2017
Lymphedema, musculoskeletal events and arm function in older patients receiving adjuvant chemotherapy for breast cancer (Alliance A171302)
Hopkins JO, Allred J, Hurria A, Jatoi A, Lafky JM, Cohen H, Hudis C, Winer E, Mandelblatt J, Partridge A, Carey L, Muss HB. Lymphedema, musculoskeletal events and arm function in older patients receiving adjuvant chemotherapy for breast cancer (Alliance A171302). Breast Cancer Research And Treatment 2017, 166: 793-808. PMID: 28825227, PMCID: PMC5771504, DOI: 10.1007/s10549-017-4454-7.Peer-Reviewed Original ResearchConceptsQuality of lifeArm functionBreast cancerAdjuvant chemotherapyMusculoskeletal eventsPhysician-reported adverse eventsIncidence of lymphedemaAxillary node dissectionType of chemotherapyEORTC QLQ-BR23Breast cancer treatmentImpact of treatmentDetection of lymphedemaCALGB 49907Node dissectionAdverse eventsOlder patientsQLQ-BR23Standard therapyStudy entryWomen 65Month 2Elderly womenPatientsChemotherapyT-DM1 — an important agent in the history of breast cancer management
Metzger-Filho O, Winer EP. T-DM1 — an important agent in the history of breast cancer management. Nature Reviews Clinical Oncology 2017, 14: 651-652. PMID: 28786416, DOI: 10.1038/nrclinonc.2017.123.Peer-Reviewed Original ResearchMeSH KeywordsAdo-Trastuzumab EmtansineBreast NeoplasmsCapecitabineHumansLapatinibMaytansineTrastuzumabConceptsT-DM1HER2-positive breast cancerOverall survival benefitFavorable safety profileBreast cancer managementRelevant therapeutic targetTH3RESA trialProlonged followSurvival benefitSafety profileBreast cancerCancer managementTherapeutic targetLater linesImportant agentsPatientsHER2FollowCancerDiseaseTrials
2014
Comorbidity, 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 modelA phase II study of preoperative capecitabine in women with operable hormone receptor positive breast cancer
Tolaney SM, Jeong J, Guo H, Brock J, Morganstern D, Come SE, Golshan M, Bellon J, Winer EP, Krop IE. A phase II study of preoperative capecitabine in women with operable hormone receptor positive breast cancer. Cancer Medicine 2014, 3: 293-299. PMID: 24464780, PMCID: PMC3987079, DOI: 10.1002/cam4.164.Peer-Reviewed Original ResearchConceptsHormone receptor-positive breast cancerReceptor-positive breast cancerPathological complete responsePositive breast cancerBreast cancerPreoperative capecitabineClinical responseHER2-negative operable breast cancerDihydropyrimidine dehydrogenaseOnly grade 3 toxicityOverall clinical response rateThymidine phosphorylaseGrade 3 responsePartial clinical responsePathological response assessmentsPreoperative chemotherapy regimensClinical response rateComplete clinical responseGrade 3 toxicityOperable breast cancerPhase II studyPalmar-plantar erythrodysesthesiaMetastatic breast cancerTime of surgeryMiller-Payne
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 test
2012
Persistence, adherence, and toxicity with oral CMF in older women with early-stage breast cancer (Adherence Companion Study 60104 for CALGB 49907)
Ruddy KJ, Pitcher BN, Archer LE, Cohen HJ, Winer EP, Hudis CA, Muss HB, Partridge AH. Persistence, adherence, and toxicity with oral CMF in older women with early-stage breast cancer (Adherence Companion Study 60104 for CALGB 49907). Annals Of Oncology 2012, 23: 3075-3081. PMID: 22767584, PMCID: PMC3501229, DOI: 10.1093/annonc/mds133.Peer-Reviewed Original ResearchConceptsEarly-stage breast cancerBreast cancerMedication calendarOral cyclophosphamideStandard chemotherapyStage I-IIIB breast cancerSelf-reported adherenceCase report formsToxic effectsAdjuvant chemotherapyCALGB 49907Febrile neutropeniaOral CMFNode negativityOlder patientsStandard therapyMedian ageSuperior tolerabilityRandomized trialsCyclophosphamide dosesAverage adherenceOlder womenCyclophosphamideChemotherapyConsecutive daysA Phase II Study of Trastuzumab Emtansine in Patients With Human Epidermal Growth Factor Receptor 2–Positive Metastatic Breast Cancer Who Were Previously Treated With Trastuzumab, Lapatinib, an Anthracycline, a Taxane, and Capecitabine
Krop IE, LoRusso P, Miller KD, Modi S, Yardley D, Rodriguez G, Guardino E, Lu M, Zheng M, Girish S, Amler L, Winer EP, Rugo HS. A Phase II Study of Trastuzumab Emtansine in Patients With Human Epidermal Growth Factor Receptor 2–Positive Metastatic Breast Cancer Who Were Previously Treated With Trastuzumab, Lapatinib, an Anthracycline, a Taxane, and Capecitabine. Journal Of Clinical Oncology 2012, 30: 3234-3241. PMID: 22649126, DOI: 10.1200/jco.2011.40.5902.Peer-Reviewed Original ResearchMeSH KeywordsAdo-Trastuzumab EmtansineAdultAgedAnthracyclinesAntibodies, Monoclonal, HumanizedAntineoplastic AgentsBreast NeoplasmsBridged-Ring CompoundsCapecitabineDeoxycytidineDisease-Free SurvivalFemaleFluorouracilHumansImmunotoxinsLapatinibMaleMaytansineMiddle AgedMolecular Targeted TherapyNeoplasm MetastasisQuinazolinesReceptor, ErbB-2TaxoidsTrastuzumabConceptsHER2-positive metastatic breast cancerHuman epidermal growth factor receptor 2Metastatic breast cancerProgression-free survivalOverall response rateMedian progression-free survivalPhase II studyT-DM1II studyTrastuzumab emtansineBreast cancerResponse rateSingle-arm phase II studyEpidermal growth factor receptor 2Human epidermal growth factor receptorClinical benefit rateHER2-directed therapiesMost adverse eventsGrowth factor receptor 2Single-agent activityHER2-positive tumorsMultiple chemotherapy agentsEffective new treatmentsFactor receptor 2Epidermal growth factor receptor
2011
Randomized phase II study of lapatinib plus capecitabine or lapatinib plus topotecan for patients with HER2-positive breast cancer brain metastases
Lin NU, Eierman W, Greil R, Campone M, Kaufman B, Steplewski K, Lane SR, Zembryki D, Rubin SD, Winer EP. Randomized phase II study of lapatinib plus capecitabine or lapatinib plus topotecan for patients with HER2-positive breast cancer brain metastases. Journal Of Neuro-Oncology 2011, 105: 613-620. PMID: 21706359, DOI: 10.1007/s11060-011-0629-y.Peer-Reviewed Original ResearchConceptsHER2-positive breast cancerProgressive brain metastasesObjective response rateBrain metastasesTopotecan armBreast cancerHER2-positive breast cancer brain metastasesCentral nervous system progressionBreast cancer brain metastasesRandomized phase II studyCombination of lapatinibPhase II studyCancer brain metastasesEfficacy of lapatinibStandard radiation therapyLack of efficacyNon-CNS lesionsExcess toxicityCapecitabine armRefractory settingCranial radiotherapyPrimary endpointSteroid requirementsII studyObjective responseQuality of Life of Older Patients With Early-Stage Breast Cancer Receiving Adjuvant Chemotherapy: A Companion Study to Cancer and Leukemia Group B 49907
Kornblith AB, Lan L, Archer L, Partridge A, Kimmick G, Hudis C, Winer E, Casey R, Bennett S, Cohen HJ, Muss HB. Quality of Life of Older Patients With Early-Stage Breast Cancer Receiving Adjuvant Chemotherapy: A Companion Study to Cancer and Leukemia Group B 49907. Journal Of Clinical Oncology 2011, 29: 1022-1028. PMID: 21300923, PMCID: PMC3068052, DOI: 10.1200/jco.2010.29.9859.Peer-Reviewed Original ResearchMeSH KeywordsAge FactorsAgedAntimetabolites, AntineoplasticAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCapecitabineChemotherapy, AdjuvantCyclophosphamideDeoxycytidineDisease-Free SurvivalDoxorubicinFemaleFluorouracilHumansMethotrexateNeoplasm StagingQuality of LifeRisk AssessmentRisk FactorsSurveys and QuestionnairesSurvival AnalysisTime FactorsTreatment OutcomeUnited StatesConceptsEarly-stage breast cancerSystemic adverse effectsStandard chemotherapyBreast cancerCapecitabine treatmentOlder patientsOverall survivalStandard treatmentBetter QOLAdverse effectsHand-foot syndromePhase III trialsLife Questionnaire C30Completion of treatmentQuality of lifeAdjuvant chemotherapyLife substudyIII trialsCancer QualityImproved survivalLess nauseaGood appetiteHospital AnxietyDepression ScaleMonths postbaseline
2010
Adherence and Persistence With Oral Adjuvant Chemotherapy in Older Women With Early-Stage Breast Cancer in CALGB 49907: Adherence Companion Study 60104
Partridge AH, Archer L, Kornblith AB, Gralow J, Grenier D, Perez E, Wolff AC, Wang X, Kastrissios H, Berry D, Hudis C, Winer E, Muss H. Adherence and Persistence With Oral Adjuvant Chemotherapy in Older Women With Early-Stage Breast Cancer in CALGB 49907: Adherence Companion Study 60104. Journal Of Clinical Oncology 2010, 28: 2418-2422. PMID: 20368559, PMCID: PMC2881723, DOI: 10.1200/jco.2009.26.4671.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAge FactorsAgedAged, 80 and overAntimetabolites, AntineoplasticBreast NeoplasmsCanadaCapecitabineChemotherapy, AdjuvantDeoxycytidineDrug Administration ScheduleDrug MonitoringFemaleFluorouracilHumansKaplan-Meier EstimateLinear ModelsLogistic ModelsMastectomyMedication AdherenceMicro-Electrical-Mechanical SystemsNeoplasm StagingRisk AssessmentRisk FactorsTime FactorsTreatment OutcomeUnited StatesConceptsEarly-stage breast cancerBreast cancerCALGB 49907Oral chemotherapyClinical trialsOlder womenPatients age 65 yearsOral adjuvant chemotherapyPill bottle openingsNode-negative diseaseHormone receptor statusRelapse-free survivalRandomized clinical trialsAge 65 yearsMulticenter clinical trialNumber of dosesPercent of participantsLogistic regression modelsAdjuvant chemotherapyProtocol therapyOral therapyStandard chemotherapyMedian ageReceptor statusPatient adherence
2009
International Guidelines for Management of Metastatic Breast Cancer: Combination vs Sequential Single-Agent Chemotherapy
Cardoso F, Bedard PL, Winer EP, Pagani O, Senkus-Konefka E, Fallowfield LJ, Kyriakides S, Costa A, Cufer T, Albain KS, Force O. International Guidelines for Management of Metastatic Breast Cancer: Combination vs Sequential Single-Agent Chemotherapy. Journal Of The National Cancer Institute 2009, 101: 1174-1181. PMID: 19657108, PMCID: PMC2736293, DOI: 10.1093/jnci/djp235.Peer-Reviewed Original ResearchMeSH KeywordsAge FactorsAnthracyclinesAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsCapecitabineComorbidityCongresses as TopicCross-Over StudiesDeoxycytidineDrug Administration ScheduleEuropeEvidence-Based MedicineFemaleFluorouracilHumansInternational CooperationKarnofsky Performance StatusMenopausePatient SelectionPractice Guidelines as TopicQuality of LifeRandomized Controlled Trials as TopicSeverity of Illness IndexSocioeconomic FactorsTaxoidsVinblastineVinorelbineConceptsMetastatic breast cancerSequential single-agent chemotherapySingle-agent chemotherapyBreast cancerEarly-stage breast cancerEuropean Breast Cancer ConferenceSequential single agentsPatient-rated qualityRapid clinical progressionDisease-related factorsImpact of therapySequential monotherapyAdvanced diseaseSequential therapyVisceral metastasesCytotoxic chemotherapyTask ForceClinical progressionPredictive factorsTreatment optionsCancer ConferenceRapid symptomsSingle agentChemotherapyInternational guidelinesAdjuvant Chemotherapy in Older Women with Early-Stage Breast Cancer
Muss HB, Berry DA, Cirrincione CT, Theodoulou M, Mauer AM, Kornblith AB, Partridge AH, Dressler LG, Cohen HJ, Becker HP, Kartcheske PA, Wheeler JD, Perez EA, Wolff AC, Gralow JR, Burstein HJ, Mahmood AA, Magrinat G, Parker BA, Hart RD, Grenier D, Norton L, Hudis CA, Winer EP. Adjuvant Chemotherapy in Older Women with Early-Stage Breast Cancer. New England Journal Of Medicine 2009, 360: 2055-2065. PMID: 19439741, PMCID: PMC3082436, DOI: 10.1056/nejmoa0810266.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overAntimetabolites, AntineoplasticAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCapecitabineChemotherapy, AdjuvantCisplatinCyclophosphamideDeoxycytidineDoxorubicinFemaleFluorouracilHumansKaplan-Meier EstimateMaleMethotrexateNeoplasm MetastasisNeoplasm Recurrence, LocalNeoplasm StagingReceptors, EstrogenSurvival AnalysisConceptsEarly-stage breast cancerRelapse-free survivalStandard chemotherapyBreast cancerCapecitabine groupAdjuvant chemotherapyYears of ageOlder womenIIIB breast cancerStandard chemotherapy groupPrimary end pointStandard adjuvant chemotherapyTreatment-related complicationsOverall survival rateSevere toxic effectsCapecitabine therapyEndocrine therapyHazard ratioDisease recurrenceSuch patientsLong followPositive tumorsClinical trialsChemotherapyPatientsTolerability of and adherence to combination oral therapy with gefitinib and capecitabine in metastatic breast cancer
Mayer EL, Partridge AH, Harris LN, Gelman RS, Schumer ST, Burstein HJ, Winer EP. Tolerability of and adherence to combination oral therapy with gefitinib and capecitabine in metastatic breast cancer. Breast Cancer Research And Treatment 2009, 117: 615-623. PMID: 19294501, PMCID: PMC4578795, DOI: 10.1007/s10549-009-0366-5.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerStable diseaseValidation cohortBreast cancerSequential cohortsPhase ICombination oral therapyOral antineoplastic therapyDays on/7Primary endpointSecondary endpointsOral therapyPartial responseAntineoplastic therapySerious toxicityDose reductionDrug dosesM2/dayCohortSignificant toxicityPatientsTherapyMTDCycle 1Capecitabine