2019
Randomized 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 rates
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 womenPatientsChemotherapy
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 testPAM50 proliferation score as a predictor of weekly paclitaxel benefit in breast cancer
Martín M, Prat A, Rodríguez-Lescure Á, Caballero R, Ebbert MT, Munárriz B, Ruiz-Borrego M, Bastien RR, Crespo C, Davis C, Rodríguez CA, López-Vega JM, Furió V, García AM, Casas M, Ellis MJ, Berry DA, Pitcher BN, Harris L, Ruiz A, Winer E, Hudis C, Stijleman IJ, Tuck DP, Carrasco E, Perou CM, Bernard PS. PAM50 proliferation score as a predictor of weekly paclitaxel benefit in breast cancer. Breast Cancer Research And Treatment 2013, 138: 457-466. PMID: 23423445, PMCID: PMC3608881, DOI: 10.1007/s10549-013-2416-2.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCell ProliferationClinical Trials, Phase III as TopicCyclophosphamideEpirubicinFemaleFluorouracilHumansKaplan-Meier EstimateKi-67 AntigenMiddle AgedMulticenter Studies as TopicMultivariate AnalysisPaclitaxelProportional Hazards ModelsProspective StudiesRandomized Controlled Trials as TopicTreatment OutcomeConceptsGroup of patientsWeekly paclitaxelOverall survivalPAM50 subtypesProliferation scoreBreast cancerNode-positive operable breast cancerMultivariable Cox regression analysisLow proliferation statusAnthracycline-containing chemotherapyOperable breast cancerPhase III trialsSubset of patientsCox regression analysisClinical-pathological variablesFEC armMedian followAdjuvant therapySecondary endpointsIII trialsPathological variablesHistologic gradeClinical trialsAdjuvant FECKi-67
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
CMF revisited in the 21st century
Munzone E, Curigliano G, Burstein HJ, Winer EP, Goldhirsch A. CMF revisited in the 21st century. Annals Of Oncology 2011, 23: 305-311. PMID: 21715566, DOI: 10.1093/annonc/mdr309.Peer-Reviewed Original ResearchConceptsTriple-negative breast cancerBreast cancerClassical CMFOptimal chemotherapy backboneRecent retrospective dataUse of CMFTreatment of patientsTriple negative cellsPoly (ADP-ribose) polymerase (PARP) inhibitorsMechanism of actionAdjuvant CMFChemotherapy backboneAdjuvant treatmentRetrospective dataSpecific subgroupsPolymerase inhibitorsCancerTrue effectivenessPatientsCMFPlatinum compoundsDrugsTreatmentPast yearYearsRandomized 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
Prognostic and predictive value of the 21-gene recurrence score assay in postmenopausal women with node-positive, oestrogen-receptor-positive breast cancer on chemotherapy: a retrospective analysis of a randomised trial
Albain KS, Barlow WE, Shak S, Hortobagyi GN, Livingston RB, Yeh IT, Ravdin P, Bugarini R, Baehner FL, Davidson NE, Sledge GW, Winer EP, Hudis C, Ingle JN, Perez EA, Pritchard KI, Shepherd L, Gralow JR, Yoshizawa C, Allred DC, Osborne CK, Hayes DF, America F. Prognostic and predictive value of the 21-gene recurrence score assay in postmenopausal women with node-positive, oestrogen-receptor-positive breast cancer on chemotherapy: a retrospective analysis of a randomised trial. The Lancet Oncology 2009, 11: 55-65. PMID: 20005174, PMCID: PMC3058239, DOI: 10.1016/s1470-2045(09)70314-6.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsClinical Trials, Phase III as TopicCyclophosphamideDisease-Free SurvivalDoxorubicinFemaleFluorouracilGene Expression ProfilingGene Expression Regulation, NeoplasticGenetic TestingHumansKaplan-Meier EstimateLymphatic MetastasisMiddle AgedPatient SelectionPostmenopausePredictive Value of TestsProportional Hazards ModelsRandomized Controlled Trials as TopicReceptors, EstrogenRecurrenceRetrospective StudiesReverse Transcriptase Polymerase Chain ReactionRisk AssessmentTamoxifenTime FactorsTreatment OutcomeUnited StatesConceptsLow recurrence scorePositive breast cancerAnthracycline-based chemotherapyDisease-free survivalHigh recurrence scoreRecurrence scorePositive nodesBreast cancerPostmenopausal womenRetrospective analysisNode-positive breast cancerTamoxifen-alone groupTamoxifen-treated patientsPhase 3 trialNational Cancer InstituteEffect of recurrenceOverall survivalSpecific survivalSurvival benefitCox regressionHigh riskTreatment groupsCancer InstituteChemotherapyPredictive valueInternational 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 guidelinesTopoisomerase IIα Amplification Does Not Predict Benefit From Dose-Intense Cyclophosphamide, Doxorubicin, and Fluorouracil Therapy in HER2-Amplified Early Breast Cancer: Results of CALGB 8541/150013
Harris LN, Broadwater G, Abu-Khalaf M, Cowan D, Thor AD, Budman D, Cirrincione CT, Berry DA, Winer EP, Hudis CA, Hayes DF, Friedman P, Ellis M, Dressler L. Topoisomerase IIα Amplification Does Not Predict Benefit From Dose-Intense Cyclophosphamide, Doxorubicin, and Fluorouracil Therapy in HER2-Amplified Early Breast Cancer: Results of CALGB 8541/150013. Journal Of Clinical Oncology 2009, 27: 3430-3436. PMID: 19470942, PMCID: PMC4979079, DOI: 10.1200/jco.2008.18.4085.Peer-Reviewed Original ResearchMeSH KeywordsAnthracyclinesAntibiotics, AntineoplasticAntigens, NeoplasmAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsCyclophosphamideDNA Topoisomerases, Type IIDNA-Binding ProteinsDoxorubicinDrug InteractionsFluorouracilGene AmplificationHumansImmunohistochemistryReceptor, ErbB-2Adjuvant 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 1CapecitabineMulticenter Phase II Study of Lapatinib in Patients with Brain Metastases from HER2-Positive Breast Cancer
Lin N, Diéras V, Paul D, Lossignol D, Christodoulou C, Stemmler H, Roché H, Liu M, Greil R, Ciruelos E, Loibl S, Gori S, Wardley A, Yardley D, Brufsky A, Blum J, Rubin S, Dharan B, Steplewski K, Zembryki D, Oliva C, Roychowdhury D, Paoletti P, Winer E. Multicenter Phase II Study of Lapatinib in Patients with Brain Metastases from HER2-Positive Breast Cancer. Clinical Cancer Research 2009, 15: 1452-1459. PMID: 19228746, DOI: 10.1158/1078-0432.ccr-08-1080.Peer-Reviewed Original ResearchConceptsBrain metastasesBreast cancerObjective responseVolumetric reductionCNS lesionsNeurologic signsCentral nervous system progressionMulticenter phase II studySmall phase 2 trialHER2-positive breast cancerCombination of lapatinibExtra-CNS diseaseProgressive brain metastasesPhase II studyPrimary end pointPhase 2 trialProgression-free survivalThird of patientsProgressive neurologic signsMajor clinical challengeCNS metastasesCranial radiationEligible patientsEvaluable patientsPrior trastuzumab
2008
Efficacy and safety of erlotinib in patients with locally advanced or metastatic breast cancer
Dickler MN, Cobleigh MA, Miller KD, Klein PM, Winer EP. Efficacy and safety of erlotinib in patients with locally advanced or metastatic breast cancer. Breast Cancer Research And Treatment 2008, 115: 115-121. PMID: 18496750, DOI: 10.1007/s10549-008-0055-9.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAnthracyclinesAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCapecitabineCohort StudiesDeoxycytidineDisease ProgressionErbB ReceptorsErlotinib HydrochlorideFemaleFluorouracilHumansMiddle AgedNeoplasm MetastasisProtein Kinase InhibitorsQuinazolinesTaxoidsConceptsAdvanced breast cancerSafety of erlotinibBreast cancerCohort 1 patientsCohort 2 patientsResults One patientCommon adverse eventsPhase II studyAdvanced stage diseaseMetastatic breast cancerBreast cancer patientsPrimary endpointSecondary endpointsAdverse eventsII studyPartial responseMedian timePredictive factorsCancer patientsErlotinib treatmentCohort 2Cohort 1Design MulticenterOne patientDry skinTen years of HER2-directed therapy: still questions after all these years
Krop IE, Winer EP. Ten years of HER2-directed therapy: still questions after all these years. Breast Cancer Research And Treatment 2008, 113: 207-209. PMID: 18463974, DOI: 10.1007/s10549-008-0041-2.Peer-Reviewed Original ResearchAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCapecitabineClinical Trials, Phase III as TopicDeoxycytidineDisease-Free SurvivalDrug Delivery SystemsDrug Resistance, NeoplasmErbB ReceptorsFemaleFluorouracilForecastingHumansLapatinibNeoplasm ProteinsProtein Kinase InhibitorsQuinazolinesRandomized Controlled Trials as TopicReceptor, ErbB-2Trastuzumab