2022
Overall Survival with Ribociclib plus Letrozole in Advanced Breast Cancer
Hortobagyi GN, Stemmer SM, Burris HA, Yap YS, Sonke GS, Hart L, Campone M, Petrakova K, Winer EP, Janni W, Conte P, Cameron DA, André F, Arteaga CL, Zarate JP, Chakravartty A, Taran T, Le Gac F, Serra P, O'Shaughnessy J. Overall Survival with Ribociclib plus Letrozole in Advanced Breast Cancer. New England Journal Of Medicine 2022, 386: 942-950. PMID: 35263519, DOI: 10.1056/nejmoa2114663.Peer-Reviewed Original ResearchConceptsAdvanced breast cancerSignificant overall survival benefitMedian overall survivalOverall survival benefitProgression-free survivalOverall survivalBreast cancerSurvival benefitHER2-negative advanced breast cancerKey secondary end pointProtocol-specified final analysisLonger progression-free survivalHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Negative advanced breast cancerStratified log-rank testFirst-line ribociclibSecondary end pointsFirst-line therapyNew safety signalsPhase 3 trialGrowth factor receptor 2Kaplan-Meier methodLog-rank testFactor receptor 2
2019
Clinical significance of circulating tumor cells (CTCs) in hormone receptor-positive (HR+) metastatic breast cancer (MBC) patients (pts) receiving letrozole (Let) or Let plus bevacizumab (Bev): CALGB 40503 (Alliance).
Magbanua M, Oleksandr Savenkov O, Asmus E, Ballman K, Scott J, Park J, Dickler M, Partridge A, Carey L, Winer E, Rugo H. Clinical significance of circulating tumor cells (CTCs) in hormone receptor-positive (HR+) metastatic breast cancer (MBC) patients (pts) receiving letrozole (Let) or Let plus bevacizumab (Bev): CALGB 40503 (Alliance). Journal Of Clinical Oncology 2019, 37: 1049-1049. DOI: 10.1200/jco.2019.37.15_suppl.1049.Peer-Reviewed Original ResearchProgression-free survivalOverall survivalCTC statusHormone receptor-positive metastatic breast cancer patientsPredictive valueLonger median progression-free survivalImproved progression-free survivalMedian progression-free survivalMetastatic breast cancer patientsWorse progression-free survivalAddition of BevFirst-line therapyCox regression analysisEarly breast cancerInitiation of treatmentBreast cancer patientsPotential predictive valueML of bloodMetastatic diseaseMultivariable analysisCancer patientsClinical significanceBreast cancerUS FDATumor cellsPembrolizumab monotherapy for previously untreated, PD-L1-positive, metastatic triple-negative breast cancer: cohort B of the phase II KEYNOTE-086 study
Adams S, Loi S, Toppmeyer D, Cescon DW, De Laurentiis M, Nanda R, Winer EP, Mukai H, Tamura K, Armstrong A, Liu MC, Iwata H, Ryvo L, Wimberger P, Rugo HS, Tan AR, Jia L, Ding Y, Karantza V, Schmid P. Pembrolizumab monotherapy for previously untreated, PD-L1-positive, metastatic triple-negative breast cancer: cohort B of the phase II KEYNOTE-086 study. Annals Of Oncology 2019, 30: 405-411. PMID: 30475947, DOI: 10.1093/annonc/mdy518.Peer-Reviewed Original ResearchConceptsMetastatic triple-negative breast cancerPositive metastatic triple-negative breast cancerTreatment-related adverse eventsTriple-negative breast cancerDisease control rateObjective response rateFirst-line therapyProgression-free survivalAdverse eventsPD-L1Stable diseasePembrolizumab monotherapyOverall survivalCohort BControl rateBreast cancerResponse ratePD-L1 combined positive scoreCentral nervous system metastasesGrade 4 adverse eventsMedian progression-free survivalStandard first-line treatmentEnd pointGrade 3 severityManageable safety profile
2018
Systemic Therapy for Patients With Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: ASCO Clinical Practice Guideline Update
Giordano SH, Temin S, Chandarlapaty S, Crews JR, Esteva FJ, Kirshner JJ, Krop IE, Levinson J, Lin NU, Modi S, Patt DA, Perlmutter J, Ramakrishna N, Winer EP, Davidson NE. Systemic Therapy for Patients With Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: ASCO Clinical Practice Guideline Update. Journal Of Clinical Oncology 2018, 36: jco.2018.79.269. PMID: 29939838, DOI: 10.1200/jco.2018.79.2697.Peer-Reviewed Original ResearchConceptsAdvanced breast cancerBreast cancerSystemic therapyTrastuzumab emtansineEstrogen receptor-positive/progesterone receptor-positive breast cancerAdvanced human epidermal growth factor receptorASCO Clinical Practice Guideline UpdateHER2-positive advanced breast cancerProgesterone receptor-positive breast cancerClinical congestive heart failureClinical Practice Guideline UpdateEvidence-based guideline recommendationsStandard first-line therapyPositive advanced breast cancerLeft ventricular ejection fractionReceptor-positive breast cancerHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Human epidermal growth factor receptorThird-line settingSecond-line treatmentFirst-line therapyFirst-line treatmentProgression-free survivalTime of progressionVariation in guideline-concordant care for elderly patients with metastatic breast cancer in the United States
Poorvu PD, Vaz-Luis I, Freedman RA, Lin NU, Barry WT, Winer EP, Hassett MJ. Variation in guideline-concordant care for elderly patients with metastatic breast cancer in the United States. Breast Cancer Research And Treatment 2018, 168: 727-737. PMID: 29332137, DOI: 10.1007/s10549-018-4659-4.Peer-Reviewed Original ResearchConceptsInitial systemic therapyMetastatic breast cancerSystemic therapyBreast cancerDe novo metastatic breast cancerNovo metastatic breast cancerEarly-stage breast cancerHuman epidermal receptor 2HR-positive patientsInitial systemic treatmentGuideline-concordant careHER2-positive patientsFirst-line therapyTriple-negative tumorsPatterns of careQuality of careGuideline concordanceInitial therapyMBC cohortUntreated patientsElderly patientsMost patientsSystemic treatmentInitial treatmentHospice utilization
2017
Phase 2 study of pembrolizumab as first-line therapy for PD-L1–positive metastatic triple-negative breast cancer (mTNBC): Preliminary data from KEYNOTE-086 cohort B.
Adams S, Loi S, Toppmeyer D, Cescon D, De Laurentiis M, Nanda R, Winer E, Mukai H, Tamura K, Armstrong A, Liu M, Iwata H, Ryvo L, Wimberger P, Card D, Ding Y, Karantza V, Schmid P. Phase 2 study of pembrolizumab as first-line therapy for PD-L1–positive metastatic triple-negative breast cancer (mTNBC): Preliminary data from KEYNOTE-086 cohort B. Journal Of Clinical Oncology 2017, 35: 1088-1088. DOI: 10.1200/jco.2017.35.15_suppl.1088.Peer-Reviewed Original ResearchMetastatic triple-negative breast cancerPositive metastatic triple-negative breast cancerFirst-line therapyCombined positive scorePD-L1 combined positive scoreTreatment-related AEsPD-L1Cohort BStandard first-line treatmentEnd pointTriple-negative breast cancerECOG PS 0Antitumor activityManageable safety profilePrimary end pointSecondary end pointsFirst-line treatmentPhase 2 studySystemic anticancer therapyNew treatment optionsBest overall responseMedian DoRMedian PFSPFS ratesIntolerable toxicity
2015
Randomized Phase III Trial of Paclitaxel Once Per Week Compared With Nanoparticle Albumin-Bound Nab-Paclitaxel Once Per Week or Ixabepilone With Bevacizumab As First-Line Chemotherapy for Locally Recurrent or Metastatic Breast Cancer: CALGB 40502/NCCTG N063H (Alliance)
Rugo HS, Barry WT, Moreno-Aspitia A, Lyss AP, Cirrincione C, Leung E, Mayer EL, Naughton M, Toppmeyer D, Carey LA, Perez EA, Hudis C, Winer EP. Randomized Phase III Trial of Paclitaxel Once Per Week Compared With Nanoparticle Albumin-Bound Nab-Paclitaxel Once Per Week or Ixabepilone With Bevacizumab As First-Line Chemotherapy for Locally Recurrent or Metastatic Breast Cancer: CALGB 40502/NCCTG N063H (Alliance). Journal Of Clinical Oncology 2015, 33: 2361-2369. PMID: 26056183, PMCID: PMC4500830, DOI: 10.1200/jco.2014.59.5298.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAlbuminsAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabBreast NeoplasmsDrug Administration ScheduleEpothilonesFemaleHumansMiddle AgedNanoparticlesNeoplasm MetastasisNeoplasm Recurrence, LocalPaclitaxelTreatment OutcomeConceptsAdvanced breast cancerProgression-free survivalNab-paclitaxelBreast cancerInterim analysisMedian progression-free survivalRandomized phase III trialEarly dose reductionSecond interim analysisFirst-line therapyPhase III trialsMetastatic breast cancerFirst interim analysisEligible patientsLine chemotherapyNonhematologic toxicityPalliative chemotherapyHazard ratioIII trialsOverall survivalPeripheral neuropathyTreatment failureExperimental armLocally RecurrentArm C
2014
Systemic Therapy for Patients With Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline
Giordano SH, Temin S, Kirshner JJ, Chandarlapaty S, Crews JR, Davidson NE, Esteva FJ, Gonzalez-Angulo AM, Krop I, Levinson J, Lin NU, Modi S, Patt DA, Perez EA, Perlmutter J, Ramakrishna N, Winer EP. Systemic Therapy for Patients With Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline. Journal Of Clinical Oncology 2014, 32: 2078-2099. PMID: 24799465, PMCID: PMC6076031, DOI: 10.1200/jco.2013.54.0948.Peer-Reviewed Original ResearchMeSH KeywordsAdo-Trastuzumab EmtansineAnastrozoleAntibodies, Monoclonal, HumanizedAntineoplastic Agents, HormonalAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsClinical Trials as TopicComorbidityDocetaxelDrug Administration ScheduleEvidence-Based MedicineFemaleHealth Status DisparitiesHealthcare DisparitiesHumansLapatinibLetrozoleMaytansineMolecular Targeted TherapyNitrilesQuinazolinesReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneSocieties, MedicalTaxoidsTrastuzumabTreatment OutcomeTriazolesUnited StatesConceptsAdvanced breast cancerHuman epidermal growth factor receptorSecond-line treatmentProgression-free survivalFirst-line treatmentBreast cancerPFS benefitT-DM1Epidermal growth factor receptorEndocrine therapyGrowth factor receptorSystemic therapyEstrogen receptor-positive/progesterone receptor-positive breast cancerAdvanced human epidermal growth factor receptorHER2-positive advanced breast cancerProgesterone receptor-positive breast cancerClinical Oncology Clinical Practice GuidelineClinical congestive heart failureStandard first-line therapyPositive advanced breast cancerLeft ventricular ejection fractionOncology Clinical Practice GuidelineReceptor-positive breast cancerThird-line settingFirst-line therapy
2012
CALGB 40502/NCCTG N063H: Randomized phase III trial of weekly paclitaxel (P) compared to weekly nanoparticle albumin bound nab-paclitaxel (NP) or ixabepilone (Ix) with or without bevacizumab (B) as first-line therapy for locally recurrent or metastatic breast cancer (MBC).
Rugo H, Barry W, Moreno-Aspitia A, Lyss A, Cirrincione C, Mayer E, Naughton M, Layman R, Carey L, Somer R, Perez E, Hudis C, Winer E. CALGB 40502/NCCTG N063H: Randomized phase III trial of weekly paclitaxel (P) compared to weekly nanoparticle albumin bound nab-paclitaxel (NP) or ixabepilone (Ix) with or without bevacizumab (B) as first-line therapy for locally recurrent or metastatic breast cancer (MBC). Journal Of Clinical Oncology 2012, 30: cra1002-cra1002. DOI: 10.1200/jco.2012.30.18_suppl.cra1002.Peer-Reviewed Original ResearchProgression-free survivalMetastatic breast cancerNab-paclitaxelPhase III trialsSensory neuropathyHazard ratioIII trialsInterim analysisGrade 2 sensory neuropathyMedian progression-free survivalAlbumin-bound formulationWeekly nanoparticle albuminPrimary end pointFirst-line therapyHormone receptor statusCause deathMeasurable diseaseWeek dosingWeekly paclitaxelHematologic toxicityFree survivalReceptor statusTaxane useExperimental armNanoparticle albuminCALGB 40502/NCCTG N063H: Randomized phase III trial of weekly paclitaxel (P) compared to weekly nanoparticle albumin bound nab-paclitaxel (NP) or ixabepilone (Ix) with or without bevacizumab (B) as first-line therapy for locally recurrent or metastatic breast cancer (MBC).
Rugo H, Barry W, Moreno-Aspitia A, Lyss A, Cirrincione C, Mayer E, Naughton M, Layman R, Carey L, Somer R, Perez E, Hudis C, Winer E. CALGB 40502/NCCTG N063H: Randomized phase III trial of weekly paclitaxel (P) compared to weekly nanoparticle albumin bound nab-paclitaxel (NP) or ixabepilone (Ix) with or without bevacizumab (B) as first-line therapy for locally recurrent or metastatic breast cancer (MBC). Journal Of Clinical Oncology 2012, 30: cra1002-cra1002. DOI: 10.1200/jco.2012.30.15_suppl.cra1002.Peer-Reviewed Original Research
2011
P3-16-05: A Phase II Trial Expansion Cohort of the PARP Inhibitor Veliparib (ABT888) and Temozolomide in BRCA1/2 Associated Metastatic Breast Cancer.
Isakoff S, Overmoyer B, Tung N, Gelman R, Habin K, Qian J, Giranda V, Shepherd S, Garber J, Ellisen L, Winer E, Goss P. P3-16-05: A Phase II Trial Expansion Cohort of the PARP Inhibitor Veliparib (ABT888) and Temozolomide in BRCA1/2 Associated Metastatic Breast Cancer. Cancer Research 2011, 71: p3-16-05-p3-16-05. DOI: 10.1158/0008-5472.sabcs11-p3-16-05.Peer-Reviewed Original ResearchMetastatic breast cancerClinical benefit ratePrior platinum treatmentExpansion cohortResponse rateBenefit ratePlatinum treatmentPo bidPrior platinumMedian PFSAdditional patientsOriginal cohortBreast cancerCommon grade 3/4 toxicitiesSingle-arm phase II trialArm phase II trialBreast cancer xenograft modelPARP inhibitor veliparibPrior adjuvant chemotherapySafety of temozolomideGrade 3/4 toxicitiesPhase II studyFirst-line therapyPhase II trialOverall response ratePaclitaxel efficacy and toxicity in older women with metastatic breast cancer: combined analysis of CALGB 9342 and 9840
Lichtman S, Hurria A, Cirrincione C, Seidman A, Winer E, Hudis C, Cohen H, Muss H, B F. Paclitaxel efficacy and toxicity in older women with metastatic breast cancer: combined analysis of CALGB 9342 and 9840. Annals Of Oncology 2011, 23: 632-638. PMID: 21693770, PMCID: PMC3331731, DOI: 10.1093/annonc/mdr297.Peer-Reviewed Original ResearchConceptsProgression-free survivalGood performance statusFirst-line therapyMetastatic breast cancerOverall survivalPerformance statusBreast cancerOlder womenLeukemia Group B StudySecond-line therapyImproved overall survivalDoses of paclitaxelEstrogen receptor-positive statusTolerability of paclitaxelToxic effectsBilirubin elevationPaclitaxel efficacyWeekly paclitaxelOlder patientsMetastatic sitesTumor responseSimilar efficacyPositive statusSpecific toxic effectsPatients
2009
Paclitaxel in older women with breast cancer. Combined analysis of CALGB 9342 and 9840 with a focus on age.
Lichtman S, Hurria A, Cirrincione C, Seidman A, Winer E, Hudis C, Cohen H, Muss H. Paclitaxel in older women with breast cancer. Combined analysis of CALGB 9342 and 9840 with a focus on age. Cancer Research 2009, 69: 6112. DOI: 10.1158/0008-5472.sabcs-6112.Peer-Reviewed Original ResearchFirst-line therapyLines of therapyBreast cancerPatient ageOlder womenSide effectsLine therapyOlder adultsIncidence of gradeOnset of gradePrior chemotherapy regimenSecond-line patientsSingle-agent paclitaxelDoses of paclitaxelMetastatic breast cancerOnset of neurotoxicityRisk of fallsStandard prognostic variablesAge categoriesLikelihood of responseBetter performance scoresPerformance scoresBilirubin elevationPaclitaxel efficacyWeekly paclitaxel
2007
Trastuzumab plus vinorelbine or taxane chemotherapy for HER2‐overexpressing metastatic breast cancer: The trastuzumab and vinorelbine or taxane study
Burstein HJ, Keshaviah A, Baron AD, Hart RD, Lambert‐Falls R, Marcom PK, Gelman R, Winer EP. Trastuzumab plus vinorelbine or taxane chemotherapy for HER2‐overexpressing metastatic breast cancer: The trastuzumab and vinorelbine or taxane study. Cancer 2007, 110: 965-972. PMID: 17614302, DOI: 10.1002/cncr.22885.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAlopeciaAnemiaAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsConstipationDisease ProgressionDrug Administration ScheduleFatigueFemaleHumansKaplan-Meier EstimateMiddle AgedNauseaNeoplasm MetastasisPaclitaxelProspective StudiesReceptor, ErbB-2TrastuzumabTreatment OutcomeVinblastineVinorelbineConceptsMetastatic breast cancerBreast cancerTrastuzumab armEpisodes of cardiotoxicityFirst-line therapyDermatologic toxicitiesEvaluable patientsPrior chemotherapyVinorelbine therapyAdvanced diseaseChemotherapy regimenEligible patientsGastrointestinal toxicityPoor accrualTaxane chemotherapyTaxane therapyMore anemiaMedian timeTrastuzumab treatmentFluid retentionDisease progressionChemotherapy agentsTreatment decisionsVinorelbineSide effects
2003
Trastuzumab and vinorelbine as first-line therapy for HER2-overexpressing metastatic breast cancer: multicenter phase II trial with clinical outcomes, analysis of serum tumor markers as predictive factors, and cardiac surveillance algorithm.
Burstein HJ, Harris LN, Marcom PK, Lambert-Falls R, Havlin K, Overmoyer B, Friedlander RJ, Gargiulo J, Strenger R, Vogel CL, Ryan PD, Ellis MJ, Nunes RA, Bunnell CA, Campos SM, Hallor M, Gelman R, Winer EP. Trastuzumab and vinorelbine as first-line therapy for HER2-overexpressing metastatic breast cancer: multicenter phase II trial with clinical outcomes, analysis of serum tumor markers as predictive factors, and cardiac surveillance algorithm. Journal Of Clinical Oncology 2003, 21: 2889-95. PMID: 12885806, DOI: 10.1200/jco.2003.02.018.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAlgorithmsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsDisease ProgressionFemaleHeart DiseasesHumansInfusions, IntravenousMiddle AgedPredictive Value of TestsReceptor, ErbB-2ROC CurveSurvival AnalysisTrastuzumabTreatment OutcomeVinblastineVinorelbineConceptsLeft ventricular ejection fractionMetastatic breast cancerHER2-positive metastatic breast cancerBreast cancerHER2 extracellular domainResponse rateEjection fractionTumor markersNormal left ventricular ejection fractionMulticenter phase II studyMulticenter phase II trialPositive advanced breast cancerHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Prior adjuvant chemotherapySafety of trastuzumabFirst-line chemotherapyPhase II studySymptomatic heart failureAdvanced breast cancerBaseline ejection fractionFirst-line therapyFirst-line treatmentPhase II trialTrastuzumab-based therapyCentral nervous system metastases in women who receive trastuzumab‐based therapy for metastatic breast carcinoma
Bendell JC, Domchek SM, Burstein HJ, Harris L, Younger J, Kuter I, Bunnell C, Rue M, Gelman R, Winer E. Central nervous system metastases in women who receive trastuzumab‐based therapy for metastatic breast carcinoma. Cancer 2003, 97: 2972-2977. PMID: 12784331, DOI: 10.1002/cncr.11436.Peer-Reviewed Original ResearchConceptsPercent of patientsMetastatic breast carcinomaTrastuzumab-based therapyCentral nervous system metastasesCentral nervous system diseaseNervous system metastasesCNS diseaseNervous system diseasesBreast carcinomaBrain metastasesCNS metastasesLeptomeningeal involvementSystem diseasesDisease sitesMore brain metastasesParenchymal brain metastasesProgressive CNS diseaseFirst-line therapyTime of diagnosisMedian survival periodBlood-brain barrierNew treatment strategiesStable diseaseMetastatic diseasePharmacy records
2001
Liposome‐encapsulated doxorubicin compared with conventional doxorubicin in a randomized multicenter trial as first‐line therapy of metastatic breast carcinoma
Harris L, Batist G, Belt R, Rovira D, Navari R, Azarnia N, Welles L, Winer E, Group T. Liposome‐encapsulated doxorubicin compared with conventional doxorubicin in a randomized multicenter trial as first‐line therapy of metastatic breast carcinoma. Cancer 2001, 94: 25-36. PMID: 11815957, DOI: 10.1002/cncr.10201.Peer-Reviewed Original ResearchConceptsLeft ventricular ejection fractionMetastatic breast carcinomaClinical congestive heart failureTLC DConventional doxorubicinBreast carcinomaTreatment groupsResponse rateMedian cumulative doxorubicin doseProgesterone receptor-positive patientsWorld Health Organization criteriaCumulative doxorubicin doseOnset of cardiotoxicityPrimary safety endpointReceptor-positive patientsPrimary efficacy endpointRandomized multicenter trialFirst-line therapyFirst-line treatmentPalmar-plantar erythrodysesthesiaCongestive heart failureRelevant prognostic factorsVentricular ejection fractionOverall response rateComparable antitumor activityClinical activity of trastuzumab and vinorelbine in women with HER2-overexpressing metastatic breast cancer.
Burstein H, Kuter I, Campos S, Gelman R, Tribou L, Parker L, Manola J, Younger J, Matulonis U, Bunnell C, Partridge A, Richardson P, Clarke K, Shulman L, Winer E. Clinical activity of trastuzumab and vinorelbine in women with HER2-overexpressing metastatic breast cancer. Journal Of Clinical Oncology 2001, 19: 2722-30. PMID: 11352965, DOI: 10.1200/jco.2001.19.10.2722.Peer-Reviewed Original ResearchConceptsGrade 2 cardiac toxicityAdvanced breast cancerBreast cancerResponse rateCardiac toxicityHER2-overexpressing metastatic breast cancerOnly grade 4 toxicityHER2-positive breast cancerCumulative doxorubicin doseGrade 4 toxicityStudy of trastuzumabSymptomatic heart failureThird-line therapyFirst-line therapyType of chemotherapyMetastatic breast cancerPercent of womenHigh response rateConcurrent trastuzumabPrior chemotherapyWeekly vinorelbineMetastatic diseasePositive patientsHeart failureDoxorubicin dose
1999
Vinorelbine as first-line chemotherapy for advanced breast cancer in women 60 years of age or older
Vogel C, O’Rourke M, Winer E, Hochster H, Chang A, Adamkiewicz B, White R, McGuirt C. Vinorelbine as first-line chemotherapy for advanced breast cancer in women 60 years of age or older. Annals Of Oncology 1999, 10: 397-402. PMID: 10370781, DOI: 10.1023/a:1008364222793.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overAgingAntineoplastic Agents, PhytogenicBreast NeoplasmsDisease-Free SurvivalDose-Response Relationship, DrugDrug Administration ScheduleFemaleFollow-Up StudiesHumansInfusions, IntravenousMiddle AgedProspective StudiesSeverity of Illness IndexTreatment OutcomeVinblastineVinorelbineConceptsAdvanced breast cancerDose-limiting toxicityBreast cancerSide effectsNonhematologic toxicityElderly patientsMeasurable advanced breast cancerMajor dose-limiting toxicityActivity of vinorelbineMedian dose intensityFirst-line chemotherapyObjective response rateFirst-line therapyPhase II trialSubjective side effectsInjection site reactionsWomen 60 yearsGastrointestinal side effectsGeneralized painIntravenous vinorelbinePrior chemotherapyAbdominal painChest painII trialCytotoxic chemotherapy
1996
Continuous infusion 5-fluorouracil as first-line therapy for metastatic breast cancer.
Chu L, Sutton LM, Peterson BL, Havlin KA, Winer EP. Continuous infusion 5-fluorouracil as first-line therapy for metastatic breast cancer. The Journal Of Infusional Chemotherapy 1996, 6: 211-6. PMID: 9229318.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerSymptom Distress ScaleFunctional Living Index-CancerFirst-line settingFirst-line therapyBreast cancerContinuous infusionDisease progressionPrevious phase II studyRefractory metastatic breast cancerAdequate bone marrowContinuous infusion fluorouracilGrade 3 mucositisECOG performance statusMedian overall survivalObjective response ratePhase II studyContinuous intravenous infusionQuality of lifeEvaluable diseaseFLIC scoresInfusion fluorouracilMeasurable diseasePrior chemotherapyIndex cancer