2012
Combination antiangiogenic therapy in advanced breast cancer: a phase 1 trial of vandetanib, a VEGFR inhibitor, and metronomic chemotherapy, with correlative platelet proteomics
Mayer EL, Isakoff SJ, Klement G, Downing SR, Chen WY, Hannagan K, Gelman R, Winer EP, Burstein HJ. Combination antiangiogenic therapy in advanced breast cancer: a phase 1 trial of vandetanib, a VEGFR inhibitor, and metronomic chemotherapy, with correlative platelet proteomics. Breast Cancer Research And Treatment 2012, 136: 169-178. PMID: 23001754, PMCID: PMC5472381, DOI: 10.1007/s10549-012-2256-5.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, MetronomicAdultAgedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, PharmacologicalBlood PlateletsBreast NeoplasmsCombined Modality TherapyCyclophosphamideDrug-Related Side Effects and Adverse ReactionsFemaleGene Expression Regulation, NeoplasticHumansMethotrexateMiddle AgedNeoplasm StagingNeovascularization, PathologicPiperidinesPlatelet Factor 4ProteomicsQuinazolinesVascular Endothelial Growth Factor AVascular Endothelial Growth Factor Receptor-1ConceptsMetastatic breast cancerBreast cancerMetronomic chemotherapyAntiangiogenic therapyCombination antiangiogenic therapyDose-escalation cohortsPrior chemotherapy regimensResponse-evaluable patientsAdvanced breast cancerModest clinical activityDose-limiting toxicityPhase 1 studyPhase 1 trialVascular endothelial growth factorPlatelet factor 4Platelet-associated proteinsEndothelial growth factorEligible patientsLFT abnormalitiesMetronomic cyclophosphamideStable diseaseChemotherapy regimensPrimary endpointSecondary endpointsPartial response
2009
A phase I study of vandetanib and metronomic chemotherapy in advanced breast cancer.
Mayer E, Isakoff S, Hannagan K, Savoie J, Beckman J, Klement G, Gelman R, Winer E, Burstein H. A phase I study of vandetanib and metronomic chemotherapy in advanced breast cancer. Cancer Research 2009, 69: 906. DOI: 10.1158/0008-5472.sabcs-906.Peer-Reviewed Original ResearchAdvanced breast cancerDose-escalation cohortsAbnormal hepatic functionVascular endothelial growth factorBreast cancerMetronomic chemotherapyHepatic functionContinuous low-dose oral cyclophosphamideLow-dose oral cyclophosphamideSequential dose-escalation cohortsStage IV breast cancerOral tyrosine kinase inhibitorGrade 3 eventsOral combination therapyPrior chemotherapy regimensStable brain metastasesModest clinical activityAnti-angiogenic treatmentTyrosine kinase inhibitorsEndothelial growth factorEpidermal growth factor receptorEligible patientsGrowth factor receptorMeasurable diseaseModerate hypertension
2008
VEGF as a Marker for Outcome Among Advanced Breast Cancer Patients Receiving anti-VEGF Therapy with Bevacizumab and Vinorelbine Chemotherapy
Burstein HJ, Chen YH, Parker LM, Savoie J, Younger J, Kuter I, Ryan PD, Garber JE, Chen H, Campos SM, Shulman LN, Harris LN, Gelman R, Winer EP. VEGF as a Marker for Outcome Among Advanced Breast Cancer Patients Receiving anti-VEGF Therapy with Bevacizumab and Vinorelbine Chemotherapy. Clinical Cancer Research 2008, 14: 7871-7877. PMID: 19047116, DOI: 10.1158/1078-0432.ccr-08-0593.Peer-Reviewed Original ResearchConceptsAdvanced breast cancer patientsRefractory breast cancerBreast cancer patientsBreast cancerPlasma VEGFCancer patientsTreatment outcomesSide effectsAnti-vascular endothelial growth factor therapyAdequate end-organ functionEndothelial growth factor therapyImportant new treatment modalityTumor hormone receptor statusMonoclonal anti-VEGF antibodyPrior chemotherapy regimensEnd-organ functionHormone receptor statusAnti-VEGF therapyMetastatic breast cancerGrowth factor therapyNew treatment modalitiesWarrants further evaluationAnti-VEGF antibodyBaseline VEGFEligible patients
2006
Rebeccamycin analog for refractory breast cancer: A randomized phase II trial of dosing schedules
Burstein HJ, Overmoyer B, Gelman R, Silverman P, Savoie J, Clarke K, Dumadag L, Younger J, Ivy P, Winer EP. Rebeccamycin analog for refractory breast cancer: A randomized phase II trial of dosing schedules. Investigational New Drugs 2006, 25: 161-164. PMID: 16969707, DOI: 10.1007/s10637-006-9007-6.Peer-Reviewed Original ResearchConceptsAdvanced breast cancerDifferent treatment schedulesBreast cancerTreatment scheduleAdjuvant chemotherapyArm 2Arm 1Response rateAnthracycline-based adjuvant chemotherapyRefractory advanced breast cancerRandomized phase II trialPrior chemotherapy regimensRefractory breast cancerModest clinical activityPhase II trialPrimary study endpointMetastatic breast cancerCentral venous accessAnemia 5Eligible patientsMeasurable diseaseNausea/Prior chemotherapyStable diseaseChemotherapy regimens
2004
Failure of Higher-Dose Paclitaxel to Improve Outcome in Patients With Metastatic Breast Cancer: Cancer and Leukemia Group B Trial 9342
Winer EP, Berry DA, Woolf S, Duggan D, Kornblith A, Harris LN, Michaelson RA, Kirshner JA, Fleming GF, Perry MC, Graham ML, Sharp SA, Keresztes R, Henderson IC, Hudis C, Muss H, Norton L. Failure of Higher-Dose Paclitaxel to Improve Outcome in Patients With Metastatic Breast Cancer: Cancer and Leukemia Group B Trial 9342. Journal Of Clinical Oncology 2004, 22: 2061-2068. PMID: 15169793, DOI: 10.1200/jco.2004.08.048.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerBreast cancerQuality of lifeOptimal doseResponse rateSignificant dose-response relationshipHigh-dose armPrior chemotherapy regimensHigh-dose therapySymptom assessment questionnaireCycles of treatmentSelf-administered qualitySignificant differencesDose-response relationshipChemotherapy regimensDose therapyHematologic toxicityDose armAssessment QuestionnaireHigh dosesMultivariate analysisSignificant associationInfusionCancerRegimens
1999
Inability to escalate vinorelbine dose intensity using a daily × 3 schedule with and without filgrastim in patients with metastatic breast cancer
Havlin K, Ramirez M, Legler C, Harris L, Matulonis U, Hohneker J, Hayes D, Winer E. Inability to escalate vinorelbine dose intensity using a daily × 3 schedule with and without filgrastim in patients with metastatic breast cancer. Cancer Chemotherapy And Pharmacology 1999, 43: 68-72. PMID: 9923543, DOI: 10.1007/s002800050864.Peer-Reviewed Original ResearchConceptsDana-Farber Cancer InstituteDuke University Medical CenterDose-limiting toxicityGrowth factor supportGrade III neurotoxicityMetastatic breast cancerFebrile neutropeniaBreast cancerFactor supportNonhematologic toxicityStarting doseDose intensityDay 4Stage IV breast cancerMajor dose-limiting toxicityAddition of filgrastimAlternative treatment regimenGrade III stomatitisGrade III vomitingGrade IV mucositisGrade IV thrombocytopeniaGreater nonhematologic toxicityPerformance status 0Prior chemotherapy regimensSemisynthetic vinca alkaloid