2020
Tumor Mutational Burden and PTEN Alterations as Molecular Correlates of Response to PD-1/L1 Blockade in Metastatic Triple-Negative Breast Cancer
Barroso-Sousa R, Keenan TE, Pernas S, Exman P, Jain E, Garrido-Castro AC, Hughes M, Bychkovsky B, Umeton R, Files JL, Lindeman NI, MacConaill LE, Hodi FS, Krop IE, Dillon D, Winer EP, Wagle N, Lin NU, Mittendorf EA, Van Allen EM, Tolaney SM. Tumor Mutational Burden and PTEN Alterations as Molecular Correlates of Response to PD-1/L1 Blockade in Metastatic Triple-Negative Breast Cancer. Clinical Cancer Research 2020, 26: 2565-2572. PMID: 32019858, PMCID: PMC7269810, DOI: 10.1158/1078-0432.ccr-19-3507.Peer-Reviewed Original ResearchConceptsMetastatic triple-negative breast cancerHigh tumor mutational burdenProgression-free survivalTumor mutational burdenObjective response rateImmune checkpoint inhibitorsAnti-PD-1/L1 therapyTriple-negative breast cancerOverall survivalL1 therapyPD-L1Breast cancerMutational burdenLow objective response rateLonger progression-free survivalShorter progression-free survivalDana-Farber Cancer InstituteTumor genomic featuresShorter overall survivalMutations/megabaseCheckpoint inhibitorsVisceral metastasesL1 blockadePerformance statusPrior lines
2012
SU2C phase Ib study of pan-PI3K inhibitor BKM120 with letrozole in ER+/HER2- metastatic breast cancer (MBC).
Mayer I, Abramson V, Balko J, Isakoff S, Kuba M, Sanders M, Forero-Torres A, Yap J, Van Den Abbeele A, Li Y, Arteaga C, Winer E. SU2C phase Ib study of pan-PI3K inhibitor BKM120 with letrozole in ER+/HER2- metastatic breast cancer (MBC). Journal Of Clinical Oncology 2012, 30: 510-510. DOI: 10.1200/jco.2012.30.15_suppl.510.Peer-Reviewed Original ResearchMetastatic breast cancerPan-PI3K inhibitor BKM120FDG-PETArm API3K pathway alterationsPhase Ib studyPhase Ib trialPost-menopausal patientsPI3K pathway inhibitionPI3K mutationsPI3K inhibitorsIb trialStable diseaseVisceral metastasesUnacceptable toxicityMost patientsArm BMedian ageDisease progressionPharmacodynamic biomarkersBreast cancerTreatment responseTumor biopsiesAntiestrogen resistanceIb study
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 guidelinesTolerability and efficacy of 500 mg fulvestrant in postmenopausal women with estrogen receptor (ER)+ advanced breast cancer
Come S, Parker L, Wulf G, Kuter I, Ryan P, Tkaczuk K, Borges V, Kasper H, Gelman R, Winer E. Tolerability and efficacy of 500 mg fulvestrant in postmenopausal women with estrogen receptor (ER)+ advanced breast cancer. Journal Of Clinical Oncology 2009, 27: 1050-1050. DOI: 10.1200/jco.2009.27.15_suppl.1050.Peer-Reviewed Original ResearchClinical benefit rateStable diseasePartial responseComplete responseEstrogen receptorEndocrine therapyMedian timeBreast cancerEvaluable metastatic breast cancerFirst-line metastatic settingInjection site discomfortAdjuvant endocrine therapyAdjuvant endocrine treatmentPhase II studyTreatment-related toxicityMetastatic breast cancerAdvanced diseaseEndocrine treatmentMetastatic settingPostmenopausal patientsPrimary endpointRECIST criteriaVisceral metastasesII studyPostmenopausal womenA Comparative Study of Exemestane Versus Anastrozole in Patients with Postmenopausal Breast Cancer with Visceral Metastases
Campos SM, Guastalla JP, Subar M, Abreu P, Winer EP, Cameron DA. A Comparative Study of Exemestane Versus Anastrozole in Patients with Postmenopausal Breast Cancer with Visceral Metastases. Clinical Breast Cancer 2009, 9: 39-44. PMID: 19299239, DOI: 10.3816/cbc.2009.n.007.Peer-Reviewed Original ResearchConceptsPostmenopausal breast cancerBreast cancer metastasisBreast cancerPostmenopausal patientsVisceral metastasesAdverse eventsObjective responseVisceral sitesVisceral lesionsClinical benefitTreatment-related adverse eventsCancer metastasisAromatase inhibitor studiesAdvanced breast cancerResponse Evaluation CriteriaExemestane groupEndocrine therapyPostmenopausal womenPrimary endpointSecondary endpointsMedian survivalOverall survivalSuch patientsTreat analysisStudy closure