2022
Surrogacy of Pathologic Complete Response in Trials of Neoadjuvant Therapy for Early Breast Cancer
Conforti F, Pala L, Bagnardi V, De Pas T, Colleoni M, Buyse M, Hortobagyi G, Gianni L, Winer E, Loibl S, Cortes J, Piccart M, Wolff AC, Viale G, Gelber RD. Surrogacy of Pathologic Complete Response in Trials of Neoadjuvant Therapy for Early Breast Cancer. JAMA Oncology 2022, 8: 1668-1675. PMID: 36201176, DOI: 10.1001/jamaoncol.2022.3755.Peer-Reviewed Original ResearchConceptsSurrogate end pointsPathologic complete responseEarly breast cancerBreast cancerEnd pointComplete responseClinical outcomesClinical benefitEvent-free survival dataLong-term patient outcomesReliable surrogate end pointsTrial levelPatient clinical benefitPatients' clinical outcomesAccelerated approval processNeoadjuvant RCTNeoadjuvant therapyPatient survivalClinical trialsDrug regulatory policyEffective therapyPathological responsePatient outcomesPatient levelDrug effects
2018
Drug Resistance in HER2-Positive Breast Cancer Brain Metastases: Blame the Barrier or the Brain?
Kabraji S, Ni J, Lin NU, Xie S, Winer EP, Zhao JJ. Drug Resistance in HER2-Positive Breast Cancer Brain Metastases: Blame the Barrier or the Brain? Clinical Cancer Research 2018, 24: 1795-1804. PMID: 29437794, PMCID: PMC5899637, DOI: 10.1158/1078-0432.ccr-17-3351.Peer-Reviewed Original ResearchMeSH KeywordsAdaptation, PhysiologicalAnimalsAntineoplastic Combined Chemotherapy ProtocolsBlood-Brain BarrierBrain NeoplasmsBreast NeoplasmsClinical Studies as TopicDisease Models, AnimalDrug DevelopmentDrug Evaluation, PreclinicalDrug Resistance, NeoplasmFemaleHumansMiceModels, BiologicalReceptor, ErbB-2Translational Research, BiomedicalTreatment OutcomeXenograft Model Antitumor AssaysConceptsBreast cancer brain metastasesHER2-positive breast cancer brain metastasesTreatment of BCBMHER2-positive breast cancerHER2-targeting drugsInadequate drug penetrationBrain metastasis modelCancer brain metastasesCentral nervous systemClin Cancer ResDrug resistance mechanismsBrain metastasesFirst metastasisEffective therapyCommon siteBreast cancerMetastasis modelPharmacodynamic dataNervous systemTranslational research paradigmDrug penetrationCancer ResDrug sensitivityPatientsDrug development