2020
Pembrolizumab for management of patients with NSCLC and brain metastases: long-term results and biomarker analysis from a non-randomised, open-label, phase 2 trial
Goldberg SB, Schalper KA, Gettinger SN, Mahajan A, Herbst RS, Chiang AC, Lilenbaum R, Wilson FH, Omay SB, Yu JB, Jilaveanu L, Tran T, Pavlik K, Rowen E, Gerrish H, Komlo A, Gupta R, Wyatt H, Ribeiro M, Kluger Y, Zhou G, Wei W, Chiang VL, Kluger HM. Pembrolizumab for management of patients with NSCLC and brain metastases: long-term results and biomarker analysis from a non-randomised, open-label, phase 2 trial. The Lancet Oncology 2020, 21: 655-663. PMID: 32251621, PMCID: PMC7380514, DOI: 10.1016/s1470-2045(20)30111-x.Peer-Reviewed Original ResearchConceptsBrain metastasis responseYale Cancer CenterPD-L1 expressionPhase 2 trialUntreated brain metastasesBrain metastasesAdrenal insufficiencyAdverse eventsMetastasis responseCNS diseaseCancer CenterCohort 2Cohort 1Eastern Cooperative Oncology Group performance statusTreatment-related serious adverse eventsModified Response Evaluation CriteriaStage IV NSCLCTreatment-related deathsAcute kidney injuryPD-1 blockadeSerious adverse eventsSolid Tumors criteriaPhase 2 studyProportion of patientsResponse Evaluation Criteria
2019
RBTT-07. A PHASE 2 TRIAL OF PEMBROLIZUMAB AND BEVACIZUMAB IN MELANOMA BRAIN MET PATIENTS
Kluger H, Forsyth P, Khushalani N, Eroglu Z, Sznol M, Tran T, Jilaveanu L, Cohen J, Hegde U, Wei W, Mahajan A, Goldberg S, Chiang V, Weiss S. RBTT-07. A PHASE 2 TRIAL OF PEMBROLIZUMAB AND BEVACIZUMAB IN MELANOMA BRAIN MET PATIENTS. Neuro-Oncology 2019, 21: vi220-vi220. PMCID: PMC6847787, DOI: 10.1093/neuonc/noz175.919.Peer-Reviewed Original ResearchVEGF inhibitorsPrimary endpointPD-1/PD-L1Anti-PD-1 activityGrade 3 ALT elevationPre-specified primary endpointPhase 2 studyPhase 2 trialUnconfirmed PRALT elevationDiverticular perforationMetS patientsCerebral edemaPD-L1Wound dehiscencePembroToxicity profileEdemaFurther studiesPromising activityEndpointBRAFmtPembrolizumabMucositisULNResults of a pilot/phase II study of gamma knife radiosurgery for brain metastases and implications for future prospective clinical trials
Yu J, Singh C, Bindra R, Contessa J, Husain Z, Hansen J, Park H, Roberts K, Bond J, Tien C, Guo F, Colaco R, Housri N, Magnuson W, Mahajan A, Omay S, Chiang V. Results of a pilot/phase II study of gamma knife radiosurgery for brain metastases and implications for future prospective clinical trials. Journal Of Radiation Oncology 2019, 8: 39-46. DOI: 10.1007/s13566-018-0370-7.Peer-Reviewed Original ResearchYale-New Haven HospitalPhase II studyBrain metastasesClinical trialsII studyKnife radiosurgeryLocal controlPre-defined primary endpointWhole-brain radiation treatmentFuture prospective clinical trialsEvaluable brain metastasesSymptomatic radiation necrosisMedian patient ageLocal control ratePhase 2 studyGood local controlProspective clinical trialsNumber of metastasesLarge clinical trialsProportional hazards regressionFuture clinical trialsGamma knife radiosurgeryImportant clinical variablesStandard clinical practiceNew Haven Hospital