2022
Clinical Outcomes and Immune Markers by Race in a Phase I/II Clinical Trial of Durvalumab Concomitant with Neoadjuvant Chemotherapy in Early-Stage TNBC.
Foldi J, Kahn A, Silber A, Qing T, Reisenbichler E, Fischbach N, Persico J, Adelson K, Katoch A, Chagpar A, Park T, Blanchard A, Blenman K, Rimm DL, Pusztai L. Clinical Outcomes and Immune Markers by Race in a Phase I/II Clinical Trial of Durvalumab Concomitant with Neoadjuvant Chemotherapy in Early-Stage TNBC. Clinical Cancer Research 2022, 28: 3720-3728. PMID: 35903931, PMCID: PMC9444984, DOI: 10.1158/1078-0432.ccr-22-0862.Peer-Reviewed Original ResearchConceptsImmune-related adverse eventsTriple-negative breast cancerNon-AA patientsEvent-free survivalPhase I/II clinical trialsClinical trialsNeoadjuvant chemotherapyOverall survivalAA patientsEarly-stage triple-negative breast cancerIncidence of irAEsPathologic complete response rateSignificant associationMultivariate logistic regression analysisTumor-infiltrating lymphocyte countsComplete response ratePrimary efficacy endpointPD-L1 statusProportional hazards modelLogistic regression analysisAfrican American womenEFS ratesNeoadjuvant immunotherapyEfficacy endpointAdverse events
2021
Neoadjuvant durvalumab plus weekly nab-paclitaxel and dose-dense doxorubicin/cyclophosphamide in triple-negative breast cancer
Foldi J, Silber A, Reisenbichler E, Singh K, Fischbach N, Persico J, Adelson K, Katoch A, Horowitz N, Lannin D, Chagpar A, Park T, Marczyk M, Frederick C, Burrello T, Ibrahim E, Qing T, Bai Y, Blenman K, Rimm DL, Pusztai L. Neoadjuvant durvalumab plus weekly nab-paclitaxel and dose-dense doxorubicin/cyclophosphamide in triple-negative breast cancer. Npj Breast Cancer 2021, 7: 9. PMID: 33558513, PMCID: PMC7870853, DOI: 10.1038/s41523-021-00219-7.Peer-Reviewed Original ResearchStromal tumor-infiltrating lymphocytesWeekly nab-paclitaxelTriple-negative breast cancerPD-L1Nab-paclitaxelAdverse eventsBreast cancerGrade 3/4 treatment-related adverse eventsPhase I/II trialGrade 3/4 adverse eventsTreatment-related adverse eventsDoxorubicin/cyclophosphamidePhase II studyGuillain-Barre syndromeMononuclear inflammatory cellsPathologic complete responseTumor-infiltrating lymphocytesTumor cell stainingEvaluable patientsNeoadjuvant durvalumabSP263 antibodyII trialNeoadjuvant chemotherapyNeoadjuvant therapyPrimary endpoint
2014
Safety and Effectiveness of Bevacizumab-Containing Treatment for Non–Small-Cell Lung Cancer: Final Results of the ARIES Observational Cohort Study
Lynch TJ, Spigel DR, Brahmer J, Fischbach N, Garst J, Jahanzeb M, Kumar P, Vidaver RM, Wozniak AJ, Fish S, Flick ED, Leon L, Hazard SJ, Kosty MP, Investigators O. Safety and Effectiveness of Bevacizumab-Containing Treatment for Non–Small-Cell Lung Cancer: Final Results of the ARIES Observational Cohort Study. Journal Of Thoracic Oncology 2014, 9: 1332-1339. PMID: 25122429, DOI: 10.1097/jto.0000000000000257.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAngiogenesis InhibitorsAntibodies, Monoclonal, HumanizedAntineoplastic AgentsBevacizumabCarcinoma, Non-Small-Cell LungDisease-Free SurvivalDrug Therapy, CombinationEuropeFemaleFollow-Up StudiesHumansLung NeoplasmsMaleMiddle AgedProspective StudiesSurvival RateTime FactorsTreatment OutcomeUnited StatesVascular Endothelial Growth Factor AConceptsTrial of bevacizumabObservational cohort studyCell lung cancerCohort studyLung cancerARIES observational cohort studyBevacizumab-associated adverse eventsMedian progression-free survivalProspective observational cohort studyReal-world patient populationRecombinant humanized monoclonal antibodyFirst-line bevacizumabProtocol-defined treatmentMedian overall survivalProgression-free survivalEffectiveness of bevacizumabCommunity-based populationHumanized monoclonal antibodyVascular endothelial growth factorEndothelial growth factorSquamous histologyAdvanced NSCLCChemotherapy regimenMetastatic NSCLCAdverse events
2009
Preliminary safety and effectiveness of bevacizumab (BV) based treatment in subpopulations of patients (pts) with non-small cell lung cancer (NSCLC) from the ARIES study: A bevacizumab (BV) treatment observational cohort study (OCS)
Fischbach N, Spigel D, Brahmer J, Garst J, Robles R, Chung C, Wang L, Sing A, Lynch T. Preliminary safety and effectiveness of bevacizumab (BV) based treatment in subpopulations of patients (pts) with non-small cell lung cancer (NSCLC) from the ARIES study: A bevacizumab (BV) treatment observational cohort study (OCS). Journal Of Clinical Oncology 2009, 27: 8040-8040. DOI: 10.1200/jco.2009.27.15_suppl.8040.Peer-Reviewed Original ResearchNon-small cell lung cancerObservational cohort studyAdverse eventsClinical outcomesNSCLC ptsAdvanced non-small cell lung cancerARIES observational cohort studyMedian f/uAnti-VEGF monoclonal antibodyKey safety outcomeProtocol-specified treatmentSafety of bevacizumabCarboplatin/paclitaxelSerious adverse eventsPhase III trialsEffectiveness of bevacizumabCell lung cancerSubpopulation of patientsCohort sizePoor PSBrain metastasesChemotherapy regimenBaseline characteristicsCohort studyIII trials