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
2011
OT3-01-03: Pre-Surgical Evaluation of the AKT Inhibitor MK-2206 in Patients with Operable Invasive Breast Cancer: New York Cancer Consortium Trial P8740.
Kalinsky K, Sparano J, Kim M, Crew K, Maurer M, Taback B, Feldman S, Hibshoosh H, Wiechmann L, Adelson K, Hershman D. OT3-01-03: Pre-Surgical Evaluation of the AKT Inhibitor MK-2206 in Patients with Operable Invasive Breast Cancer: New York Cancer Consortium Trial P8740. Cancer Research 2011, 71: ot3-01-03-ot3-01-03. DOI: 10.1158/0008-5472.sabcs11-ot3-01-03.Peer-Reviewed Original ResearchPre-surgical studyInvasive breast cancerBreast cancerPI3K/AktWeekly MKPost-treatment tissue samplesOperable invasive breast cancerPeripheral blood mononuclear cellsEarly phase clinical studiesDownstream PI3K/Akt pathwayClinical stage IClinical trial programBlood mononuclear cellsMain eligibility criteriaPre-surgical evaluationEarly clinical testingPI3K/Akt pathwayEffects of MKAKT inhibitor MKPost-treatment samplesAnti-cancer propertiesParaffin-embedded tissuesAccrue patientsAnti-cancer agentsNeoadjuvant chemotherapy