2023
A multicenter phase Ib trial of the histone deacetylase inhibitor entinostat in combination with pembrolizumab in patients with myelodysplastic syndromes/neoplasms or acute myeloid leukemia refractory to hypomethylating agents
Bewersdorf J, Shallis R, Sharon E, Park S, Ramaswamy R, Roe C, Irish J, Caldwell A, Wei W, Yacoub A, Madanat Y, Zeidner J, Altman J, Odenike O, Yerrabothala S, Kovacsovics T, Podoltsev N, Halene S, Little R, Piekarz R, Gore S, Kim T, Zeidan A. A multicenter phase Ib trial of the histone deacetylase inhibitor entinostat in combination with pembrolizumab in patients with myelodysplastic syndromes/neoplasms or acute myeloid leukemia refractory to hypomethylating agents. Annals Of Hematology 2023, 103: 105-116. PMID: 38036712, DOI: 10.1007/s00277-023-05552-4.Peer-Reviewed Original ResearchConceptsDose-limiting toxicityAcute myeloid leukemiaMarrow complete remissionPhase Ib trialAdverse eventsIb trialDose escalationNCI Cancer Therapy Evaluation ProgramAcute myeloid leukemia refractoryHematologic adverse eventsProtocol-defined responseDose level 1Anti-PD1 therapyAnti-PD1 antibodyDose-escalation designLimited clinical efficacySystems immunology approachHistone deacetylase inhibitor entinostatLeukemia refractoryMCR patientsComplete remissionRespiratory failureSuppressor cellsEscalation designClinical efficacy
2020
Management of hyperleukocytosis and impact of leukapheresis among patients with acute myeloid leukemia (AML) on short- and long-term clinical outcomes: a large, retrospective, multicenter, international study
Stahl M, Shallis RM, Wei W, Montesinos P, Lengline E, Neukirchen J, Bhatt VR, Sekeres MA, Fathi AT, Konig H, Luger S, Khan I, Roboz GJ, Cluzeau T, Martínez-Cuadron D, Raffoux E, Germing U, Umakanthan JM, Mukherjee S, Brunner AM, Miller A, McMahon CM, Ritchie EK, Rodríguez-Veiga R, Itzykson R, Boluda B, Rabian F, Tormo M, Acuña-Cruz E, Rabinovich E, Yoo B, Cano I, Podoltsev NA, Bewersdorf JP, Gore S, Zeidan AM. Management of hyperleukocytosis and impact of leukapheresis among patients with acute myeloid leukemia (AML) on short- and long-term clinical outcomes: a large, retrospective, multicenter, international study. Leukemia 2020, 34: 3149-3160. PMID: 32132655, PMCID: PMC8155811, DOI: 10.1038/s41375-020-0783-3.Peer-Reviewed Original ResearchConceptsAcute myeloid leukemiaOverall survivalMyeloid leukemiaMultivariate analysisLong-term clinical outcomesComposite complete remissionImpact of leukapheresisManagement of hyperleukocytosisMedian overall survivalThirty-day mortalityHigh-quality evidenceWhite cell countProportional hazards modelUse of leukapheresisLogistic regression modelsSignificant resource useIntensive chemotherapyComplete remissionHazard ratioClinical outcomesInferior outcomesUnadjusted analysesQuality evidencePotential complicationsOdds ratio