BACKGROUNDWe evaluated the frequency of genomic testing and treatment patterns by age category in patients with newly diagnosed (ND) acute myeloid leukemia (AML) treated in both academic- and community-based health systems within a single Midwestern State.METHODSRetrospective analysis of data from the Indiana University Health System Enterprise Data Warehouse and two local cancer registries, of 629 patients aged ≥18 years with ND AML during 2011-2018. Primary outcome variables were, proportion of patients with genomic analysis and frequency of mutations. Chemotherapy was categorized as "standard induction" or "other chemotherapy"/targeted therapy, and hypomethylating agents.RESULTSOverall, 13% of ND AML patients between 2011 and 2018 had evidence of a genomic sequencing report with a demonstrated increase to 37% since 2016. Genomic testing was more likely performed in patients: aged ≤60 years than >60 years (45% vs. 30%; p = 0.03), treated in academic versus community hospitals (44% vs. 26%; p = 0.01), and in chemotherapy recipients than non-therapy recipients (46% vs. 19%; p < 0.001). Most common mutations were ASXL1, NPM1, and FLT3. Patients ≥75 years had highest proportion (46%) of multiple (≥3) mutations. Overall, 31.2% of patients with AML did not receive any therapy for their disease. This subgroup was older than chemotherapy recipients (mean age: 71.4 vs. 55.7 years, p < 0.001), and was highest (66.2%) in patients ≥75 years.CONCLUSIONSOur results highlight the unmet medical need to increase access to genomic testing to afford treatment options, particularly to older AML patients in the real-world setting, in this new era of targeted therapies.

13 Jun 2023·Blood Advances

Pevonedistat with azacitidine in older patients with TP53-mutated AML: a phase 2 study with laboratory correlates

Article

Author: Deininger, Michael ; Boyiadzis, Michael M. ; Litzow, Mark R. ; Patel, Prapti A. ; Rosenberg, Leonard ; Saliba, Antoine N. ; Levine, Ross L. ; Peterson, Kevin L. ; Shoben, Abigail B. ; Odenike, Olatoyosi ; Byrd, John C. ; Traer, Elie ; Druker, Brian J. ; Schneider, Paula A. ; Ball, Brian J. ; Chen, Timothy ; Yocum, Ashley O. ; Baer, Maria R. ; Olin, Rebecca L. ; Walker, Alison ; Kaufmann, Scott H. ; Lin, Tara L. ; Blum, William ; Kovacsovics, Tibor ; Gana, Theophilus J. ; Burd, Amy ; Stefanos, Mona ; Martycz, Molly ; Foran, James M. ; Foster, Matthew C. ; Schiller, Gary J. ; Borate, Uma ; Arellano, Martha L. ; Mims, Alice S. ; Heerema, Nyla A. ; Duong, Vu H. ; Stein, Eytan M. ; Stock, Wendy ; Collins, Robert H. ; Marcus, Sonja

Here, we report the results of a phase 2 study of PEVO + AZA in older patients with previously untreated TP53-mutated AML that builds on the previous results.This was a substudy of the Beat AML "umbrella" Master trial evaluating targeted therapies using prospective genomic profiling of previously untreated older patients with AML.The primary objective of this open-label phase 2 study was to evaluate the CCR rate (complete remission [CR] + CR with incomplete hematol. recovery [CRi]) and tolerability of PEVO + AZA combination therapy in patients ≥60 years of age with untreated TP53-mutated AML (variant allele frequency [VAF] ≥30%).This study was approved by a central institutional review board and by local institutional review boards and was conducted according to the Declaration of Helsinki.In summary, in this phase 2 Beat AML substudy, treatment with AZA + PEVO did not induce responses (CCR) in older patients with TP53-mutated AML.These observations mirror recent results with the same combination in myelodysplatic syndrome, stand in contrast to previous results in AML, and do not support the combination as targeted therapy in TP53-mutated AML.Reports of studies (#NCT04172844 and #NCT03862157) examining the addition of venetoclax to AZA + PEVO in AML are eagerly awaited.

15 Nov 2022·Blood

Entospletinib (ENTO) in Combination with Cytarabine (Ara-C) and Daunorubicin (DNR) in Newly Diagnosed (ND) Adult Patients with NPM1-Mutated and FLT3-ITD Wild-Type Acute Myeloid Leukemia (AML) Is Associated with Good Response and Survival: A Phase 2 Sub-Study of the Beat AML Master Trial

Author: Foster, Matthew C. ; Rosenberg, Leonard ; Stein, Eytan ; Gana, Theophilus J ; Borate, Uma ; Blum, William G. ; Druker, Brian J. ; Heerema, Nyla A. ; Duong, Vu H. ; Arellano, Martha L. ; Levine, Ross L. ; Smith, Catherine ; Li, Rui ; Olin, Rebecca L. ; Stock, Wendy ; Martycz, Molly ; Byrd, John C. ; Curran, Emily K ; Traer, Elie ; Huang, Ying ; Yocum, Ashley O. ; Mims, Alice S. ; Foran, James M. ; Swords, Ronan T. ; Boyiadzis, Michael M. ; Odenike, Olatoyosi ; Druggan, Franchesca ; Redner, Robert L. ; Collins, Robert H. ; Stefanos, Mona ; Patel, Prapti ; Madanat, Yazan F. ; Baer, Maria R. ; Al-Mansour, Zeina ; Deininger, Michael W. ; Marcus, Sonja ; Burd, Amy ; Chen, Timothy ; Schiller, Gary J. ; Lin, Tara L. ; Kovacsovics, Tibor

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