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. 2020 Jun 30;1(1):58-68.
doi: 10.1002/jha2.16. eCollection 2020 Jul.

Diagnostic and molecular testing patterns in patients with newly diagnosed acute myeloid leukemia in the Connect® MDS/AML Disease Registry

Daniel A Pollyea  1 , Tracy I George  2 , Mehrdad Abedi  3 , Rafael Bejar  4 , Christopher R Cogle  5 , Kathryn Foucar  6 , Guillermo Garcia-Manero  7 , David L Grinblatt  8 , Rami S Komrokji  9 , Jaroslaw P Maciejewski  10 , Dennis A Revicki  11 , Gail J Roboz  12 , Michael R Savona  13 , Bart L Scott  14 , Mikkael A Sekeres  10 , Michael A Thompson  15 , Sandra E Kurtin  16 , Chrystal U Louis  17 , Melissa Nifenecker  17 , E Dawn Flick  18 , Arlene S Swern  17 , Pavel Kiselev  17 , David P Steensma  19 , Harry P Erba  20
Affiliations

Diagnostic and molecular testing patterns in patients with newly diagnosed acute myeloid leukemia in the Connect® MDS/AML Disease Registry

Daniel A Pollyea et al. EJHaem. .

Abstract

Diagnostic and molecular genetic testing are key in advancing the treatment of acute myeloid leukemia (AML), yet little is known about testing patterns outside of clinical trials, especially in older patients. We analyzed diagnostic and molecular testing patterns over time in 565 patients aged ≥ 55 years with newly diagnosed AML enrolled in the Connect® MDS/AML Disease Registry (NCT01688011) in the United States. Diagnostic data were recorded at enrolment and compared with published guidelines. The percentage of bone marrow blasts was reported for 82.1% of patients, and cellularity was the most commonly reported bone marrow morphological feature. Flow cytometry, karyotyping, molecular testing, and fluorescence in situ hybridization were performed in 98.8%, 95.4%, 75.9%, and 75.7% of patients, respectively. Molecular testing was done more frequently at academic than community/government sites (84.3% vs 70.2%; P < .001). Enrolment to the Registry after 2016 was significantly associated with molecular testing at academic sites (odds ratio [OR] 2.59; P = .023) and at community/government sites (OR 4.85; P < .001) in logistic regression analyses. Better understanding of practice patterns may identify unmet needs and inform institutional protocols regarding the diagnosis of patients with AML.

Keywords: acute myeloid leukemia; diagnostic testing; leukemia diagnosis; leukemia therapy; molecular testing; registry.

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Conflict of interest statement

DAP: AbbVie, Bristol‐Myers Squibb, Daiichi Sankyo – advisory board member and consultancy; Agios, Forty Seven, Pfizer – advisory board member; Takeda – consultancy; Glycomimetics – data safety and monitoring committee. TIG: Bristol‐Myers Squibb – consultancy; MA: Bristol‐Myers Squibb – advisory board, AbbVie, Bristol‐Myers Squibb, Gilead, Seattle Genetrix, Takeda – speaker panel; CRC, JPM, GGM: no conflicts to disclose; RB: AbbVie, Astex Daiichi Sankyo, Forty Seven, NeoGenomics – consultancy; Bristol‐Myers Squibb – consultancy, honoraria, research funding; Xian‐Janssen – honoraria; KF: Bristol‐Myers Squibb – advisory board member. DLG: AbbVie – consultancy; Alexion – speakers bureau; Astellas, Bristol‐Myers Squibb – advisory board member. RSK: Alexion, Jazz Pharmaceuticals, Novartis – speakers bureau; Agios, Bristol‐Myers Squibb, Daiichi Sankyo, Inc., Incyte, Janssen, Pfizer – consultancy. DAR: Allergan, Amgen, Bristol‐Myers Squibb, Takeda – research funding and consultancy. GJR: AbbVie, Actinum, Agios, Amphivena, Argenx, Astex, Astellas, Bayer, Bristol‐Myers Squibb, Celltrion, Daiichi Sankyo, Eisai, Janssen, Jazz Pharmaceuticals, Novartis, MEI Pharma, Orsenix, Otsuka, Pfizer, Roche/Genentech, Sandoz, Takeda, Trovgene – consultancy, advisory board or data and safety monitoring committee; Cellectis – research funding. MRS: AbbVie – advisory board member, consulting; Boehringer Ingelheim – patents and royalties; Bristol‐Myers Squibb, Selvita – advisory board member; Incyte – advisory board member, research funding; Karyopharm – advisory board member, consultancy, equity ownership; Sunesis – research funding; Takeda, TG Therapeutics – advisory board member, research funding. BLS: Agios – speakers bureau; Alexion, Bristol‐Myers Squibb – advisory board member, consultancy, speakers bureau; Incyte – advisory board member, speakers bureau; Novartis – research funding. MAS: Bristol‐Myers Squibb, Pfizer, Takeda/Millenium – consulting. MAT: Adaptive, Bristol‐Myers Squibb, Doximity, GlaxoSmithKline, Strata Oncology, Syapse Precision Medicine Council, VIA Oncology, UpToDate – consultancy; Doximity – equity; AbbVie, Bristol Myers‐Squibb, CRAB CTC, Denovo, Hoosier Research Network, Lilly, LynxBio, Stata Oncology, Takeda, TG Therapeutics – institutional research funding; SEK: Agios and Bristol‐Myers Squibb – consultancy. CUL, MN, ASS, PK: Bristol‐Myers Squibb ‐ equity and employment. EDF: Bristol‐Myers Squibb – employment. DPS: Astex, Bristol‐Myers Squibb, Onconova, Pfizer, StemLine, Summer Road, Takeda – consultancy. HPE: Agios, Bristol‐Myers Squibb, Jazz Pharmaceuticals, Incyte, Novartis – speakers bureau; AbbVie, Agios, Amgen, Astellas, Bristol‐Myers Squibb, Daiichi Sankyo, Glycomimetics, ImmunoGen, Incyte, Jazz, MacroGenics, Novartis, Pfizer, Seattle Genetics – consultancy; AbbVie, Daiichi Sankyo, ImmunoGen, Macrogenics – research funding; Glycomimetics – data safety and monitoring committee; Covance – independent review committee.

Figures

FIGURE 1
FIGURE 1
Bone marrow blast assessment. "Other" refers to estimates of bone marrow blast percentage made from aspirate smear or biopsy sections. AML, acute myeloid leukemia
FIGURE 2
FIGURE 2
Differences in molecular genetic testing rates in Registry patients with newly diagnosed AML. (A) Proportion of patients with AML who received molecular testing, and most frequently tested genes from the 19 that are included in the study electronic database. (B) Factors significantly associated with molecular testing at academic and community/government sites, as determined by multivariable testing. Other refers to South, Midwestern and West US regions. AML, acute myeloid leukaemia; ELN, European Leukemia Network
FIGURE 3
FIGURE 3
Frequency of ASH/CAP guideline‐recommended tests among patients who received any molecular genetic testing (n = 429). Recommendation #16 of the ASH/CAP guidelines recommends that all patients with AML should be tested for FLT3. As per recommendation #17, those with CBF‐AML should also be assessed for KIT mutations. Recommendation #19 notes that patients who do not have CBF‐AML, APL, or AML associated with MDCA should undergo mutational analysis for NPM1, CEBPA, and RUNX1. Text listed in red refers to the proportion of patients who received testing that is strongly recommended in the ASH/CAP guidelines, while white text refers to the proportion of patients who received testing that is recommended. AML, acute myeloid leukaemia; ASH/CAP, American Society of Hematology/College of American Pathologists; CBF‐AML, core binding factor AML with t(8;21)/AML with inv(16) or t(16;16); MDCA, myelodysplastic cytogenetic abnormalities
FIGURE 4
FIGURE 4
Frequency of testing for specific gene mutations over time. Values represent the proportion of patients tested for gene mutations who were tested for that specific mutation.
See this image and copyright information in PMC

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