| Literature DB >> 33106665 |
Amy Burd1, Ross L Levine2, Brian Druker3, John C Byrd4, Amy S Ruppert5, Alice S Mims5, Uma Borate3, Eytan M Stein2, Prapti Patel6, Maria R Baer7, Wendy Stock8, Michael Deininger9, William Blum10, Gary Schiller11, Rebecca Olin12, Mark Litzow13, James Foran14, Tara L Lin15, Brian Ball2, Michael Boyiadzis16, Elie Traer3, Olatoyosi Odenike8, Martha Arellano10, Alison Walker5, Vu H Duong7, Tibor Kovacsovics9, Robert Collins6, Abigail B Shoben5, Nyla A Heerema5, Matthew C Foster17, Jo-Anne Vergilio18, Tim Brennan18, Christine Vietz18, Eric Severson18, Molly Miller5, Leonard Rosenberg1, Sonja Marcus1, Ashley Yocum1, Timothy Chen5, Mona Stefanos5.
Abstract
Acute myeloid leukemia (AML) is the most common diagnosed leukemia. In older adults, AML confers an adverse outcome1,2. AML originates from a dominant mutation, then acquires collaborative transformative mutations leading to myeloid transformation and clinical/biological heterogeneity. Currently, AML treatment is initiated rapidly, precluding the ability to consider the mutational profile of a patient's leukemia for treatment decisions. Untreated patients with AML ≥ 60 years were prospectively enrolled on the ongoing Beat AML trial (ClinicalTrials.gov NCT03013998 ), which aims to provide cytogenetic and mutational data within 7 days (d) from sample receipt and before treatment selection, followed by treatment assignment to a sub-study based on the dominant clone. A total of 487 patients with suspected AML were enrolled; 395 were eligible. Median age was 72 years (range 60-92 years; 38% ≥75 years); 374 patients (94.7%) had genetic and cytogenetic analysis completed within 7 d and were centrally assigned to a Beat AML sub-study; 224 (56.7%) were enrolled on a Beat AML sub-study. The remaining 171 patients elected standard of care (SOC) (103), investigational therapy (28) or palliative care (40); 9 died before treatment assignment. Demographic, laboratory and molecular characteristics were not significantly different between patients on the Beat AML sub-studies and those receiving SOC (induction with cytarabine + daunorubicin (7 + 3 or equivalent) or hypomethylation agent). Thirty-day mortality was less frequent and overall survival was significantly longer for patients enrolled on the Beat AML sub-studies versus those who elected SOC. A precision medicine therapy strategy in AML is feasible within 7 d, allowing patients and physicians to rapidly incorporate genomic data into treatment decisions without increasing early death or adversely impacting overall survival.Entities:
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Year: 2020 PMID： 33106665 PMCID： PMC8530434 DOI： 10.1038/s41591-020-1089-8
Source DB: PubMed Journal: Nat Med ISSN： 1078-8956 Impact factor: 53.440