Acute Myeloid Leukemia, Version 3.2019, NCCN Clinical Practice Guidelines in Oncology

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Abstract

Acute myeloid leukemia (AML) is the most common form of acute leukemia among adults and accounts for the largest number of annual deaths due to leukemias in the United States. Recent advances have resulted in an expansion of treatment options for AML, especially concerning targeted therapies and low-intensity regimens. This portion of the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for AML focuses on the management of AML and provides recommendations on the workup, diagnostic evaluation and treatment options for younger (age <60 years) and older (age ≥60 years) adult patients.

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Most cited references 75

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Efficacy of azacitidine compared with that of conventional care regimens in the treatment of higher-risk myelodysplastic syndromes: a randomised, open-label, phase III study.

Pierre Fenaux, Ghulam J Mufti, Eva Hellstrom-Lindberg … (2009)

Drug treatments for patients with high-risk myelodysplastic syndromes provide no survival advantage. In this trial, we aimed to assess the effect of azacitidine on overall survival compared with the three commonest conventional care regimens. In a phase III, international, multicentre, controlled, parallel-group, open-label trial, patients with higher-risk myelodysplastic syndromes were randomly assigned one-to-one to receive azacitidine (75 mg/m(2) per day for 7 days every 28 days) or conventional care (best supportive care, low-dose cytarabine, or intensive chemotherapy as selected by investigators before randomisation). Patients were stratified by French-American-British and international prognostic scoring system classifications; randomisation was done with a block size of four. The primary endpoint was overall survival. Efficacy analyses were by intention to treat for all patients assigned to receive treatment. This study is registered with ClinicalTrials.gov, number NCT00071799. Between Feb 13, 2004, and Aug 7, 2006, 358 patients were randomly assigned to receive azacitidine (n=179) or conventional care regimens (n=179). Four patients in the azacitidine and 14 in the conventional care groups received no study drugs but were included in the intention-to-treat efficacy analysis. After a median follow-up of 21.1 months (IQR 15.1-26.9), median overall survival was 24.5 months (9.9-not reached) for the azacitidine group versus 15.0 months (5.6-24.1) for the conventional care group (hazard ratio 0.58; 95% CI 0.43-0.77; stratified log-rank p=0.0001). At last follow-up, 82 patients in the azacitidine group had died compared with 113 in the conventional care group. At 2 years, on the basis of Kaplan-Meier estimates, 50.8% (95% CI 42.1-58.8) of patients in the azacitidine group were alive compared with 26.2% (18.7-34.3) in the conventional care group (p<0.0001). Peripheral cytopenias were the most common grade 3-4 adverse events for all treatments. Treatment with azacitidine increases overall survival in patients with higher-risk myelodysplastic syndromes relative to conventional care.

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Safety and preliminary efficacy of venetoclax with decitabine or azacitidine in elderly patients with previously untreated acute myeloid leukaemia: a non-randomised, open-label, phase 1b study.

Michael J Thirman, Martha Arellano, Mark Frattini … (2018)

Elderly patients (aged ≥65 years) with acute myeloid leukaemia have poor outcomes and no effective standard-of-care therapy exists. Treatment with hypomethylating agents such as azacitidine and decitabine is common, but responses are modest and typically short-lived. The oral anti-apoptotic B-cell lymphoma 2 protein inhibitor, venetoclax, has shown promising single-agent activity in patients with relapsed or refractory acute myeloid leukaemia and preclinical data suggested synergy between hypomethylating agents and venetoclax, which led to this combination phase 1b study.

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Azacitidine prolongs overall survival compared with conventional care regimens in elderly patients with low bone marrow blast count acute myeloid leukemia.

Pierre Fenaux, Ghulam J Mufti, Eva Hellstrom-Lindberg … (2010)

In a phase III randomized trial, azacitidine significantly prolonged overall survival (OS) compared with conventional care regimens (CCRs) in patients with intermediate-2- and high-risk myelodysplastic syndromes. Approximately one third of these patients were classified as having acute myeloid leukemia (AML) under current WHO criteria. This analysis compared the effects of azacitidine versus CCR on OS in this subgroup. Patients were randomly assigned to receive subcutaneous azacitidine 75 mg/m(2)/d or CCR (best supportive care [BSC] only, low-dose cytarabine (LDAC), or intensive chemotherapy [IC]). Of the 113 elderly patients (median age, 70 years) randomly assigned to receive azacitidine (n = 55) or CCR (n = 58; 47% BSC, 34% LDAC, 19% IC), 86% were considered unfit for IC. At a median follow-up of 20.1 months, median OS for azacitidine-treated patients was 24.5 months compared with 16.0 months for CCR-treated patients (hazard ratio = 0.47; 95% CI, 0.28 to 0.79; P = .005), and 2-year OS rates were 50% and 16%, respectively (P = .001). Two-year OS rates were higher with azacitidine versus CCR in patients considered unfit for IC (P = .0003). Azacitidine was associated with fewer total days in hospital (P < .0001) than CCR. In older adult patients with low marrow blast count (20% to 30%) WHO-defined AML, azacitidine significantly prolongs OS and significantly improves several patient morbidity measures compared with CCR.

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Author and article information

Journal

Title: Journal of the National Comprehensive Cancer Network

Publisher: Harborside Press, LLC

ISSN (Print): 1540-1405

ISSN (Electronic): 1540-1413

Publication date Created: June 2019

Publication date (Print): June 2019

Volume: 17

Issue: 6

Pages: 721-749

Affiliations

[1 ]1Memorial Sloan Kettering Cancer Center;

[2 ]2Roswell Park Comprehensive Cancer Center;

[3 ]3Robert H. Lurie Comprehensive Cancer Center of Northwestern University;

[4 ]4Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance;

[5 ]5Fred & Pamela Buffett Cancer Center;

[6 ]6University of Michigan Rogel Cancer Center;

[7 ]7Stanford Cancer Institute;

[8 ]8Case Comprehensive Cancer Center/University Hospitals Seidman Cancer Center and Cleveland Clinic Taussig Cancer Institute;

[9 ]9Massachusetts General Hospital Cancer Center;

[10 ]10UC San Diego Moores Cancer Center;

[11 ]11Mayo Clinic Cancer Center;

[12 ]12University of Wisconsin Carbone Cancer Center;

[13 ]13Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine;

[14 ]14Moffitt Cancer Center;

[15 ]15Duke Cancer Institute;

[16 ]16City of Hope National Medical Center;

[17 ]17St. Jude Children’s Research Hospital/The University of Tennessee Health Science Center;

[18 ]18The Ohio State University Comprehensive Cancer Center - James Cancer Hospital and Solove Research Institute;

[19 ]19UCSF Helen Diller Family Comprehensive Cancer Center;

[20 ]20O’Neal Comprehensive Cancer Center at UAB;

[21 ]21Abramson Cancer Center at the University of Pennsylvania;

[22 ]22University of Colorado Cancer Center;

[23 ]23The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins;

[24 ]24Yale Cancer Center/Smilow Cancer Hospital;

[25 ]25The University of Texas MD Anderson Cancer Center;

[26 ]26Huntsman Cancer Institute at the University of Utah;

[27 ]27Dana-Farber/Brigham and Women’s Cancer Center;

[28 ]28Vanderbilt-Ingram Cancer Center; and

[29 ]29National Comprehensive Cancer Network

Article

DOI: 10.6004/jnccn.2019.0028

PubMed ID: 31200351

SO-VID: 15de6a3d-4ecc-4d40-8a4e-397c63cbfc57

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Most cited references 75

Efficacy of azacitidine compared with that of conventional care regimens in the treatment of higher-risk myelodysplastic syndromes: a randomised, open-label, phase III study.

Safety and preliminary efficacy of venetoclax with decitabine or azacitidine in elderly patients with previously untreated acute myeloid leukaemia: a non-randomised, open-label, phase 1b study.

Azacitidine prolongs overall survival compared with conventional care regimens in elderly patients with low bone marrow blast count acute myeloid leukemia.

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Cited by 180