Real-world experience with decitabine as a first-line treatment in 306 elderly acute myeloid leukaemia patients unfit for intensive chemotherapy.
Aged
Aged, 80 and over
Antimetabolites, Antineoplastic
/ adverse effects
Cause of Death
Decitabine
/ adverse effects
Disease Progression
Female
Humans
Infections
/ etiology
Kaplan-Meier Estimate
Leukemia, Myeloid, Acute
/ drug therapy
Male
Multicenter Studies as Topic
/ statistics & numerical data
Observational Studies as Topic
/ statistics & numerical data
Prognosis
Proportional Hazards Models
Risk Factors
Treatment Outcome
acute myeloid leukaemia
decitabine
first-line therapy
unfit patients
Journal
Hematological oncology
ISSN: 1099-1069
Titre abrégé: Hematol Oncol
Pays: England
ID NLM: 8307268
Informations de publication
Date de publication:
Oct 2019
Oct 2019
Historique:
received:
25
06
2019
revised:
30
07
2019
accepted:
31
07
2019
pubmed:
7
8
2019
medline:
20
11
2019
entrez:
7
8
2019
Statut:
ppublish
Résumé
Despite widespread use of decitabine to treat acute myeloid leukaemia (AML), data on its effectiveness and safety in the real-world setting are scanty. Thus, to analyze the performance of decitabine in clinical practice, we pooled together patient-level data of three multicentric observational studies conducted since 2013 throughout Italy, including 306 elderly AML patients (median age 75 years), unfit for intensive chemotherapy, treated with first-line decitabine therapy at the registered schedule of 20 mg/m
Substances chimiques
Antimetabolites, Antineoplastic
0
Decitabine
776B62CQ27
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
447-455Informations de copyright
© 2019 John Wiley & Sons, Ltd.
Références
Rodriguez-Abreu D, Bordoni A, Zucca E. Epidemiology of hematological malignancies. Ann Oncol. 2007;18(suppl1):i3-i8.
Sant M, Allemani C, Tereanu C, et al. Incidence of hematologic malignancies in Europe by morphological subtype: results of the HAEMACARE project. Blood. 2010;116(19):3724-3734.
Noone A, Howlader N, Krapcho M, et al. National Cancer Institute. Bethesda. SEER Cancer Statistics Review 2018-Acute Myeloid Leukemia Section 1975-2015.
Döhner H, Estey E, Grimwade D, et al. Diagnosis and management of AML in adults: 2017 ELN recommendations from an international expert panel. Blood. 2017;129(4):424-447.
Lowenberg B, Downing JR, Burnett A. Acute myeloid leukemia. N Engl J Med. 1999;341(14):1051-1062.
Curran MP. Decitabine: a review of its use in older patients with acute myeloid leukaemia. Drugs Aging. 2013;30(6):447-458.
Montalban-Bravo G, Garcia-Manero G. Novel drugs for older patients with acute myeloid leukemia. Leukemia. 2015;29(4):760-769.
Kantarjian HM, Thomas XG, Dmoszynska A, et al. Multicenter, randomized, open-label, phase III trial of decitabine versus patient choice, with physician advice, of either supportive care or low-dose cytarabine for the treatment of older patients with newly diagnosed acute myeloid leukemia. J Clin Oncol. 2012;30(21):2670-2677.
Cashen AF, Schiller GJ, O'Donnell MR, DiPersio JF. Multicenter, phase II study of decitabine for the first-line treatment of older patients with acute myeloid leukemia. J Clin Oncol. 2009;28(4):556-561.
Juliusson G, Lazarevic V, Hörstedt A-S, Hagberg O, Höglund M. Acute myeloid leukemia in the real world: why population-based registries are needed. Blood. 2012;119(17):3890-3899.
Nordon C, Karcher H, Groenwold RH, et al. The “efficacy-effectiveness gap”: historical background and current conceptualization. Value Health. 2016;19(1):75-81.
Aprile L, Sammartano V, Alunni G, et al. Italian real-life experience of decitabine in elderly acute myeloid leukemia patients: interim analysis of multicentric observational DEA65 study. Haematologica. 2017;102(s3). Abstract 389
Borlenghi E, Filì C, Basilico C, et al. Efficacy and safety of decitabine as first-line therapy for elderly patients with acute myeloid leukemia. A real life multicentric experience of the northern Italy. Blood. 2017;130. Abstract 1315
Filì C, Candoni A, Imbergamo A, et al. Decitabine in patients with newly diagnosed and relapsed acute myeloid leukemia: the real-life experience from the “Italian Triveneto Registry”. Haematologica. 2017;102(s3). Abstract 8-9
Borlenghi E, Cattaneo C, Bernardi M, et al. Efficacy and safety of decitabine in elderly AML patients: a real-life multicenter experience of the network Rete Ematologica Lombarda. Haematologica. 2017;102(s3). Abstract 676-677
Park H, Chung H, Lee J, et al. Decitabine as a first-line treatment for older adults newly diagnosed with acute myeloid leukemia. Yonsei Med J. 2017;58(1):35-42.
Yi JH, Park S, Kim JH, et al. A multicenter, retrospective analysis of elderly patients with acute myeloid leukemia who were treated with decitabine. Oncotarget. 2018;9(5):6607-6614.
Ferrara F, Barosi G, Venditti A, et al. Consensus-based definition of unfitness to intensive and non-intensive chemotherapy in acute myeloid leukemia: a project of SIE, SIES and GITMO group on a new tool for therapy decision making. Leukemia. 2013;27(5):997-999.
Schemper M, Smith TL. A note on quantifying follow-up in studies of failure time. Contemp Clin Trials. 1996;17(4):343-346.
Grimwade D, Hills RK, Moorman AV, et al. National Cancer Research Institute Adult Leukaemia Working G. Refinement of cytogenetic classification in acute myeloid leukemia: determination of prognostic significance of rare recurring chromosomal abnormalities among 5876 younger adult patients treated in the United Kingdom Medical Research Council trials. Blood. 2010;116(3):354-365.
Savona MR, Malcovati L, Komrokji R, et al. An international consortium proposal of uniform response criteria for myelodysplastic/myeloproliferative neoplasms (MDS/MPN) in adults. Blood. 2015;125(12):1857-1865.
Lübbert M, Rüter BH, Claus R, et al. A multicenter phase II trial of decitabine as first-line treatment for older patients with acute myeloid leukemia judged unfit for induction chemotherapy. Haematologica. 2012;97(3):393-401.
Dechartres A, Chevret S, Lambert J, Calvo F, Levy V. Inclusion of patients with acute leukemia in clinical trials: a prospective multicenter survey of 1066 cases. Ann Oncol. 2010;22(1):224-233.
Tsimberidou AM, Estey E. Relevance of clinical trials in acute myeloid leukaemia. Hematol Oncol. 2008;26(3):182-183.
Prebet T, Sun Z, Figueroa ME, et al. Prolonged administration of azacitidine with or without entinostat for myelodysplastic syndrome and acute myeloid leukemia with myelodysplasia-related changes: results of the US Leukemia Intergroup trial E1905. J Clin Oncol. 2014;32(12):1242-1248.
Falantes J, Pleyer L, Thépot S, et al. Real life experience with frontline azacitidine in a large series of older adults with acute myeloid leukemia stratified by MRC/LRF score: results from the expanded international E-ALMA series (E-ALMA+). Leuk Lymphoma. 2018;59(5):1113-1120.
Thepot S, Itzykson R, Seegers V, et al. Azacitidine in untreated acute myeloid leukemia: a report on 149 patients. Am J Hematol. 2014;89(4):410-416.
Gupta N, Miller A, Gandhi S, et al. Comparison of epigenetic versus standard induction chemotherapy for newly diagnosed acute myeloid leukemia patients≥ 60 years old. Am J Hematol. 2015;90(7):639-646.
Ritchie EK, Feldman EJ, Christos PJ, et al. Decitabine in patients with newly diagnosed and relapsed acute myeloid leukemia. Leuk Lymphoma. 2013;54(9):2003-2007.
Döhner H, Estey EH, Amadori S, et al. Diagnosis and management of acute myeloid leukemia in adults: recommendations from an international expert panel, on behalf of the European LeukemiaNet. Blood. 2010;115(3):453-474.
Boddu PC, Kantarjian HM, Ravandi F, et al. Characteristics and outcomes of older patients with secondary acute myeloid leukemia according to treatment approach. Cancer. 2017;123(16):3050-3060.
Quintás-Cardama A, Ravandi F, Liu-Dumlao T, et al. Epigenetic therapy is associated with similar survival compared with intensive chemotherapy in older patients with newly diagnosed acute myeloid leukemia. Blood. 2012;120(24):4840-4845.
Leith CP, Kopecky KJ, Godwin J, et al. Acute myeloid leukemia in the elderly: assessment of multidrug resistance (MDR1) and cytogenetics distinguishes biologic subgroups with remarkably distinct responses to standard chemotherapy. A Southwest Oncology Group study. Blood. 1997;89(9):3323-3329.
Hehlmann R. Advancing a field by building consortia: the example of the European LeukemiaNet. Cancer. 2018;124(6):1100-1104.