Cited by 2,663Acute Myeloid Leukemia ResearchRetinoids in leukemia and cellular processesHematopoietic Stem Cell Transplantation

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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

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Fenaux, Pierre, Mufti, Ghulam J, Hellstrom-Lindberg, Eva, Santini, Valeria, Finelli, Carlo, Giagounidis, Aristoteles, Schoch, Robert, Gattermann, Norbert, Sanz, Guillermo, List, Alan, Gore, Steven D, Seymour, John F, Bennett, John M, Byrd, John, Backstrom, Jay, Zimmerman, Linda, McKenzie, David, Beach, CL, Silverman, Lewis R·2009·The Lancet Oncology

DOI 10.1016/s1470-2045(09)70003-8PMC PMC4086808

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Abstract

Background 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.Methods 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.Findings 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.Interpretation Treatment with azacitidine increases overall survival in patients with higher-risk myelodysplastic syndromes relative to conventional care.

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Low‐dose azacitidine maintenance therapy after allogeneic stem cell transplantation for high‐risk pediatric acute myeloid leukemia
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“Of interest, the infection rate in azacitidine-treated patients was significantly lower than in those receiving low-dose cytarabine or intensive chemotherapy, resulting in a 34% reduction in the rate of infection [11].”
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Danazol as First-Line Therapy for Myelodysplastic Syndrome
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Acute myeloid leukemia with inv(3)(q21.3q26.2)/t(3;3)(q21.3;q26.2): Study of 61 patients treated with intensive protocols
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“Age in yrs, median (range) Age ≥60, N (%) 55 (16-84) 43 (41) 63 (16-84) 29 (53) 48 (18-83) 16 (30) <0.”
Influential
Autophagy degrades immunogenic endogenous retroelements induced by 5-azacytidine in acute myeloid leukemia
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“While both HMAs have similar response rates in AML (8), only AZA significantly improves overall survival compared with conventional care regimens in phase III randomized trials (9,10).”
Background
Higher Infection Rate After 7- Compared With 5-Day Cycle of Azacitidine in Patients With Higher-Risk Myelodysplastic Syndrome
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Self-citation
A rapid screening system evaluates novel inhibitors of DNA methylation and suggests F-box proteins as potential therapeutic targets for high-risk neuroblastoma
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“,([105]) in a prospective, randomized phase III trial, demonstrated that use of azacytidine is better than ‘conventional care regimens’ (low-dose cytarabine, intensive chemotherapy or best supportive care) in patients with 20–30% bone marrow blasts.”
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Epigenetic dysregulation of GATA1 is involved in myelodysplastic syndromes dyserythropoiesis
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“It has been frequently reported in MDS (43–46), and clinical response to demethylating therapy supports the concept of its essential pathogenetic role (47, 48).”
Background
Application of French prognostic score to patients with International Prognostic Scoring System intermediate-2 or high risk myelodysplastic syndromes treated with 5-azacitidine is able to predict overall survival and rate of response
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“There was also an azacitidineassociated delay noted as far as the time to leukemic transformation was concerned [11, 12].”
BackgroundSelf-citation
TP53 and IDH2 Somatic Mutations Are Associated With Inferior Overall Survival After Allogeneic Hematopoietic Cell Transplantation for Myelodysplastic Syndrome
Kharfan‐Dabaja, M. A., Komrokji, R. S., Zhang, Q., Kumar, A., Tsalatsanis, A., Perkins, J., Nishihori, T., Field, T. L., Ali, N. E. A., Mishra, A., et al. (2017) · Clinical Lymphoma Myeloma & Leukemia · doi:10.1016/j.clml.2017.06.003 · Cited by 24
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Real Life Data on Efficacy and Safety of Azacitidine Therapy for Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia and Acute Myeloid Leukemia
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“Two phase-III studies demonstrated a survival benefit of AZA over conventional care regimen [16, 17].”
Background
Dendritic Cells in Myelodysplastic Syndromes: From Pathogenesis to Immunotherapy
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Clinical response to azacitidine in MDS is associated with distinct DNA methylation changes in HSPCs
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High levels of global DNA methylation are an independent adverse prognostic factor in a series of 90 patients with de novo myelodysplastic syndrome
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Activin Receptor II Ligand Traps and Their Therapeutic Potential in Myelodysplastic Syndromes with Ring Sideroblasts
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RETRACTED ARTICLE: LAMP2 expression dictates azacytidine response and prognosis in MDS/AML
Dubois, A., Furstoss, N., Calleja, A., Zerhouni, M., Cluzeau, T., Savy, C., Marchetti, S., Hamouda, M. A., Boulakirba, S., Orange, F., et al. (2019) · Leukemia · doi:10.1038/s41375-018-0336-1 · Cited by 22
Retracted
Oral Azacitidine (CC-486) for the Treatment of Myeloid Malignancies
Garcia‐Manero, G., Döhner, H., Wei, A. H., Torre, I. L., Skikne, B., Beach, C. L., & Santini, V. (2021) · Clinical Lymphoma Myeloma & Leukemia · doi:10.1016/j.clml.2021.09.021 · Cited by 22
Self-citation
Emerging treatments for myelodysplastic syndromes: Biological rationales and clinical translation
Rodríguez‐Sevilla, J. J., Ademà, V., Garcia‐Manero, G., & Colla, S. (2023) · Cell Reports Medicine · doi:10.1016/j.xcrm.2023.100940 · Cited by 23
“The current standard of care for patients with MDS remains therapy with hypomethylating agents (HMAs), such as 5-azacytidine (5-aza) and its analog 5-aza-20-deoxycytidine (decitabine), which results in clinical improvements in over 50% of patients.(4,5) According to the International Working Group,(6) primary HMA fail…”
Background

Authors: Fenaux, P., Mufti, G. J., Hellstrom-Lindberg, E., Santini, V., Finelli, C., Giagounidis, A., Schoch, R., Gattermann, N., Sanz, G., List, A., Gore, S. D., Seymour, J. F., Bennett, J. M., Byrd, J., Backstrom, J., Zimmerman, L., McKenzie, D., Beach, C., & Silverman, L. R.
Affiliations: Université Sorbonne Paris Nord (FR)
King's College Hospital (GB)
Azienda Ospedaliero-Universitaria Careggi (IT)
University Hospital Schleswig-Holstein (DE)
Düsseldorf University Hospital (DE)
Hospital Universitari i Politècnic La Fe (ES)
Moffitt Cancer Center (US)
Johns Hopkins University (US)
Karolinska University Hospital (SE)
University of Rochester Medicine (US)
The Ohio State University (US)
Celgene (United States) (US)
Icahn School of Medicine at Mount Sinai (US)
Corresponding author: Fenaux, Pierre
ORCID: Fenaux, Pierre
Mufti, Ghulam J
Santini, Valeria
Finelli, Carlo
Giagounidis, Aristoteles
Sanz, Guillermo
List, Alan
Gore, Steven D
Seymour, John F
Bennett, John M
Byrd, John
Silverman, Lewis R
Venue: The Lancet Oncology
Publisher: Elsevier BV
Published: 2009-03
Volume: 10
Issue: 3
Pages: 223-232
ISSN: 1470-2045 (ISSN-L)
DOI: 10.1016/s1470-2045(09)70003-8
PMC: PMC4086808
OpenAlex: W2118771330
Cited by: 2,663
References: 45
Citations by year: 2026: 80 · 2025: 99 · 2024: 103 · 2023: 153 · 2022: 149 · 2021: 182 · 2020: 148 · 2019: 149 · 2018: 132 · 2017: 164 · 2016: 178 · 2015: 173 · 2014: 201 · 2013: 182 · 2012: 178
FWCI: 124.66
Type: journal article
Language: en
Open access: green
www.ncbi.nlm.nih.gov
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
www.elsevier.com/legal/tdmrep-license (tdm)
Locations: The Lancet Oncology (publishedVersion)
PubMed (publishedVersion)
Europe PMC (PubMed Central) (acceptedVersion)
PubMed Central (acceptedVersion)
Florence Research (University of Florence) (submittedVersion)
IRIS UNIMORE (University of Modena and Reggio Emilia) (submittedVersion, cc-by)
Research Portal (King's College London) (submittedVersion)
Funders: Celgene
National Cancer Institute (K24CA111717)
Topics: Health Sciences › Medicine › Hematology › Acute Myeloid Leukemia Research
Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Retinoids in leukemia and cellular processes
Health Sciences › Medicine › Hematology › Hematopoietic Stem Cell Transplantation
Keywords: azacitidine, myelodysplastic syndrome, high-risk myelodysplastic syndrome, overall survival, low-dose cytarabine, intensive chemotherapy, best supportive care, hypomethylating agents, treatment efficacy comparison, hematologic malignancies
MeSH terms: Adult, Aged, Aged, 80 and over, Antimetabolites, Antineoplastic, Azacitidine, Female, Humans, Male, Middle Aged, Myelodysplastic Syndromes, Proportional Hazards Models

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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

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