Prospective comparison of outcomes with azacitidine and decitabine in patients with AML ineligible for intensive chemotherapy

Zeidan, Amer M.; Fenaux, Pierre; Gobbi, Marco; Mayer, Jiřı́; Roboz, Gail J.; Krauter, Jürgen; Robak, Tadeusz; Kantarjian, Hagop M.; Novák, Jan; Wiktor-Jedrzejczak, W; Thomas, Xavier; Ojeda‐Uribe, Mario; Miyazaki, Yasushi; Min, Yoo Hong; Yeh, Su‐Peng; Brandwein, Joseph; Gercheva, Liana; Demeter, Judit; Griffiths, Elizabeth A.; Yee, Karen; Issa, Jean-Pierre J.; Bewersdorf, Jan Philipp; Keer, Harold; Hao, Yong; Azab, Mohammad; Döhner, Hartmut

doi:10.1182/blood.2022015832

Cited by 22 publications

(8 citation statements)

References 10 publications

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“…When only those studies using standard doses for both HMAs were included, they also found no difference in OS when comparing AZA and DEC, and the median OS observed was very similar to our study (10.83 months vs. 8.46 months, for AZA and DEC, respectively) [10]. An interesting post-hoc analysis from patients treated in the control arm of the ASTRAL-1 trial compared AZA vs. DEC and also showed no differences [9].…”

Section: Discussionsupporting

confidence: 83%

“…Similarly, in the Phase 3 AML-001 trial, AZA patients exhibited a median OS (10.4 months, 95% CI: 8.0-12.7) compared to conventional care regimens, considered standard IC, LDAC or BSC (6.5 months, 95% CI: 5.0-8.6) [6]. However, there are no clinical trials comparing the efficacy of AZA vs. DEC, and there are only a few studies evaluating and comparing their outcomes [7][8][9][10]. To select the most appropriate HMA, as a backbone for combination or in monotherapy, could be relevant to optimize the management of unfit patients.…”

Section: Introductionmentioning

confidence: 99%

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Azacitidine vs. Decitabine in Unfit Newly Diagnosed Acute Myeloid Leukemia Patients: Results from the PETHEMA Registry

Labrador

Martínez‐Cuadrón

Ramos

et al. 2022

Cancers

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The hypomethylating agents, decitabine (DEC) and azacitidine (AZA), allowed more elderly acute myeloid leukemia (AML) patients to be treated. However, there are little direct comparative data on AZA and DEC. This multicenter retrospective study compared the outcomes of AZA and DEC in terms of response and overall survival (OS). Potential predictors associated with response and OS were also evaluated. A total of 626 AML patients were included (487 treated with AZA and 139 with DEC). Response rates were similar in both groups: CR was 18% with AZA vs. 23% with DEC (p = 0.20), CR/CRi was 20.5% vs. 25% (p = 0.27) and ORR was 32% vs. 39.5% (p = 0.12), respectively. Patients with leukocytes < 10 × 109/L, bone marrow blasts < 50% and ECOG ≥ 2 had higher ORR with DEC than with AZA. OS was similar in both groups: 10.4 months (95% CI: 9.2–11.7) vs. 8.8 months (95% CI: 6.7–11.0, p = 0.455), for AZA and DEC, respectively. Age (≥80 years), leukocytes (≥ 10 × 109/L), platelet count (<20 × 109/L) and eGFR (≥45 mL/min/1.73 m2) were associated with higher OS with AZA compared to DEC. In conclusion, we found no differences in response and OS rates in AML patients treated with AZA or DEC.

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Section: Discussionsupporting

confidence: 83%

Section: Introductionmentioning

confidence: 99%

Azacitidine vs. Decitabine in Unfit Newly Diagnosed Acute Myeloid Leukemia Patients: Results from the PETHEMA Registry

Labrador

Martínez‐Cuadrón

Ramos

et al. 2022

Cancers

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“…Table 2 summarizes some of the major differences among the commercially‐available HMA formulations. It should be noted that although there have been no randomized comparisons between parental azacitidine and decitabine, several retrospective analyses suggest similar efficacy at the approved doses in both MDS and in AML 51,68,69 . However, the comparative efficacy of parental and oral formulations of these agents are not well‐established.…”

Section: Choosing Among Hma Formulationsmentioning

confidence: 99%

Hypomethylating agents for the treatment of myelodysplastic syndromes and acute myeloid leukemia: Past discoveries and future directions

Short

Kantarjian

2022

American J Hematol

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Azacitidine and decitabine are hypomethylating agents that have dose-dependent epigenetic and cytotoxic effects and are widely used in the treatment of myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). In this review, we discuss the path to regulatory approval of azacitidine and decitabine, highlighting the substantial efforts that have been made to optimize the dosing schedule and administration of these drugs, including the development of new, oral formulations of both agents. We also review novel combination strategies that are being investigated in ongoing clinical trials for patients with MDS and AML, as well as efforts to expand the current indications of these agents.

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“…Therefore, participation of patients not eligible for HSCT in clinical trials is strongly recommended, especially after HMA failure [73,74]. Of note is that no difference in rates of CR, ORR and survival has been shown between the two drugs AZA and DEC, and this finding has been demonstrated not only in MDS but also in AML patients unfit for intensive chemotherapy [75,76].…”

Section: Treatment Of Higher-risk Mdsmentioning

confidence: 99%

How I Manage Transplant Ineligible Patients with Myelodysplastic Neoplasms

2022

Self Cite

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Myelodysplastic neoplasms, formerly known as myelodysplastic syndromes (MDS), represent a group of clonal disorders characterized by a high degree of clinical and molecular heterogeneity, and an invariable tendency to progress to acute myeloid leukemia. MDS typically present in the elderly with cytopenias of different degrees and bone marrow dysplasia, the hallmarks of the disease. Allogeneic hematopoietic stem cell transplant is the sole curative approach to date. Nonetheless, given the disease’s demographics, only a minority of patients can benefit from this procedure. Currently used prognostic schemes such as the Revised International Prognostic Scoring System (R-IPSS), and most recently the molecular IPSS (IPSS-M), guide clinical management by dividing MDS into two big categories: lower- and higher-risk cases, based on a cut-off score of 3.5. The main clinical problem of the lower-risk group is represented by the management of cytopenias, whereas the prevention of secondary leukemia progression is the goal for the latter. Herein, we discuss the non-transplant treatment of MDS, focusing on current practice and available therapeutic options, while also presenting new investigational agents potentially entering the MDS therapeutic arsenal in the near future.

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Prospective comparison of outcomes with azacitidine and decitabine in patients with AML ineligible for intensive chemotherapy

Cited by 22 publications

References 10 publications

Azacitidine vs. Decitabine in Unfit Newly Diagnosed Acute Myeloid Leukemia Patients: Results from the PETHEMA Registry

Azacitidine vs. Decitabine in Unfit Newly Diagnosed Acute Myeloid Leukemia Patients: Results from the PETHEMA Registry

Hypomethylating agents for the treatment of myelodysplastic syndromes and acute myeloid leukemia: Past discoveries and future directions

How I Manage Transplant Ineligible Patients with Myelodysplastic Neoplasms

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