A phase II randomized study evaluating azacitidine versus conventional care regimens in newly diagnosed elderly Japanese patients with unfavorable acute myeloid leukemia.
Acute myeloid leukemia
Azacitidine
Front-line therapy
Japanese patients
Phase 2 study
Journal
International journal of hematology
ISSN: 1865-3774
Titre abrégé: Int J Hematol
Pays: Japan
ID NLM: 9111627
Informations de publication
Date de publication:
May 2022
May 2022
Historique:
received:
17
11
2021
accepted:
06
02
2022
revised:
03
02
2022
pubmed:
26
2
2022
medline:
30
4
2022
entrez:
25
2
2022
Statut:
ppublish
Résumé
A multicenter phase II study was conducted in 44 elderly (≥ 65 years) Japanese patients with newly diagnosed acute myeloid leukemia (AML) to evaluate whether azacitidine is also effective and feasible in Japanese AML patients. The 28 patients with AML with poor-risk cytogenetics and/or myelodysplasia-related changes (unfavorable AML) were randomly assigned to receive either azacitidine or conventional care regimens (CCR), and the other 16 patients without unfavorable AML received azacitidine alone. The primary endpoint was overall survival. At the median follow-up of 29 months, among the 26 evaluable patients with unfavorable AML, the median survival time (MST) of patients who received azacitidine (N = 14) was 9.6 months and that of patients who received CCR (N = 12) was 5.3 months (HR 0.73; 95% CI 0.31-1.69; log-rank P = 0.459). The MST of all 29 patients who received azacytidine, including the 15 evaluable patients without unfavorable AML, was 12.4 months. Adverse events of azacitidine were manageable and consistent with its established safety profile. Azacitidine tended to prolong survival in newly diagnosed elderly Japanese patients with AML, and was feasible as a front-line therapy for elderly AML patients.
Identifiants
pubmed: 35211840
doi: 10.1007/s12185-022-03307-x
pii: 10.1007/s12185-022-03307-x
doi:
Substances chimiques
Antimetabolites, Antineoplastic
0
Azacitidine
M801H13NRU
Types de publication
Clinical Trial, Phase II
Journal Article
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
694-703Investigateurs
Kensuke Usuki
(K)
Kiyoshi Ando
(K)
Takahiro Yamauchi
(T)
Junya Kuroda
(J)
Takayuki Ishikawa
(T)
Hiromi Iwasaki
(H)
Takahiro Suzuki
(T)
Kenichi Kitamura
(K)
Hitoji Uchiyama
(H)
Satoshi Ichikawa
(S)
Kenji Imajo
(K)
Hitoshi Hanamoto
(H)
Shuichi Miyawaki
(S)
Noriko Usui
(N)
Norio Asou
(N)
Akihiro Hirakawa
(A)
Kazutaka Kuriyama
(K)
Masakazu Muta
(M)
Masafumi Taniwaki
(M)
Yukari Takahashi
(Y)
Atsushi Dohi
(A)
Yoko Nakanishi
(Y)
Ryuhei Nakaoka
(R)
Informations de copyright
© 2022. Japanese Society of Hematology.
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