A phase II study of guadecitabine in higher-risk myelodysplastic syndrome and low blast count acute myeloid leukemia after azacitidine failure.
Journal
Haematologica
ISSN: 1592-8721
Titre abrégé: Haematologica
Pays: Italy
ID NLM: 0417435
Informations de publication
Date de publication:
08 2019
08 2019
Historique:
received:
05
10
2018
accepted:
07
02
2019
pubmed:
9
2
2019
medline:
24
7
2020
entrez:
9
2
2019
Statut:
ppublish
Résumé
High-risk myelodysplastic syndrome/acute myeloid leukemia patients have a very poor survival after azacitidine failure. Guadecitabine (SGI-110) is a novel subcutaneous hypomethylating agent which results in extended decitabine exposure. This multicenter phase II study evaluated the efficacy and safety of guadecitabine in high-risk myelodysplastic syndrome and low blast count acute myeloid leukemia patients refractory or relapsing after azacitidine. We included 56 patients with a median age of 75 years [Interquartile Range (IQR) 69-76]. Fifty-five patients received at least one cycle of guadecitabine (60 mg/m2/d subcutaneously days 1-5 per 28-day treatment cycles), with a median of 3 cycles (range, 0-27). Eight (14.3%) patients responded, including two complete responses; median response duration was 11.5 months. Having no or few identified somatic mutations was the only factor predicting response (
Identifiants
pubmed: 30733271
pii: haematol.2018.207118
doi: 10.3324/haematol.2018.207118
pmc: PMC6669173
doi:
Substances chimiques
guadecitabine
2KT4YN1DP7
Azacitidine
M801H13NRU
Types de publication
Clinical Trial, Phase II
Journal Article
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
1565-1571Informations de copyright
Copyright© 2019 Ferrata Storti Foundation.
Références
Lancet Oncol. 2009 Mar;10(3):223-32
pubmed: 19230772
Clin Epigenetics. 2013 Feb 01;5(1):3
pubmed: 23369223
N Engl J Med. 2016 Nov 24;375(21):2023-2036
pubmed: 27959731
Haematologica. 2016 Jun;101(6):e224-7
pubmed: 26992944
Leuk Res. 2015 May;39(5):501-4
pubmed: 25735917
Leuk Lymphoma. 2008 Apr;49(4):690-5
pubmed: 18398735
Oncotarget. 2018 Jan 3;9(11):9714-9727
pubmed: 29515765
Blood. 2006 Jul 15;108(2):419-25
pubmed: 16609072
J Clin Oncol. 2012 Jul 20;30(21):2670-7
pubmed: 22689805
Clin Cancer Res. 2009 Jun 15;15(12):3938-46
pubmed: 19509174
Ann Intern Med. 1985 Sep;103(3):460-2
pubmed: 2411180
Mol Cancer Ther. 2010 May;9(5):1443-50
pubmed: 20442312
Leukemia. 2011 Jul;25(7):1147-52
pubmed: 21494260
Blood. 2014 Oct 23;124(17):2705-12
pubmed: 25224413
J Clin Oncol. 2011 May 20;29(15):1987-96
pubmed: 21483003
Blood. 2009 Jul 30;114(5):937-51
pubmed: 19357394
J Clin Oncol. 2011 Aug 20;29(24):3322-7
pubmed: 21788559
Cancer. 2018 Jan 15;124(2):325-334
pubmed: 29211308
Blood. 1997 Mar 15;89(6):2079-88
pubmed: 9058730
Lancet Oncol. 2017 Oct;18(10):1317-1326
pubmed: 28844816
Leuk Lymphoma. 2015 Jun;56(6):1718-22
pubmed: 25263320
Lancet Oncol. 2015 Sep;16(9):1099-1110
pubmed: 26296954