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Leukemia. 2018 Feb;32(2):413-418. doi: 10.1038/leu.2017.186. Epub 2017 Jun 13.

A phase II, multicentre trial of decitabine in higher-risk chronic myelomonocytic leukemia.

Author information

1
Department of Hematology, AOU Careggi, University of Florence, Florence, Italy.
2
AOU Citta della Salute e della Scienza, Torino, Italy.
3
Department of Oncology and Hematology, Hematology Institute, Fondazion e Policlinico Gemelli, UCSC, Rome, Italy.
4
Division of Haematology, Department of Translational Medicine, UPO, Novara, Italy.
5
Department of Hematology, AOU Ospedali Riuniti, Università Politecnica Marche, Ancona, Italy.
6
Department of Clinical and Biological Sciences, San Luigi Hospital, University of Turin, Turin, Italy.
7
Università degli studi di Firenze, Dipartimento di medicina sperimentale e Clinica, Firenze, Italy.
8
AOU Città della salute e della scienza di Torino, Torino, Italy.
9
Human Oncology and Pathogenesis Program, and Leukemia Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
10
BMT Centre of Perugia, Department of Hematology, Perugia, Italy.
11
Hematology and Transplant Unit, Ospedale Oncologico di Riferimento Regionale Armando Businco, Cagliari, Italy.
12
Institute of Hematology, S.Orsola-Malpighi University Hospital, Bologna, Italy.
13
Oncohematology Unit, Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico-Department of Oncology and Hemato-Oncology, University of Milan, Milan, Italy.
14
Spedali Civili Brescia Hematology Unit, Brescia, Italy.
15
Hematology Division, Università degli Studi di Torino, Torino, Italy.
16
Department of Clinical and Biological Sciences, University of Turin, Torino, Italy.
17
Department of Human Genetics and, Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine, Miami, FL, USA.

Abstract

Chronic myelomonocytic leukemia (CMML) is a complex clonal hematological disorder classified among myelodysplastic (MDS)/myeloproliferative neoplasms. Prognosis is poor and there is a lack of effective treatments. The hypomethylating agent decitabine has shown activity against MDS and elderly acute myeloid leukemia, but there is little data focusing specifically on its efficacy in CMML. In this prospective, phase 2 Italian study, CMML patients received intravenous decitabine 20 mg/m2 per day on Days 1-5 of a 28-day treatment cycle. Response was evaluated after four and six cycles; patients responding at the end of six cycles could continue treatment with decitabine. Forty-three patients were enrolled; >50% were high-risk according to four CMML-specific scoring systems. In the intent-to-treat population (n=42), the overall response rate after six cycles was 47.6%, with seven complete responses (16.6%), eight marrow responses (19%), one partial response (2.4%) and four hematological improvements (9.5%). After a median follow-up of 51.5 months (range: 44.4-57.2), median overall survival was 17 months, with responders having a significantly longer survival than non-responders (P=0.02). Grade 3/4 anemia, neutropenia and thrombocytopenia occurred in 28.6%, 50% and 38% of patients, respectively. Decitabine appears to be an effective and well-tolerated treatment for patients with high-risk CMML.

PMID:
28607470
PMCID:
PMC5808077
DOI:
10.1038/leu.2017.186
[Indexed for MEDLINE]
Free PMC Article

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