Document Detail


Phase I/II study of decitabine in patients with myelodysplastic syndrome: a multi-center study in Japan.
MedLine Citation:
PMID:  22816487     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
The management of myelodysplastic syndrome (MDS) remains challenging. We performed a phase I/II study to evaluate the safety and efficacy of decitabine in patients with MDS in Japan. Patients with MDS with red cell transfusion dependence or 5-30% blasts in marrow and with an International Prognostic Scoring System score of intermediate-1 or higher were eligible. Patients received intravenous decitabine at 15 or 20 mg/m(2) daily for 5 days every 4 weeks. A total of 37 patients were enrolled. Three patients received 15 mg/m(2) and experienced no dose limiting toxicity during the first cycle. Thirty-four patients received 20 mg/m(2) . Grade 3 or greater non-hematologic toxicities included cerebral infarction (n = 1), subdural hematoma (n = 1), elevated blood glucose (n = 1), and pulmonary hypertension (n = 1). At 20 mg/m(2) , complete response, partial response, and hematologic improvement were observed in 7 (20.6%), 2 (5.9%), and 7 (20.6%) patients, respectively. Complete cytogenetic response was observed in 30% of evaluable 20 patients. The median number of cycles to clinical response was 4 (range 4-8), and duration of remission was 474+ days (range 294-598+). The 2-year rate of acute myeloid leukemia-free survival was 52%. Correlative studies revealed hypomethylation in multiple genes in peripheral blood cells after treatment. Hypomethylation was generally more profound in CD15 + peripheral blood cells, which reflects myeloid cells, than in peripheral blood mononuclear cells. In summary, decitabine was safe and demonstrated efficacy in Japanese patients with high-risk MDS. This trial was registered at ClinicalTrials.gov (NCT00796003).
Authors:
Yasuhiro Oki; Yutaka Kondo; Kazuhito Yamamoto; Michinori Ogura; Masanobu Kasai; Yukio Kobayashi; Takashi Watanabe; Naokuni Uike; Kazuma Ohyashiki; Shin-ichiro Okamoto; Kazunori Ohnishi; Akihiro Tomita; Yasushi Miyazaki; Kaoru Tohyama; Harumi Y Mukai; Tomomitsu Hotta; Masao Tomonaga
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Publication Detail:
Type:  Clinical Trial, Phase I; Clinical Trial, Phase II; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't     Date:  2012-09-14
Journal Detail:
Title:  Cancer science     Volume:  103     ISSN:  1349-7006     ISO Abbreviation:  Cancer Sci.     Publication Date:  2012 Oct 
Date Detail:
Created Date:  2012-10-09     Completed Date:  2012-12-10     Revised Date:  2013-06-03    
Medline Journal Info:
Nlm Unique ID:  101168776     Medline TA:  Cancer Sci     Country:  England    
Other Details:
Languages:  eng     Pagination:  1839-47     Citation Subset:  IM    
Copyright Information:
© 2012 Japanese Cancer Association.
Affiliation:
Department of Hematology and Cell Therapy, Aichi Cancer Center Hospital, Nagoya, Japan. yoki@mdanderson.org
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00796003
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MeSH Terms
Descriptor/Qualifier:
Aged
Antimetabolites, Antineoplastic / administration & dosage*,  adverse effects,  pharmacokinetics
Azacitidine / administration & dosage,  adverse effects,  analogs & derivatives*,  pharmacokinetics
Dose-Response Relationship, Drug
Female
Humans
Japan
Male
Middle Aged
Myelodysplastic Syndromes / drug therapy*
Treatment Outcome
Chemical
Reg. No./Substance:
0/Antimetabolites, Antineoplastic; 320-67-2/Azacitidine; 776B62CQ27/decitabine

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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