| A phase I/II study of decitabine in patients with myelodysplastic syndrome: a multi-center study in Japan. | |
| | |
MedLine Citation:
|
PMID: 22816487 Owner: NLM Status: Publisher |
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 mg/m(2) 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 to 8), and duration of remission was 474+ days (range 294-598+). The two-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 |
Related Documents
:
|
17826557 - Clinical manifestations of type iv ulna longitudinal dysplasia. 21772157 - Wide optic nerve canal decompression for the treatment of blindness resulting from an i... 21949527 - Relation between high-sensitivity c-reactive protein and coronary plaque components in ... 18534437 - Cell therapy for secondary osteonecrosis of the femoral condyles using the cellect dbm ... 6158997 - Oxygen dissociation curve in eales's disease. 17998147 - Nodular regenerative hyperplasia: the main liver disease in patients with primary hypog... |
Publication Detail:
|
Type: JOURNAL ARTICLE Date: 2012-7-21 |
Journal Detail:
|
Title: Cancer science Volume: - ISSN: 1349-7006 ISO Abbreviation: - Publication Date: 2012 Jul |
Date Detail:
|
Created Date: 2012-7-23 Completed Date: - Revised Date: - |
Medline Journal Info:
|
Nlm Unique ID: 101168776 Medline TA: Cancer Sci Country: - |
Other Details:
|
Languages: ENG Pagination: - Citation Subset: - |
Copyright Information:
|
© 2012 Japanese Cancer Association. |
Affiliation:
|
Department of Hematology and Cell Therapy, Aichi Cancer Center Hospital, Nagoya, Japan. |
Export Citation:
|
APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
|
|
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
Previous Document: Delay of flower senescence by bacterial endophytes expressing ACC deaminase.
Next Document: A novel primer set for multilocus phylogenetic inference in East African cichlid fishes.