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- Title
Phase I/II study of decitabine in patients with myelodysplastic syndrome: a multi-center study in Japan.
- Authors
Oki, Yasuhiro; Kondo, Yutaka; Yamamoto, Kazuhito; Ogura, Michinori; Kasai, Masanobu; Kobayashi, Yukio; Watanabe, Takashi; Uike, Naokuni; Ohyashiki, Kazuma; Okamoto, Shin-ichiro; Ohnishi, Kazunori; Tomita, Akihiro; Miyazaki, Yasushi; Tohyama, Kaoru; Mukai, Harumi Y; Hotta, Tomomitsu; Tomonaga, Masao
- Abstract
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).
- Publication
Cancer science, 2012, Vol 103, Issue 10, p1839
- ISSN
1349-7006
- Publication type
Journal Article
- DOI
10.1111/j.1349-7006.2012.02386.x