Abstract | BACKGROUND: DESIGN AND METHODS:
Decitabine 20 mg/m(2)/day was given intravenously over one hour for five consecutive days every four weeks. The primary end point was overall response rate. RESULTS: A total of 101 patients were analyzed. The International Prognostic Scoring System risk category was Intermediate-2/High in 47.5%. A median of 5 courses (range 1-18) were delivered. The overall response rate was 55.4% (13 complete responses, one partial response, 23 marrow complete responses, and 19 hematologic improvements). Forty-eight patients (47.5%) showed some hematologic improvement. With a median follow-up duration of 478 days (range 69-595), median overall survival was 17.7 months. Patients who showed hematologic improvement had significantly longer overall survival than those who did not (19.2 vs. 15.9 months, P=0.006 by landmark analysis at six months). The difference in overall survival was evident in the Intermediate-2/High risk group but not in the Intermediate-1 risk group. The progression-free survival and acute myeloid leukemia-free survival were 61.9% and 77.9% at one year, respectively. Among 489 assessable treatment courses, there were 97 fever episodes requiring intravenous antimicrobials. CONCLUSIONS:
Decitabine treatment was feasible and effective in Korean patients with myelodysplastic syndrome, and the overall survival was significantly longer in patients showing hematologic improvement.
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Authors | Je-Hwan Lee, Jun Ho Jang, Jinny Park, Seonyang Park, Young-Don Joo, Yeo-Kyeoung Kim, Hoon-Gu Kim, Chul Won Choi, Sung-Hyun Kim, Seong Kyu Park, Eunkyung Park, Yoo Hong Min |
Journal | Haematologica
(Haematologica)
Vol. 96
Issue 10
Pg. 1441-7
(Oct 2011)
ISSN: 1592-8721 [Electronic] Italy |
PMID | 21659363
(Publication Type: Clinical Trial, Journal Article, Multicenter Study)
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Chemical References |
- Antimetabolites, Antineoplastic
- Decitabine
- Azacitidine
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Topics |
- Adult
- Aged
- Aged, 80 and over
- Antimetabolites, Antineoplastic
(adverse effects, therapeutic use)
- Azacitidine
(adverse effects, analogs & derivatives, therapeutic use)
- Decitabine
- Female
- Hematopoietic Stem Cell Transplantation
- Humans
- Kaplan-Meier Estimate
- Male
- Middle Aged
- Myelodysplastic Syndromes
(diagnosis, drug therapy, mortality)
- Prognosis
- Prospective Studies
- Republic of Korea
- Transplantation, Homologous
- Treatment Outcome
- Young Adult
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