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A prospective multicenter observational study of decitabine treatment in Korean patients with myelodysplastic syndrome.

AbstractBACKGROUND:
Decitabine was evaluated for its efficacy and safety in Korean patients with myelodysplastic syndrome with IPSS score of 0.5 or over.
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.
AuthorsJe-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
JournalHaematologica (Haematologica) Vol. 96 Issue 10 Pg. 1441-7 (Oct 2011) ISSN: 1592-8721 [Electronic] Italy
PMID21659363 (Publication Type: Clinical Trial, Journal Article, Multicenter Study)
Chemical References
  • Antimetabolites, Antineoplastic
  • decitabine
  • Azacitidine
Topics
  • Adult
  • Aged
  • Aged, 80 and over
  • Antimetabolites, Antineoplastic (adverse effects, therapeutic use)
  • Azacitidine (adverse effects, analogs & derivatives, therapeutic use)
  • 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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