title: A prospective multicenter observational study of decitabine treatment in Korean patients with myelodysplastic syndrome.
abstract: BACKGROUND
  Decitabine was evaluated for its efficacy and safety in Korean patients with myelodysplastic syndrome with IPSS score of 0.5 or over.
  
  
  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.
authors.affiliation: Department of Hematology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea. jhlee3@amc.seoul.kr
authors.forename: Je-Hwan
authors.initials: JH
authors.lastname: Lee
authors.forename: Jun Ho
authors.initials: JH
authors.lastname: Jang
authors.forename: Jinny
authors.initials: J
authors.lastname: Park
authors.forename: Seonyang
authors.initials: S
authors.lastname: Park
authors.forename: Young-Don
authors.initials: YD
authors.lastname: Joo
authors.forename: Yeo-Kyeoung
authors.initials: YK
authors.lastname: Kim
authors.forename: Hoon-Gu
authors.initials: HG
authors.lastname: Kim
authors.forename: Chul Won
authors.initials: CW
authors.lastname: Choi
authors.forename: Sung-Hyun
authors.initials: SH
authors.lastname: Kim
authors.forename: Seong Kyu
authors.initials: SK
authors.lastname: Park
authors.forename: Eunkyung
authors.initials: E
authors.lastname: Park
authors.forename: Yoo Hong
authors.initials: YH
authors.lastname: Min
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000009:adverse effects / Q000627:therapeutic use*; D001374:Azacitidine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000077209:Decitabine; D005260:Female; D018380:Hematopoietic Stem Cell Transplantation; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009190:Myelodysplastic Syndromes / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality; D011379:Prognosis; D011446:Prospective Studies; D056910:Republic of Korea; D014184:Transplantation, Homologous; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000964:Antimetabolites, Antineoplastic; D000077209:Decitabine; D001374:Azacitidine