title: A prospective, multicenter, observational study of long-term decitabine treatment in patients with myelodysplastic syndrome.
abstract: This prospective observational study evaluated the efficacy and safety of long-term decitabine treatment in patients with myelodysplastic syndrome (MDS). Decitabine 20 mg/m(2)/day was administered intravenously for 5 consecutive days every 4 weeks to MDS patients in intermediate-1 or higher International Prognostic Scoring System (IPSS) risk categories. Active antimicrobial prophylaxis was given to prevent infectious complications. Overall response rate (ORR), overall survival (OS), progression-free survival (PFS), and time to response were evaluated, as were adverse events. The final analysis included 132 patients. IPSS risk was intermediate-2/high in 34.9% patients. The patients received a median of 5 cycles, with responders receiving a median of 8 cycles (range, 2-30). ORR was 62.9% (complete response [CR], 36; partial response [PR], 3; marrow complete response [mCR], 19; and hematologic improvement, 25). Among responders, 39% showed first response at cycle 3 or later. OS at 2 years was 60.9%, with 17% progressing to acute myeloid leukemia. PFS at 2 years was 51.0%. Patients achieving mCR showed comparable survival outcomes to those with CR/PR. With active antibiotic prophylaxis, febrile neutropenia events occurred in 61 of 1,033 (6%) cycles. Long-term decitabine treatment with antibiotic prophylaxis showed favorable outcomes in MDS patients, and mCR predicted favorable survival outcomes.
authors.affiliation: Department of Hematology-Oncology, Ajou University School of Medicine, Suwon, South Korea.
authors.forename: Seong Hyun
authors.initials: SH
authors.lastname: Jeong
authors.affiliation: Department of Hematology, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
authors.forename: Yoo-Jin
authors.initials: YJ
authors.lastname: Kim
authors.affiliation: Department of Hematology, Asan Medical Center, Seoul, Korea.
authors.forename: Je-Hwan
authors.initials: JH
authors.lastname: Lee
authors.affiliation: Department of Hematology, Chonnam National University Hwasun Hospital, Jeollanam-do, South Korea.
authors.forename: Yeo-Kyeoung
authors.initials: YK
authors.lastname: Kim
authors.affiliation: Division of Hematology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: Soo Jeong
authors.initials: SJ
authors.lastname: Kim
authors.affiliation: Department of Internal Medicine, Soonchunhyang University Hospital, Bucheon, South Korea.
authors.forename: Sung Kyu
authors.initials: SK
authors.lastname: Park
authors.affiliation: Division of Hematology-Oncology, School of Medicine, Keimyung University, Daegu, South Korea.
authors.forename: Young Rok
authors.initials: YR
authors.lastname: Do
authors.affiliation: Department of Internal Medicine, Seoul National University, Seoul, Korea.
authors.forename: Inho
authors.initials: I
authors.lastname: Kim
authors.affiliation: Department of Hematology and Oncology, School of Medicine, Ewha Womans University, Seoul, Korea.
authors.forename: Yeung-Chul
authors.initials: YC
authors.lastname: Mun
authors.affiliation: Division of Hematology-Oncology, Department of Internal Medicine, Gyeongnam Regional Cancer Center, Institute of Health Sciences, Gyeongsang National University School of Medicine, Jinju, South Korea.
authors.forename: Hoon Gu
authors.initials: HG
authors.lastname: Kim
authors.affiliation: Department of Internal Medicine, Inje University College of Medicine, Inje University Busan Paik Hospital, Busan, South Korea.
authors.forename: Won Sik
authors.initials: WS
authors.lastname: Lee
authors.affiliation: Department of Internal Medicine, Inha University College of Medicine, Incheon, South Korea.
authors.forename: Hyeon Gyu
authors.initials: HG
authors.lastname: Yi
authors.affiliation: Hematology-Oncology, Department of Internal Medicine, Inje University College of Medicine, Haeundae Paik Hospital, Busan, South Korea.
authors.forename: Young-Don
authors.initials: YD
authors.lastname: Joo
authors.affiliation: Division of Oncology and Hematology, Department of Internal Medicine, Korea University Medical Center, Seoul, Korea.
authors.forename: Chul Won
authors.initials: CW
authors.lastname: Choi
authors.affiliation: Janssen Korea Medical Affairs, Seoul, Korea.
authors.forename: Suk Ran
authors.initials: SR
authors.lastname: Kim
authors.affiliation: Janssen Korea Medical Affairs, Seoul, Korea.
authors.forename: Sang Min
authors.initials: SM
authors.lastname: Na
authors.affiliation: Division of Hematology and Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
authors.forename: Jun Ho
authors.initials: JH
authors.lastname: Jang
mesh_terms: D061605:Administration, Intravenous; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D019072:Antibiotic Prophylaxis; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage* / Q000009:adverse effects; D001374:Azacitidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000077209:Decitabine; D018450:Disease Progression; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D064147:Febrile Neutropenia / Q000139:chemically induced / Q000517:prevention & control; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009190:Myelodysplastic Syndromes / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality; D011446:Prospective Studies; D012074:Remission Induction; D056910:Republic of Korea; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000964:Antimetabolites, Antineoplastic; D000077209:Decitabine; D001374:Azacitidine
keywords: decitabine; long-term treatment; myelodysplastic syndrome