A prospective, multicenter, observational study of long-term decitabine treatment in patients with myelodysplastic syndrome.

Publisher: Impact Journals Country of Publication: United States NLM ID: 101532965 Publication Model: Print Cited Medium: Internet ISSN: 1949-2553 (Electronic) Linking ISSN: 19492553 NLM ISO Abbreviation: Oncotarget Subsets: MEDLINE

Original Publication: Albany, N.Y. : Impact Journals

Antimetabolites, Antineoplastic/*administration & dosage ; Azacitidine/*analogs & derivatives ; Myelodysplastic Syndromes/*drug therapy; Administration, Intravenous ; Adult ; Aged ; Aged, 80 and over ; Antibiotic Prophylaxis ; Antimetabolites, Antineoplastic/adverse effects ; Azacitidine/administration & dosage ; Azacitidine/adverse effects ; Decitabine ; Disease Progression ; Disease-Free Survival ; Drug Administration Schedule ; Febrile Neutropenia/chemically induced ; Febrile Neutropenia/prevention & control ; Female ; Humans ; Kaplan-Meier Estimate ; Male ; Middle Aged ; Myelodysplastic Syndromes/diagnosis ; Myelodysplastic Syndromes/mortality ; Prospective Studies ; Remission Induction ; Republic of Korea ; Risk Factors ; Time Factors ; Treatment Outcome ; Young Adult

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.

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Keywords: decitabine; long-term treatment; myelodysplastic syndrome

0 (Antimetabolites, Antineoplastic)
776B62CQ27 (Decitabine)
M801H13NRU (Azacitidine)

Date Created: 20151031 Date Completed: 20161107 Latest Revision: 20181202

20240628

PMC4792606

10.18632/oncotarget.6242

26517692