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

Seong Hyun Jeong, Yoo Jin Kim, Je Hwan Lee, Yeo Kyeoung Kim, Soo Jeong Kim, Sung Kyu Park, Young Rok Do, Inho Kim, Yeung Chul Mun, Hoon Gu Kim, Won Sik Lee, Hyeon Gyu Yi, Young Don Joo, Chul Won Choi, Suk Ran Kim, Sang Min Na, Jun Ho Jang

Research output: Contribution to journalArticle

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Abstract

This prospective observational study evaluated the efficacy and safety of long-term decitabine treatment in patients with myelodysplastic syndrome (MDS). Decitabine 20 mg/m2/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.

Original languageEnglish
Pages (from-to)44985-44994
Number of pages10
JournalOncotarget
Volume6
Issue number42
DOIs
Publication statusPublished - 2015 Jan 1

Fingerprint

decitabine
Myelodysplastic Syndromes
Multicenter Studies
Observational Studies
Antibiotic Prophylaxis
Bone Marrow
Therapeutics
Disease-Free Survival
Survival
Febrile Neutropenia
Acute Myeloid Leukemia
Survival Rate

Keywords

  • Decitabine
  • Long-term treatment
  • Myelodysplastic syndrome

ASJC Scopus subject areas

  • Oncology

Cite this

Jeong, S. H., Kim, Y. J., Lee, J. H., Kim, Y. K., Kim, S. J., Park, S. K., ... Jang, J. H. (2015). A prospective, multicenter, observational study of long-term decitabine treatment in patients with myelodysplastic syndrome. Oncotarget, 6(42), 44985-44994. https://doi.org/10.18632/oncotarget.6242

A prospective, multicenter, observational study of long-term decitabine treatment in patients with myelodysplastic syndrome. / Jeong, Seong Hyun; Kim, Yoo Jin; Lee, Je Hwan; Kim, Yeo Kyeoung; Kim, Soo Jeong; Park, Sung Kyu; Do, Young Rok; Kim, Inho; Mun, Yeung Chul; Kim, Hoon Gu; Lee, Won Sik; Yi, Hyeon Gyu; Joo, Young Don; Choi, Chul Won; Kim, Suk Ran; Na, Sang Min; Jang, Jun Ho.

In: Oncotarget, Vol. 6, No. 42, 01.01.2015, p. 44985-44994.

Research output: Contribution to journalArticle

Jeong, SH, Kim, YJ, Lee, JH, Kim, YK, Kim, SJ, Park, SK, Do, YR, Kim, I, Mun, YC, Kim, HG, Lee, WS, Yi, HG, Joo, YD, Choi, CW, Kim, SR, Na, SM & Jang, JH 2015, 'A prospective, multicenter, observational study of long-term decitabine treatment in patients with myelodysplastic syndrome', Oncotarget, vol. 6, no. 42, pp. 44985-44994. https://doi.org/10.18632/oncotarget.6242
Jeong, Seong Hyun ; Kim, Yoo Jin ; Lee, Je Hwan ; Kim, Yeo Kyeoung ; Kim, Soo Jeong ; Park, Sung Kyu ; Do, Young Rok ; Kim, Inho ; Mun, Yeung Chul ; Kim, Hoon Gu ; Lee, Won Sik ; Yi, Hyeon Gyu ; Joo, Young Don ; Choi, Chul Won ; Kim, Suk Ran ; Na, Sang Min ; Jang, Jun Ho. / A prospective, multicenter, observational study of long-term decitabine treatment in patients with myelodysplastic syndrome. In: Oncotarget. 2015 ; Vol. 6, No. 42. pp. 44985-44994.
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abstract = "This prospective observational study evaluated the efficacy and safety of long-term decitabine treatment in patients with myelodysplastic syndrome (MDS). Decitabine 20 mg/m2/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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