Clinical Research Papers:
A prospective, multicenter, observational study of long-term decitabine treatment in patients with myelodysplastic syndrome
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Abstract
Seong Hyun Jeong1, Yoo-Jin Kim2, Je-Hwan Lee3, Yeo-Kyeoung Kim4, Soo Jeong Kim5, Sung Kyu Park6, Young Rok Do7, Inho Kim8, Yeung-Chul Mun9, Hoon Gu Kim10, Won Sik Lee11, Hyeon Gyu Yi12, Young-Don Joo13, Chul Won Choi14, Suk Ran Kim15, Sang Min Na15 and Jun Ho Jang16,*
1 Department of Hematology-Oncology, Ajou University School of Medicine, Suwon, South Korea
2 Department of Hematology, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
3 Department of Hematology, Asan Medical Center, Seoul, Korea
4 Department of Hematology, Chonnam National University Hwasun Hospital, Jeollanam-do, South Korea
5 Division of Hematology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea
6 Department of Internal Medicine, Soonchunhyang University Hospital, Bucheon, South Korea
7 Division of Hematology-Oncology, School of Medicine, Keimyung University, Daegu, South Korea
8 Department of Internal Medicine, Seoul National University, Seoul, Korea
9 Department of Hematology and Oncology, School of Medicine, Ewha Womans University, Seoul, Korea
10 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
11 Department of Internal Medicine, Inje University College of Medicine, Inje University Busan Paik Hospital, Busan, South Korea
12 Department of Internal Medicine, Inha University College of Medicine, Incheon, South Korea
13 Hematology-Oncology, Department of Internal Medicine, Inje University College of Medicine, Haeundae Paik Hospital, Busan, South Korea
14 Division of Oncology and Hematology, Department of Internal Medicine, Korea University Medical Center, Seoul, Korea
15 Janssen Korea Medical Affairs, Seoul, Korea
16 Division of Hematology and Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
* For the Korean Society of Hematology AML/MDS Working Party
Correspondence to:
Jun Ho Jang, email:
Keywords: decitabine, long-term treatment, myelodysplastic syndrome
Received: August 10, 2015 Accepted: September 24, 2015 Published: October 26, 2015
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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