Clinical Outcomes of Decitabine Treatment for Patients With Lower-Risk Myelodysplastic Syndrome on the Basis of the International Prognostic Scoring System

Ki Sun Jung; Yoo Jin Kim; Yeo Kyeoung Kim; Sung Kyu Park; Hoon Gu Kim; Soo Jeong Kim; Jinny Park; Chul Won Choi; Young Rok Do; Inho Kim; Seonyang Park; Yeung Chul Mun; Seong Hyun Jeong; Min Kyoung Kim; Hyeon Gyu Yi; Myung Hee Chang; Su Youn Kim; Je Hwan Lee; Jun Ho Jang

doi:10.1016/j.clml.2019.06.003

Clinical Outcomes of Decitabine Treatment for Patients With Lower-Risk Myelodysplastic Syndrome on the Basis of the International Prognostic Scoring System

Ki Sun Jung, Yoo Jin Kim, Yeo Kyeoung Kim, Sung Kyu Park, Hoon Gu Kim, Soo Jeong Kim, Jinny Park, Chul Won Choi, Young Rok Do, Inho Kim, Seonyang Park, Yeung Chul Mun, Seong Hyun Jeong, Min Kyoung Kim, Hyeon Gyu Yi, Myung Hee Chang, Su Youn Kim, Je Hwan Lee, Jun Ho Jang

Department of Internal Medicine

Research output: Contribution to journal › Article › peer-review

5 Scopus citations

Abstract

Introduction: Decitabine has shown clinical benefits in patients with intermediate (INT)-2 or high-risk myelodysplastic syndrome (MDS), determined according to the International Prognostic Scoring System (IPSS), but the benefits have not been well demonstrated in patients with lower-risk (IPSS low or INT-1) disease. Recently, it was proposed that the prognosis for patients with IPSS lower-risk disease is heterogeneous, with a substantial proportion of these patients having poor survival. Patients and Methods: This study included patients with IPSS lower-risk MDS from the DRAMA (An Observational Study for Dacogen Long-Term Treatment in Patients With Myelodysplastic Syndrome; NCT01400633) and DIVA (A Study for Dacogen Treatment in Patients With Myelodysplastic Syndrome; NCT01041846) studies, which were prospective observational studies on the efficacy and safety of decitabine treatment in patients with MDS. Using the Lower-Risk Prognostic Scoring System [LR-PSS], we classified IPSS lower-risk MDS. Patients in each LR-PSS category were divided according to overall response (OR) to decitabine treatment, and survival outcomes were compared. Results: One hundred sixteen patients were enrolled: LR-PSS category 1 (n = 12; 10.3%), category 2 (n = 56; 48.3%), and category 3 (n = 48; 41.4%). Survival outcomes differed among the 3 categories (P = .046). The overall survival according to OR showed a significant difference in total patients (P = .008) and category 3 patients (P = .003). We analyzed predictive factors for OR, but no variable was found to significantly affect OR. Conclusion: Decitabine treatment showed a survival benefit in the higher-risk group of IPSS lower-risk MDS patients who responded to treatment, and classification using the LR-PSS category was helpful for this subgroup, indicating that decitabine treatment might alter the natural course of disease in these patients. Decitabine showed a survival benefit in the higher-risk group (Lower-Risk Prognostic Scoring System [LR-PSS] category 3) of the International Prognostic Scoring System (IPSS) lower-risk (IPSS low or intermediate-1) myelodysplastic syndrome patients who responded to decitabine. Therefore, classification using the LR-PSS category was helpful for this subgroup, indicating that decitabine treatment might alter the natural course of disease in these patients.

Original language	English
Pages (from-to)	656-664
Number of pages	9
Journal	Clinical Lymphoma, Myeloma and Leukemia
Volume	19
Issue number	10
DOIs	https://doi.org/10.1016/j.clml.2019.06.003
State	Published - Oct 2019

Bibliographical note

Funding Information:
This study was supported by Janssen Korea Ltd. Dae Young Yu and Youngdoe Kim in Janssen Korea contributed to the medical writing and statistical analysis in this study. The investigators of this study, with the exception of the authors, were as follows: Chul Soo Kim, Department of Internal Medicine, Inha University Hospital, Inha University College of Medicine, Incheon, Korea; Young-Don Joo, Department of Hematology and Oncology, Haeundae Paik Hospital, Inje University College of Medicine, Busan, Korea; Yoo Hong Min, Division of Hematology, Department of Internal Medicine, Yonsei University College of Medicine, Severance Hospital, Seoul, Korea; Seung Hyun Nam, Department of Hematology-Oncology, VHS Medical Center, Seoul, Korea; Sung-Hyun Kim, Division of Hematology-Oncology, Department of Internal Medicine, Dong-A University College of Medicine, Busan, Korea; Eunkyung Park, Division of Hemato-Oncology, Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Korea; Ho Young Kim and Boram Han, Division of Hematology-Oncology, Department of Internal Medicine, Hallym University Medical Center, Hallym University College of Medicine, Anyang, Korea; Ki Hyeong Lee, Department of Internal Medicine, College of Medicine, Chungbuk National University, Cheongju, Korea; Byung Soo Kim, Division of Hematology/Oncology, Department of Internal Medicine, Korea University Medical Center, Seoul, Korea; Soo-Mee Bang, Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea; Ho-Jin Shin, Division of Hematology-Oncology, Department of Internal Medicine, Pusan National University Hospital, College of Medicine, Pusan National University, Busan, Korea; Won Sik Lee, Department of Internal Medicine, Inje University College of Medicine, Inje University Busan Paik Hospital, Busan, Korea; Hyun Woo Lee, Department of Hematology-Oncology, Ajou University School of Medicine, Suwon, Korea; Jeong-A Kim, Division of Hematology, Department of Internal Medicine, St. Vincent's Hospital, College of Medicine, Catholic University of Korea, Suwon, Korea; Sung-Hwa Bae and Hun Mo Ryoo, Department of Hematology and Oncology, Daegu Catholic University Hospital, Daegu, Korea; Chi-Young Park, Division of Hematology and Oncology, Department of Internal Medicine, Chosun University Hospital, Gwangju, Korea; Kyu Taek Lee, Division of Hematology and Oncology, Department of Internal Medicine, Soonchunhyang University Cheonan Hospital, Cheonan, Korea; Chu-Myong Seong, Department of Hematology and Oncology, School of Medicine, Ewha Womans University, Seoul, Korea; Yang Soo Kim, Department of Internal Medicine, Kosin University Gospel Hospital, Busan, Korea; Se Ryeon Lee, Department of Hematology/Oncology, Internal Medicine, Korea University Ansan Hospital, Ansan, Korea; Deog-Yeon Jo, Division of Hematology/Oncology, Department of Internal Medicine, Chungnam National University School of Medicine, Daejeon, Korea; Do Hyoung Lim, Department of Internal Medicine, Dankook University Hospital, Dankook University College of Medicine, Cheonan, Korea; Jae-Yong Kwak, Division of Hematology-Oncology, Chonbuk National University Medical School, Jeonju, Korea.

Funding Information:
This study was supported by Janssen Korea Ltd . Dae Young Yu and Youngdoe Kim in Janssen Korea contributed to the medical writing and statistical analysis in this study. The investigators of this study, with the exception of the authors, were as follows: Chul Soo Kim, Department of Internal Medicine, Inha University Hospital, Inha University College of Medicine, Incheon, Korea; Young-Don Joo, Department of Hematology and Oncology, Haeundae Paik Hospital, Inje University College of Medicine, Busan, Korea; Yoo Hong Min, Division of Hematology, Department of Internal Medicine, Yonsei University College of Medicine, Severance Hospital, Seoul, Korea; Seung Hyun Nam, Department of Hematology-Oncology, VHS Medical Center, Seoul, Korea; Sung-Hyun Kim, Division of Hematology-Oncology, Department of Internal Medicine, Dong-A University College of Medicine, Busan, Korea; Eunkyung Park, Division of Hemato-Oncology, Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Korea; Ho Young Kim and Boram Han, Division of Hematology-Oncology, Department of Internal Medicine, Hallym University Medical Center, Hallym University College of Medicine, Anyang, Korea; Ki Hyeong Lee, Department of Internal Medicine, College of Medicine, Chungbuk National University, Cheongju, Korea; Byung Soo Kim, Division of Hematology/Oncology, Department of Internal Medicine, Korea University Medical Center, Seoul, Korea; Soo-Mee Bang, Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea; Ho-Jin Shin, Division of Hematology-Oncology, Department of Internal Medicine, Pusan National University Hospital, College of Medicine, Pusan National University, Busan, Korea; Won Sik Lee, Department of Internal Medicine, Inje University College of Medicine, Inje University Busan Paik Hospital, Busan, Korea; Hyun Woo Lee, Department of Hematology-Oncology, Ajou University School of Medicine, Suwon, Korea; Jeong-A Kim, Division of Hematology, Department of Internal Medicine, St. Vincent’s Hospital, College of Medicine, Catholic University of Korea, Suwon, Korea; Sung-Hwa Bae and Hun Mo Ryoo, Department of Hematology and Oncology, Daegu Catholic University Hospital, Daegu, Korea; Chi-Young Park, Division of Hematology and Oncology, Department of Internal Medicine, Chosun University Hospital, Gwangju, Korea; Kyu Taek Lee, Division of Hematology and Oncology, Department of Internal Medicine, Soonchunhyang University Cheonan Hospital, Cheonan, Korea; Chu-Myong Seong, Department of Hematology and Oncology, School of Medicine, Ewha Womans University, Seoul, Korea; Yang Soo Kim, Department of Internal Medicine, Kosin University Gospel Hospital, Busan, Korea; Se Ryeon Lee, Department of Hematology/Oncology, Internal Medicine, Korea University Ansan Hospital, Ansan, Korea; Deog-Yeon Jo, Division of Hematology/Oncology, Department of Internal Medicine, Chungnam National University School of Medicine, Daejeon, Korea; Do Hyoung Lim, Department of Internal Medicine, Dankook University Hospital, Dankook University College of Medicine, Cheonan, Korea; Jae-Yong Kwak, Division of Hematology-Oncology, Chonbuk National University Medical School, Jeonju, Korea.

Publisher Copyright:
© 2019 Elsevier Inc.

Keywords

Decitabine
IPSS
LR-PSS
Lower-Risk Prognostic Scoring System
Myelodysplastic syndrome

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.1016/j.clml.2019.06.003

Cite this

Jung, K. S., Kim, Y. J., Kim, Y. K., Park, S. K., Kim, H. G., Kim, S. J., Park, J., Choi, C. W., Do, Y. R., Kim, I., Park, S., Mun, Y. C., Jeong, S. H., Kim, M. K., Yi, H. G., Chang, M. H., Kim, S. Y., Lee, J. H., & Jang, J. H. (2019). Clinical Outcomes of Decitabine Treatment for Patients With Lower-Risk Myelodysplastic Syndrome on the Basis of the International Prognostic Scoring System. Clinical Lymphoma, Myeloma and Leukemia, 19(10), 656-664. https://doi.org/10.1016/j.clml.2019.06.003

@article{b8b4262ef8664e06b8ddbbc0342c2281,

title = "Clinical Outcomes of Decitabine Treatment for Patients With Lower-Risk Myelodysplastic Syndrome on the Basis of the International Prognostic Scoring System",

abstract = "Introduction: Decitabine has shown clinical benefits in patients with intermediate (INT)-2 or high-risk myelodysplastic syndrome (MDS), determined according to the International Prognostic Scoring System (IPSS), but the benefits have not been well demonstrated in patients with lower-risk (IPSS low or INT-1) disease. Recently, it was proposed that the prognosis for patients with IPSS lower-risk disease is heterogeneous, with a substantial proportion of these patients having poor survival. Patients and Methods: This study included patients with IPSS lower-risk MDS from the DRAMA (An Observational Study for Dacogen Long-Term Treatment in Patients With Myelodysplastic Syndrome; NCT01400633) and DIVA (A Study for Dacogen Treatment in Patients With Myelodysplastic Syndrome; NCT01041846) studies, which were prospective observational studies on the efficacy and safety of decitabine treatment in patients with MDS. Using the Lower-Risk Prognostic Scoring System [LR-PSS], we classified IPSS lower-risk MDS. Patients in each LR-PSS category were divided according to overall response (OR) to decitabine treatment, and survival outcomes were compared. Results: One hundred sixteen patients were enrolled: LR-PSS category 1 (n = 12; 10.3%), category 2 (n = 56; 48.3%), and category 3 (n = 48; 41.4%). Survival outcomes differed among the 3 categories (P = .046). The overall survival according to OR showed a significant difference in total patients (P = .008) and category 3 patients (P = .003). We analyzed predictive factors for OR, but no variable was found to significantly affect OR. Conclusion: Decitabine treatment showed a survival benefit in the higher-risk group of IPSS lower-risk MDS patients who responded to treatment, and classification using the LR-PSS category was helpful for this subgroup, indicating that decitabine treatment might alter the natural course of disease in these patients. Decitabine showed a survival benefit in the higher-risk group (Lower-Risk Prognostic Scoring System [LR-PSS] category 3) of the International Prognostic Scoring System (IPSS) lower-risk (IPSS low or intermediate-1) myelodysplastic syndrome patients who responded to decitabine. Therefore, classification using the LR-PSS category was helpful for this subgroup, indicating that decitabine treatment might alter the natural course of disease in these patients.",

keywords = "Decitabine, IPSS, LR-PSS, Lower-Risk Prognostic Scoring System, Myelodysplastic syndrome",

author = "Jung, {Ki Sun} and Kim, {Yoo Jin} and Kim, {Yeo Kyeoung} and Park, {Sung Kyu} and Kim, {Hoon Gu} and Kim, {Soo Jeong} and Jinny Park and Choi, {Chul Won} and Do, {Young Rok} and Inho Kim and Seonyang Park and Mun, {Yeung Chul} and Jeong, {Seong Hyun} and Kim, {Min Kyoung} and Yi, {Hyeon Gyu} and Chang, {Myung Hee} and Kim, {Su Youn} and Lee, {Je Hwan} and Jang, {Jun Ho}",

note = "Funding Information: This study was supported by Janssen Korea Ltd. Dae Young Yu and Youngdoe Kim in Janssen Korea contributed to the medical writing and statistical analysis in this study. The investigators of this study, with the exception of the authors, were as follows: Chul Soo Kim, Department of Internal Medicine, Inha University Hospital, Inha University College of Medicine, Incheon, Korea; Young-Don Joo, Department of Hematology and Oncology, Haeundae Paik Hospital, Inje University College of Medicine, Busan, Korea; Yoo Hong Min, Division of Hematology, Department of Internal Medicine, Yonsei University College of Medicine, Severance Hospital, Seoul, Korea; Seung Hyun Nam, Department of Hematology-Oncology, VHS Medical Center, Seoul, Korea; Sung-Hyun Kim, Division of Hematology-Oncology, Department of Internal Medicine, Dong-A University College of Medicine, Busan, Korea; Eunkyung Park, Division of Hemato-Oncology, Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Korea; Ho Young Kim and Boram Han, Division of Hematology-Oncology, Department of Internal Medicine, Hallym University Medical Center, Hallym University College of Medicine, Anyang, Korea; Ki Hyeong Lee, Department of Internal Medicine, College of Medicine, Chungbuk National University, Cheongju, Korea; Byung Soo Kim, Division of Hematology/Oncology, Department of Internal Medicine, Korea University Medical Center, Seoul, Korea; Soo-Mee Bang, Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea; Ho-Jin Shin, Division of Hematology-Oncology, Department of Internal Medicine, Pusan National University Hospital, College of Medicine, Pusan National University, Busan, Korea; Won Sik Lee, Department of Internal Medicine, Inje University College of Medicine, Inje University Busan Paik Hospital, Busan, Korea; Hyun Woo Lee, Department of Hematology-Oncology, Ajou University School of Medicine, Suwon, Korea; Jeong-A Kim, Division of Hematology, Department of Internal Medicine, St. Vincent's Hospital, College of Medicine, Catholic University of Korea, Suwon, Korea; Sung-Hwa Bae and Hun Mo Ryoo, Department of Hematology and Oncology, Daegu Catholic University Hospital, Daegu, Korea; Chi-Young Park, Division of Hematology and Oncology, Department of Internal Medicine, Chosun University Hospital, Gwangju, Korea; Kyu Taek Lee, Division of Hematology and Oncology, Department of Internal Medicine, Soonchunhyang University Cheonan Hospital, Cheonan, Korea; Chu-Myong Seong, Department of Hematology and Oncology, School of Medicine, Ewha Womans University, Seoul, Korea; Yang Soo Kim, Department of Internal Medicine, Kosin University Gospel Hospital, Busan, Korea; Se Ryeon Lee, Department of Hematology/Oncology, Internal Medicine, Korea University Ansan Hospital, Ansan, Korea; Deog-Yeon Jo, Division of Hematology/Oncology, Department of Internal Medicine, Chungnam National University School of Medicine, Daejeon, Korea; Do Hyoung Lim, Department of Internal Medicine, Dankook University Hospital, Dankook University College of Medicine, Cheonan, Korea; Jae-Yong Kwak, Division of Hematology-Oncology, Chonbuk National University Medical School, Jeonju, Korea. Funding Information: This study was supported by Janssen Korea Ltd . Dae Young Yu and Youngdoe Kim in Janssen Korea contributed to the medical writing and statistical analysis in this study. The investigators of this study, with the exception of the authors, were as follows: Chul Soo Kim, Department of Internal Medicine, Inha University Hospital, Inha University College of Medicine, Incheon, Korea; Young-Don Joo, Department of Hematology and Oncology, Haeundae Paik Hospital, Inje University College of Medicine, Busan, Korea; Yoo Hong Min, Division of Hematology, Department of Internal Medicine, Yonsei University College of Medicine, Severance Hospital, Seoul, Korea; Seung Hyun Nam, Department of Hematology-Oncology, VHS Medical Center, Seoul, Korea; Sung-Hyun Kim, Division of Hematology-Oncology, Department of Internal Medicine, Dong-A University College of Medicine, Busan, Korea; Eunkyung Park, Division of Hemato-Oncology, Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Korea; Ho Young Kim and Boram Han, Division of Hematology-Oncology, Department of Internal Medicine, Hallym University Medical Center, Hallym University College of Medicine, Anyang, Korea; Ki Hyeong Lee, Department of Internal Medicine, College of Medicine, Chungbuk National University, Cheongju, Korea; Byung Soo Kim, Division of Hematology/Oncology, Department of Internal Medicine, Korea University Medical Center, Seoul, Korea; Soo-Mee Bang, Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea; Ho-Jin Shin, Division of Hematology-Oncology, Department of Internal Medicine, Pusan National University Hospital, College of Medicine, Pusan National University, Busan, Korea; Won Sik Lee, Department of Internal Medicine, Inje University College of Medicine, Inje University Busan Paik Hospital, Busan, Korea; Hyun Woo Lee, Department of Hematology-Oncology, Ajou University School of Medicine, Suwon, Korea; Jeong-A Kim, Division of Hematology, Department of Internal Medicine, St. Vincent{\textquoteright}s Hospital, College of Medicine, Catholic University of Korea, Suwon, Korea; Sung-Hwa Bae and Hun Mo Ryoo, Department of Hematology and Oncology, Daegu Catholic University Hospital, Daegu, Korea; Chi-Young Park, Division of Hematology and Oncology, Department of Internal Medicine, Chosun University Hospital, Gwangju, Korea; Kyu Taek Lee, Division of Hematology and Oncology, Department of Internal Medicine, Soonchunhyang University Cheonan Hospital, Cheonan, Korea; Chu-Myong Seong, Department of Hematology and Oncology, School of Medicine, Ewha Womans University, Seoul, Korea; Yang Soo Kim, Department of Internal Medicine, Kosin University Gospel Hospital, Busan, Korea; Se Ryeon Lee, Department of Hematology/Oncology, Internal Medicine, Korea University Ansan Hospital, Ansan, Korea; Deog-Yeon Jo, Division of Hematology/Oncology, Department of Internal Medicine, Chungnam National University School of Medicine, Daejeon, Korea; Do Hyoung Lim, Department of Internal Medicine, Dankook University Hospital, Dankook University College of Medicine, Cheonan, Korea; Jae-Yong Kwak, Division of Hematology-Oncology, Chonbuk National University Medical School, Jeonju, Korea. Publisher Copyright: {\textcopyright} 2019 Elsevier Inc.",

year = "2019",

month = oct,

doi = "10.1016/j.clml.2019.06.003",

language = "English",

volume = "19",

pages = "656--664",

journal = "Clinical Lymphoma, Myeloma and Leukemia",

issn = "2152-2650",

publisher = "Cancer Media Group",

number = "10",

}

Jung, KS, Kim, YJ, Kim, YK, Park, SK, Kim, HG, Kim, SJ, Park, J, Choi, CW, Do, YR, Kim, I, Park, S, Mun, YC, Jeong, SH, Kim, MK, Yi, HG, Chang, MH, Kim, SY, Lee, JH & Jang, JH 2019, 'Clinical Outcomes of Decitabine Treatment for Patients With Lower-Risk Myelodysplastic Syndrome on the Basis of the International Prognostic Scoring System', Clinical Lymphoma, Myeloma and Leukemia, vol. 19, no. 10, pp. 656-664. https://doi.org/10.1016/j.clml.2019.06.003

TY - JOUR

T1 - Clinical Outcomes of Decitabine Treatment for Patients With Lower-Risk Myelodysplastic Syndrome on the Basis of the International Prognostic Scoring System

AU - Jung, Ki Sun

AU - Kim, Yoo Jin

AU - Kim, Yeo Kyeoung

AU - Park, Sung Kyu

AU - Kim, Hoon Gu

AU - Kim, Soo Jeong

AU - Park, Jinny

AU - Choi, Chul Won

AU - Do, Young Rok

AU - Kim, Inho

AU - Park, Seonyang

AU - Mun, Yeung Chul

AU - Jeong, Seong Hyun

AU - Kim, Min Kyoung

AU - Yi, Hyeon Gyu

AU - Chang, Myung Hee

AU - Kim, Su Youn

AU - Lee, Je Hwan

AU - Jang, Jun Ho

N1 - Funding Information: This study was supported by Janssen Korea Ltd. Dae Young Yu and Youngdoe Kim in Janssen Korea contributed to the medical writing and statistical analysis in this study. The investigators of this study, with the exception of the authors, were as follows: Chul Soo Kim, Department of Internal Medicine, Inha University Hospital, Inha University College of Medicine, Incheon, Korea; Young-Don Joo, Department of Hematology and Oncology, Haeundae Paik Hospital, Inje University College of Medicine, Busan, Korea; Yoo Hong Min, Division of Hematology, Department of Internal Medicine, Yonsei University College of Medicine, Severance Hospital, Seoul, Korea; Seung Hyun Nam, Department of Hematology-Oncology, VHS Medical Center, Seoul, Korea; Sung-Hyun Kim, Division of Hematology-Oncology, Department of Internal Medicine, Dong-A University College of Medicine, Busan, Korea; Eunkyung Park, Division of Hemato-Oncology, Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Korea; Ho Young Kim and Boram Han, Division of Hematology-Oncology, Department of Internal Medicine, Hallym University Medical Center, Hallym University College of Medicine, Anyang, Korea; Ki Hyeong Lee, Department of Internal Medicine, College of Medicine, Chungbuk National University, Cheongju, Korea; Byung Soo Kim, Division of Hematology/Oncology, Department of Internal Medicine, Korea University Medical Center, Seoul, Korea; Soo-Mee Bang, Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea; Ho-Jin Shin, Division of Hematology-Oncology, Department of Internal Medicine, Pusan National University Hospital, College of Medicine, Pusan National University, Busan, Korea; Won Sik Lee, Department of Internal Medicine, Inje University College of Medicine, Inje University Busan Paik Hospital, Busan, Korea; Hyun Woo Lee, Department of Hematology-Oncology, Ajou University School of Medicine, Suwon, Korea; Jeong-A Kim, Division of Hematology, Department of Internal Medicine, St. Vincent's Hospital, College of Medicine, Catholic University of Korea, Suwon, Korea; Sung-Hwa Bae and Hun Mo Ryoo, Department of Hematology and Oncology, Daegu Catholic University Hospital, Daegu, Korea; Chi-Young Park, Division of Hematology and Oncology, Department of Internal Medicine, Chosun University Hospital, Gwangju, Korea; Kyu Taek Lee, Division of Hematology and Oncology, Department of Internal Medicine, Soonchunhyang University Cheonan Hospital, Cheonan, Korea; Chu-Myong Seong, Department of Hematology and Oncology, School of Medicine, Ewha Womans University, Seoul, Korea; Yang Soo Kim, Department of Internal Medicine, Kosin University Gospel Hospital, Busan, Korea; Se Ryeon Lee, Department of Hematology/Oncology, Internal Medicine, Korea University Ansan Hospital, Ansan, Korea; Deog-Yeon Jo, Division of Hematology/Oncology, Department of Internal Medicine, Chungnam National University School of Medicine, Daejeon, Korea; Do Hyoung Lim, Department of Internal Medicine, Dankook University Hospital, Dankook University College of Medicine, Cheonan, Korea; Jae-Yong Kwak, Division of Hematology-Oncology, Chonbuk National University Medical School, Jeonju, Korea. Funding Information: This study was supported by Janssen Korea Ltd . Dae Young Yu and Youngdoe Kim in Janssen Korea contributed to the medical writing and statistical analysis in this study. The investigators of this study, with the exception of the authors, were as follows: Chul Soo Kim, Department of Internal Medicine, Inha University Hospital, Inha University College of Medicine, Incheon, Korea; Young-Don Joo, Department of Hematology and Oncology, Haeundae Paik Hospital, Inje University College of Medicine, Busan, Korea; Yoo Hong Min, Division of Hematology, Department of Internal Medicine, Yonsei University College of Medicine, Severance Hospital, Seoul, Korea; Seung Hyun Nam, Department of Hematology-Oncology, VHS Medical Center, Seoul, Korea; Sung-Hyun Kim, Division of Hematology-Oncology, Department of Internal Medicine, Dong-A University College of Medicine, Busan, Korea; Eunkyung Park, Division of Hemato-Oncology, Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Korea; Ho Young Kim and Boram Han, Division of Hematology-Oncology, Department of Internal Medicine, Hallym University Medical Center, Hallym University College of Medicine, Anyang, Korea; Ki Hyeong Lee, Department of Internal Medicine, College of Medicine, Chungbuk National University, Cheongju, Korea; Byung Soo Kim, Division of Hematology/Oncology, Department of Internal Medicine, Korea University Medical Center, Seoul, Korea; Soo-Mee Bang, Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea; Ho-Jin Shin, Division of Hematology-Oncology, Department of Internal Medicine, Pusan National University Hospital, College of Medicine, Pusan National University, Busan, Korea; Won Sik Lee, Department of Internal Medicine, Inje University College of Medicine, Inje University Busan Paik Hospital, Busan, Korea; Hyun Woo Lee, Department of Hematology-Oncology, Ajou University School of Medicine, Suwon, Korea; Jeong-A Kim, Division of Hematology, Department of Internal Medicine, St. Vincent’s Hospital, College of Medicine, Catholic University of Korea, Suwon, Korea; Sung-Hwa Bae and Hun Mo Ryoo, Department of Hematology and Oncology, Daegu Catholic University Hospital, Daegu, Korea; Chi-Young Park, Division of Hematology and Oncology, Department of Internal Medicine, Chosun University Hospital, Gwangju, Korea; Kyu Taek Lee, Division of Hematology and Oncology, Department of Internal Medicine, Soonchunhyang University Cheonan Hospital, Cheonan, Korea; Chu-Myong Seong, Department of Hematology and Oncology, School of Medicine, Ewha Womans University, Seoul, Korea; Yang Soo Kim, Department of Internal Medicine, Kosin University Gospel Hospital, Busan, Korea; Se Ryeon Lee, Department of Hematology/Oncology, Internal Medicine, Korea University Ansan Hospital, Ansan, Korea; Deog-Yeon Jo, Division of Hematology/Oncology, Department of Internal Medicine, Chungnam National University School of Medicine, Daejeon, Korea; Do Hyoung Lim, Department of Internal Medicine, Dankook University Hospital, Dankook University College of Medicine, Cheonan, Korea; Jae-Yong Kwak, Division of Hematology-Oncology, Chonbuk National University Medical School, Jeonju, Korea. Publisher Copyright: © 2019 Elsevier Inc.

PY - 2019/10

Y1 - 2019/10

N2 - Introduction: Decitabine has shown clinical benefits in patients with intermediate (INT)-2 or high-risk myelodysplastic syndrome (MDS), determined according to the International Prognostic Scoring System (IPSS), but the benefits have not been well demonstrated in patients with lower-risk (IPSS low or INT-1) disease. Recently, it was proposed that the prognosis for patients with IPSS lower-risk disease is heterogeneous, with a substantial proportion of these patients having poor survival. Patients and Methods: This study included patients with IPSS lower-risk MDS from the DRAMA (An Observational Study for Dacogen Long-Term Treatment in Patients With Myelodysplastic Syndrome; NCT01400633) and DIVA (A Study for Dacogen Treatment in Patients With Myelodysplastic Syndrome; NCT01041846) studies, which were prospective observational studies on the efficacy and safety of decitabine treatment in patients with MDS. Using the Lower-Risk Prognostic Scoring System [LR-PSS], we classified IPSS lower-risk MDS. Patients in each LR-PSS category were divided according to overall response (OR) to decitabine treatment, and survival outcomes were compared. Results: One hundred sixteen patients were enrolled: LR-PSS category 1 (n = 12; 10.3%), category 2 (n = 56; 48.3%), and category 3 (n = 48; 41.4%). Survival outcomes differed among the 3 categories (P = .046). The overall survival according to OR showed a significant difference in total patients (P = .008) and category 3 patients (P = .003). We analyzed predictive factors for OR, but no variable was found to significantly affect OR. Conclusion: Decitabine treatment showed a survival benefit in the higher-risk group of IPSS lower-risk MDS patients who responded to treatment, and classification using the LR-PSS category was helpful for this subgroup, indicating that decitabine treatment might alter the natural course of disease in these patients. Decitabine showed a survival benefit in the higher-risk group (Lower-Risk Prognostic Scoring System [LR-PSS] category 3) of the International Prognostic Scoring System (IPSS) lower-risk (IPSS low or intermediate-1) myelodysplastic syndrome patients who responded to decitabine. Therefore, classification using the LR-PSS category was helpful for this subgroup, indicating that decitabine treatment might alter the natural course of disease in these patients.

AB - Introduction: Decitabine has shown clinical benefits in patients with intermediate (INT)-2 or high-risk myelodysplastic syndrome (MDS), determined according to the International Prognostic Scoring System (IPSS), but the benefits have not been well demonstrated in patients with lower-risk (IPSS low or INT-1) disease. Recently, it was proposed that the prognosis for patients with IPSS lower-risk disease is heterogeneous, with a substantial proportion of these patients having poor survival. Patients and Methods: This study included patients with IPSS lower-risk MDS from the DRAMA (An Observational Study for Dacogen Long-Term Treatment in Patients With Myelodysplastic Syndrome; NCT01400633) and DIVA (A Study for Dacogen Treatment in Patients With Myelodysplastic Syndrome; NCT01041846) studies, which were prospective observational studies on the efficacy and safety of decitabine treatment in patients with MDS. Using the Lower-Risk Prognostic Scoring System [LR-PSS], we classified IPSS lower-risk MDS. Patients in each LR-PSS category were divided according to overall response (OR) to decitabine treatment, and survival outcomes were compared. Results: One hundred sixteen patients were enrolled: LR-PSS category 1 (n = 12; 10.3%), category 2 (n = 56; 48.3%), and category 3 (n = 48; 41.4%). Survival outcomes differed among the 3 categories (P = .046). The overall survival according to OR showed a significant difference in total patients (P = .008) and category 3 patients (P = .003). We analyzed predictive factors for OR, but no variable was found to significantly affect OR. Conclusion: Decitabine treatment showed a survival benefit in the higher-risk group of IPSS lower-risk MDS patients who responded to treatment, and classification using the LR-PSS category was helpful for this subgroup, indicating that decitabine treatment might alter the natural course of disease in these patients. Decitabine showed a survival benefit in the higher-risk group (Lower-Risk Prognostic Scoring System [LR-PSS] category 3) of the International Prognostic Scoring System (IPSS) lower-risk (IPSS low or intermediate-1) myelodysplastic syndrome patients who responded to decitabine. Therefore, classification using the LR-PSS category was helpful for this subgroup, indicating that decitabine treatment might alter the natural course of disease in these patients.

KW - Decitabine

KW - IPSS

KW - LR-PSS

KW - Lower-Risk Prognostic Scoring System

KW - Myelodysplastic syndrome

UR - http://www.scopus.com/inward/record.url?scp=85069820918&partnerID=8YFLogxK

U2 - 10.1016/j.clml.2019.06.003

DO - 10.1016/j.clml.2019.06.003

M3 - Article

C2 - 31375393

AN - SCOPUS:85069820918

SN - 2152-2650

VL - 19

SP - 656

EP - 664

JO - Clinical Lymphoma, Myeloma and Leukemia

JF - Clinical Lymphoma, Myeloma and Leukemia

IS - 10

ER -

Clinical Outcomes of Decitabine Treatment for Patients With Lower-Risk Myelodysplastic Syndrome on the Basis of the International Prognostic Scoring System

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