|Decitabine for Treatment of Myelodysplastic Syndromes in Chinese Patients: An Open-Label, Phase-3b Study|
|Wu, Depei1; Du, Xin2; Jin, Jie3; Xiao, Zhijian4,5; Shen, Zhixiang6; Shao, Zonghong7; Li, Xiao8; Huang, Xiaojun9; Liu, Ting10; Yu, Li11; Li, Jianyong12; Chen, Baoan13; He, Guangsheng1; Cai, Zhen3; Liang, Hongchuang14; Li, Jigang14; Ruan, Changgeng1|
|关键词||Chinese population Decitabine Hematology Myelodysplastic syndrome (MDS) Oncology Phase 3b|
|刊名||ADVANCES IN THERAPY|
|WOS标题词||Science & Technology|
|类目[WOS]||Medicine, Research & Experimental ; Pharmacology & Pharmacy|
|研究领域[WOS]||Research & Experimental Medicine ; Pharmacology & Pharmacy|
|关键词[WOS]||CHRONIC MYELOGENOUS LEUKEMIA ; INTERNATIONAL WORKING GROUP ; ACUTE MYELOID-LEUKEMIA ; RESPONSE CRITERIA ; 5-AZA-2&prime ; -DEOXYCYTIDINE DECITABINE ; HYPOMETHYLATING AGENT ; SCORING SYSTEMS ; MULTICENTER ; MANAGEMENT ; DIAGNOSIS|
The objective of this study was to evaluate the efficacy and safety of decitabine in Chinese patients with myelodysplastic syndrome (MDS).
Patients (a parts per thousand yen18 years) who had a de novo or secondary MDS diagnosis according to French-American-British classification and an International Prognostic Scoring System score a parts per thousand yen0.5 were enrolled and randomized (1:1) to one of two decitabine regimens: 3-day treatment (3-h intravenous infusion of 15 mg/m(2) given every 8 h for three consecutive days/cycle/6 weeks) or 5-day treatment (1-h intravenous infusion of 20 mg/m(2) once daily on days 1-5/cycle/4 weeks). After a minimum of 30 patients were assigned to 3-day schedule, the remaining were assigned to the 5-day schedule. The primary efficacy endpoint was the overall response rate (ORR). Secondary outcome measures included hematologic improvement (HI), cytogenetic response rate, the time to acute myeloid leukemia (AML) progression, and overall survival (OS).
In total, 132 of 135 enrolled patients (3-day treatment, n = 36; 5-day treatment, n = 99) discontinued treatment (major reasons included patient withdrawal/lack of efficacy, n = 48; adverse events, n = 23; and disease progression, n = 22). During the study, 35 of 132 (26.5%) patients from the intent-to-treat (ITT) group achieved significant (P < 0.001) ORR [3-day group (n = 10, 29.4%), P = 0.003; 5-day group (n = 25, 25.5%), P < 0.001]. The HI rate was similar between the 3-day (47.1%) and 5-day groups (48.0%). Cytogenetic response was achieved in 20 of the 30 (66.7%) patients who had a baseline cytogenetic abnormality. Fifty-three (40.2%) AML transformations or deaths occurred and the median AML-free survival time was 23.8 months for all patients from the ITT set; 24-month OS rate was 48.9%. Adverse events of myelosuppression-related disorders (85.6%) and infections (43.2%) were commonly reported.
Decitabine treatment was efficacious in Chinese patients with MDS with its safety profile comparable to the global studies of decitabine conducted to date.
Xian-Janssen Pharmaceutical Ltd. China (a company of Johnson & Johnson).
ClinicalTrials.gov identifier, NCT01751867.
|资助机构||Xian-Janssen Pharmaceutical Ltd. China ; Xian-Janssen Pharmaceutical Ltd. China (a company of Johnson Johnson)|
|作者单位||1.Guangdong Gen Hosp, Guangzhou, Guangdong, Peoples R China|
2.Blood Dis Hosp, Tianjin, Peoples R China
3.Tianjin Med Univ, Gen Hosp, Tianjin, Peoples R China
4.Shanghai 6th Peoples Hosp, Shanghai, Peoples R China
5.Peking Univ, Peoples Hosp, Beijing 100871, Peoples R China
6.Sichuan Univ, West China Hosp, Chengdu 610064, Peoples R China
7.Xian Janssen Pharmaceut Ltd, Beijing, Peoples R China
8.Soochow Univ, Affiliated Hosp 1, Suzhou, Jiangsu, Peoples R China
9.Zhejiang Univ, Coll Med, Affiliated Hosp 1, Hangzhou 310003, Zhejiang, Peoples R China
10.Chinese Acad Med Sci, Inst Hematol, Tianjin, Peoples R China
11.Shanghai Jiao Tong Univ, Coll Med, Affiliated Ruijin Hosp, Shanghai 200030, Peoples R China
12.Chinese Peoples Liberat Army Gen Hosp, Beijing, Peoples R China
13.Nanjing Med Univ, Jiangsu Prov Hosp, Affiliated Hosp 1, Nanjing, Jiangsu, Peoples R China
14.Southeast Univ, Zhongda Hosp, Nanjing, Jiangsu, Peoples R China
|Wu, Depei,Du, Xin,Jin, Jie,et al. Decitabine for Treatment of Myelodysplastic Syndromes in Chinese Patients: An Open-Label, Phase-3b Study[J]. ADVANCES IN THERAPY,2015,32(11):1140-1159.|
|APA||Wu, Depei.,Du, Xin.,Jin, Jie.,Xiao, Zhijian.,Shen, Zhixiang.,...&Ruan, Changgeng.(2015).Decitabine for Treatment of Myelodysplastic Syndromes in Chinese Patients: An Open-Label, Phase-3b Study.ADVANCES IN THERAPY,32(11),1140-1159.|
|MLA||Wu, Depei,et al."Decitabine for Treatment of Myelodysplastic Syndromes in Chinese Patients: An Open-Label, Phase-3b Study".ADVANCES IN THERAPY 32.11(2015):1140-1159.|