Chidamide, decitabine, cytarabine, aclarubicin, and granulocyte colony-stimulating factor (CDCAG) in patients with relapsed/refractory acute myeloid leukemia: a single-arm, phase 1/2 study
单位：[1]Department of Hematology-Oncology, International Cancer Center,Shenzhen University General Hospital, Shenzhen University Health ScienceCenter, Shenzhen, China深圳大学总医院深圳市康宁医院深圳医学信息中心[2]Department of Hematology, The Sixth MedicalCenter, Chinese General Hospital of PLA, Beijing, China[3]Department ofHematology, The Second Hospital of Hebei Medical University, Shijiazhuang,China[4]Department of Endoscopy, Tianjin Medical University Cancer Instituteand Hospital, National Clinical Research Center for Cancer, Tianjin’s ClinicalResearch Center for Cancer, Key Laboratory of Cancer Prevention andTherapy, Tianjin, China[5]School of Medicine, Nankai University, Tianjin, China[6]Department of Hematology, Chinese PLA General Hospital, 28 Fuxing Road,Beijing 100853, China[7]Department of Hematology, The First AffiliatedHospital of Dalian Medical University, Dalian, China[8]Department ofHematology, The Affiliated Cancer Hospital of Zhengzhou University, HenanCancer Hospital, Zhengzhou, China河南省肿瘤医院[9]Department of Hematology, The FirstAffiliated Hospital of Harbin Medical University, Harbin, China[10]Departmentof Hematology, Shengjing Hospital of China Medical University, Shenyang,China中国医科大学附属盛京医院[11]Department of Hematology, Henan Provincial People’s Hospital,Zhengzhou, China[12]Department of Hematology, The First Hospital, JilinUniversity, Changchun, China[13]Department of Hematology, ShandongProvincial Hospital Affiliated to Shandong University, Jinan, China[14]Department of Hematology, ChinaJapan Friendship Hospital, Beijing, China[15]Department of Hematology, Beijing Hospital, National Center ofGerontology, Beijing, China[16]Department of Hematology, Beijing TsinghuaChanggung Hospital, Tsinghua University, Beijing, China[17]Department ofHematology, The Second Hospital of Shanxi Medical University, Taiyuan,China
Background Epigenetic mechanisms play an important role in the chemoresistance of acute myeloid leukemia (AML). The clinical response to epigenetic modifier-based chemotherapy in patients with relapsed/refractory AML (r/r AML) is unclear. This multicenter clinical trial evaluated the safety and efficacy of epigenetic modifiers (chidamide and decitabine) in combination with aclarubicin, cytarabine, and granulocyte colony-stimulating factor (G-CSF) in patients with r/r AML. Results Adult patients with r/r AML were treated with chidamide, decitabine, cytarabine, aclarubicin, and G-CSF (CDCAG). The primary measures were overall response (OR), overall survival (OS), and safety. Next-generation sequencing was performed to analyze the correlation between gene mutations and response. A total of 93 patients with r/r AML were enrolled. Overall, 24 patients had a complete remission (CR) and 19 patients achieved CR with incomplete blood count recovery (CRi). The overall response rate (ORR) was 46.2%. The overall survival of these 43 patients who achieved CR/CRi was significantly longer than that of patients who failed to achieve remission (563 vs 152 days,P< 0.0001). Of the patients with mutations in epigenetic and transcription factor-related genes, but without internal tandem duplications in FMS-like tyrosine kinase3 (FLT3-ITDs), 55.6% achieved CR/CRi, whereas the ORR was 28.2% for patients with mutations in other genes. Conclusions The CDCAG regimen was well tolerated and effective in r/r AML. Patients with epigenetic and transcription factor-related gene mutations, but withoutFLT3-ITD mutations, may benefit from this regimen.
基金：
National Natural Science Foundation of ChinaNational Natural Science Foundation of China (NSFC) [81670162, 81470010, 81350004]
第一作者单位：[1]Department of Hematology-Oncology, International Cancer Center,Shenzhen University General Hospital, Shenzhen University Health ScienceCenter, Shenzhen, China[2]Department of Hematology, The Sixth MedicalCenter, Chinese General Hospital of PLA, Beijing, China
共同第一作者：
通讯作者：
通讯机构：[1]Department of Hematology-Oncology, International Cancer Center,Shenzhen University General Hospital, Shenzhen University Health ScienceCenter, Shenzhen, China[6]Department of Hematology, Chinese PLA General Hospital, 28 Fuxing Road,Beijing 100853, China
推荐引用方式(GB/T 7714)：
Wang Lixin,Luo Jianmin,Chen Guofeng,et al.Chidamide, decitabine, cytarabine, aclarubicin, and granulocyte colony-stimulating factor (CDCAG) in patients with relapsed/refractory acute myeloid leukemia: a single-arm, phase 1/2 study[J].CLINICAL EPIGENETICS.2020,12(1):doi:10.1186/s13148-020-00923-4.
APA：
Wang Lixin,Luo Jianmin,Chen Guofeng,Fang Meiyun,Wei Xudong...&Yu Li.(2020).Chidamide, decitabine, cytarabine, aclarubicin, and granulocyte colony-stimulating factor (CDCAG) in patients with relapsed/refractory acute myeloid leukemia: a single-arm, phase 1/2 study.CLINICAL EPIGENETICS,12,(1)
MLA：
Wang Lixin,et al."Chidamide, decitabine, cytarabine, aclarubicin, and granulocyte colony-stimulating factor (CDCAG) in patients with relapsed/refractory acute myeloid leukemia: a single-arm, phase 1/2 study".CLINICAL EPIGENETICS 12..1(2020)
