Chidamide, decitabine, cytarabine, aclarubicin, and granulocyte colony-stimulating factor (CDCAG) in patients with relap
- PDF / 1,353,641 Bytes
- 11 Pages / 595.276 x 790.866 pts Page_size
- 35 Downloads / 164 Views
RESEARCH
Open Access
Chidamide, decitabine, cytarabine, aclarubicin, and granulocyte colonystimulating factor (CDCAG) in patients with relapsed/refractory acute myeloid leukemia: a single-arm, phase 1/2 study Lixin Wang1,2†, Jianmin Luo3†, Guofeng Chen4,5,6†, Meiyun Fang7, Xudong Wei8, Yinghua Li9, Zhuogang Liu10, Yin Zhang11, Sujun Gao12, Jianliang Shen2, Xin Wang13, Xiaoning Gao6, Wei Zhou5, Yigai Ma14, Hui Liu15, Xinquan Li16, Linhua Yang17, Kai Sun11 and Li Yu1,6*
Abstract 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. (Continued on next page)
* Correspondence: [email protected] † Lixin Wang, Jianmin Luo and Guofeng Chen contributed equally to this work. 1 Department of Hematology-Oncology, International Cancer Center, Shenzhen University General Hospital, Shenzhen University Health Science Center, Shenzhen, China 6 Department of Hematology, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statut
Data Loading...
