Author:
Cao Xuanqi,Li Zheng,Zhang Yanming,Cui Qingya,Dai Haiping,Ma Yunju,Li Mengyun,Chen Sifan,Yin Jia,Cui Wei,Chen Jia,Sun Aining,Qiu Huiying,Chen Suning,Zhu Xiaming,Andersson Borje S.,Wu Depei,Tang Xiaowen
Abstract
AbstractThis study aimed to evaluate the efficacy and safety of chidamide (Chi) combined with a modified Busulfan-Cyclophosphamide (mBuCy) conditioning regimen for T-cell acute lymphoblastic leukemia/lymphoma (T-ALL/LBL) patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT). Twenty-two patients received chidamide combined with mBuCy conditioning regimen (Chi group). A matched-pair control (CON) group of 44 patients (matched 1:2) received mBuCy only in the same period. The leukemia-free survival (LFS), overall survival (OS), cumulative incidence of relapse (CIR), and non-relapse-related mortality (NRM) were evaluated. Patients in the Chi group were associated with lower 2-year CIR (19.0 vs. 41.4%, P = 0.030), better 2-year LFS (76.1 vs. 48.1%, P = 0.014), and had no significant difference in 2-year OS (80.5 vs. 66.4%, P = 0.088). Patients with minimal residual disease (MRD) positive before HSCT in the Chi group exhibited an advantage in 2-year LFS and a trend towards better 2-year OS (75.0 vs. 10.2%, P = 0.048; 75.0 vs. 11.4%, P = 0.060, respectively). Multivariable analysis showed that the chidamide intensified regimen was independently associated with better LFS (HR 0.23; 95%CI, 0.08–0.63; P = 0.004), and showed no significant impact with OS for all patients (HR 0.34, 95%CI, 0.11–1.07; P = 0.064). The cumulative incidence rates of grade II-IV aGVHD were similar (36.4 vs. 38.6%, P = 0.858). 20 patients in Chi group evinced an elevation in γ-glutamyltransferase, as compared to the mBuCy group (90.9 vs. 65.9%, P = 0.029). No transplantation-related mortality was documented within the first 100 days after transplantation. The results demonstrate that the chidamide intensified regimen may be an effective and acceptable safety option for T-ALL/LBL undergoing allo-HSCT, and further validation is needed.
Funder
the Priority Academic Program Development of Jiangsu Higher Education Institutions
National Natural Science Foundation of China
Frontier Clinical Technical Project of Suzhou Science and Technology plan
Bethune Charitable Foundation
Suzhou diagnosis and treatment project of Clinical Key Diseases
China International Medical Foundation
Boxi clinical research project of The First Affiliated Hospital of Soochow University
Publisher
Springer Science and Business Media LLC