Dasatinib combined with multi-agent chemotherapy regimen in newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia: a prospective study from a single center
10.3760/cma.j.issn.0253-2727.2021.02.004
- VernacularTitle:达沙替尼联合多药化疗方案治疗成人初诊Ph +急性淋巴细胞白血病：一项单中心前瞻性研究
- Author:
Guangji ZHANG
1
;
Xiaoyuan GONG
;
Shaowei QIU
;
Chunlin ZHOU
;
Kaiqi LIU
;
Dong LIN
;
Bingcheng LIU
;
Hui WEI
;
Shuning WEI
;
Yan LI
;
Runxia GU
;
Benfa GONG
;
Yuntao LIU
;
Qiuyun FANG
;
Yingchang MI
;
Ying WANG
;
Jianxiang WANG
Author Information
1. 中国医学科学院血液病医院（中国医学科学院血液学研究所），实验血液学国家重点实验室，国家血液系统疾病临床医学研究中心，天津 300020
- Keywords:
Philadelphia chromosome;
Leukemia, lymphoblastic, acute;
Dasatinib
- From:
Chinese Journal of Hematology
2021;42(2):109-115
- CountryChina
- Language:Chinese
-
Abstract:
Objective:This study evaluates the efficacy and safety of dasatinib combined with a multi-agent chemotherapy regimen of Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph + ALL) patients. Methods:This prospective, single-arm, and open clinical study enrolled 30 adult Ph + ALL patients who were newly diagnosed and treated from January 2016 to April 2018 in the center of this study. Standard induction chemotherapy was given for 4 weeks. However, dasatinib (100 mg/d) was continuously administered from day 8 until the end of the whole therapy in the induction therapy. Patients who are available for allogeneic or autologous stem cell transplantation (SCT) received transplantation when the disease was evaluated as complete remission. Results:All 30 patients achieved hematological complete remission (HCR) after the induction chemotherapy, and 70.0% (21/30) of them achieved the accumulated molecular complete remission (MCR) . The patients were followed up with a median follow-up time of 37.8 months (32.0-46.6) . The 3 year overall survival (OS) and 3 year hematological relapse-free survival (HRFS) were 68.1% and 61.6%, respectively. Moreover, 63.3% and 43.3% of the patients achieved molecular major remission and MCR, respectively. Consequently, 60.0% of the patients achieved MCR until 6 months. The patients who achieved MCR within 6 months had superior OS ( P=0.004) , HRFS ( P=0.049) , and event-free survival (EFS; P=0.001) . Fifteen patients (50.0%) received SCT at the first HCR. However, HRFS ( P=0.030) and EFS ( P=0.010) in the SCT group were better than those in the chemotherapy group. Conclusions:The regimen of dasatinib combined with a multi-agent chemotherapy was proven safe and effective in the treatment of newly diagnosed adult Ph + ALL patients. Clinical trial registration:ClinicalTrials.gov, NCT02523976.
