The Comparison of Dasatinib 70 Mg/Day to 100 Mg/Day in Newly Diagnosed Patients with Chronic Myeloid Leukemia in Chronic Phase (CML-CP): A Multicenter, Prospective, Randomized Controlled Study

• Published in: Blood 2021-11, Vol.138 (Supplement 1), p.3615-3615
• Main Authors: Yu, Dan, Yang, Zhuangzhi, Cheng, Hui, Jiang, Rui, Guo, Jingming, Wan, Chucheng, Qin, Jun, Zhang, Youshan, Yuan, Guolin, Jiang, Daozi, Zhang, Chun, Liu, Fang, Zhang, Min, Chen, Shiming, Liang, Caixia, Zou, Jing, Wu, Zhiwei, Zou, Xiuping, Han, Danlei, Chen, Xu, Wang, Li, Lv, Tingting, Tian, Xiaolong, Xie, Yanping, An, Hongyu, Yan, Li, Zhang, Yicheng, Li, Weiming
• Format: Article
• Language: English
• ISSN: 0006-4971; 1528-0020
• DOI: 10.1182/blood-2021-148349

Background: The purpose of this study is to compare efficacy and safety of patients with newly diagnosed chronic myeloid leukemia in chronic phase (CML-CP) treated with frontline dasatinib 70 mg/day with those who received standard-dose dasatinib 100 mg/day. Method: From July 2019 to July 2021, 81 patients with newly diagnosed CML-CP were enrolled across 11 centers. All of the patients were randomly treated with dasatinib 70 mg/day (N=43) or standard-dose dasatinib 100 mg/day (N=38). Results: Among 81 enrolled patients, 16 patients were off study at different times for different reasons.All patients achieved hematological remission after 3 months of treatment, and the best response rates were 84.00% (21/25) and 88.89% (24/27) for 70mg/d and 100mg/d groups (P>0.05).At 6 months, the best response, complete cytogenetic response (CCyR) and major molecular response (MMR) rate were 94.44% vs 92.86% (P > 0.05), 94.44% vs 92.86% (P > 0.05) and 55.56% vs 71.43% (P > 0.05), respectively.At 9 months, the rates of CCyR and MMR were 90.91% vs 88.89% (P > 0.05) and 66.67% vs 72.73% (P > 0.05);CCyR and MMR by 12 months, respectively, were 90.91% vs 100.00% (P > 0.05), 81.82% vs 80.00% (P > 0.05).The adverse events (AEs) of the two groups were mild, and there was no significant difference (P > 0.05).The most common grade ≥3 hematological AEs in 70 mg/d group were leukopenia (1/43), neutropenia (1/43) and anemia (2/43), and In 100mg/d group were leukopenia (4/38), neutropenia (6/38), anemia (3/38) and thrombocytopenia (3/38). Conclusions: Our study suggests that patients with newly diagnosed CML-CP treated with dasatinib 70 mg/day or 100 mg/day, there is no significant difference in efficacy and safety. Decreasing the dose of dasatinib can ensure the efficacy of patients, while reducing the economic burden of patients and increasing patient compliance. No relevant conflicts of interest to declare.