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3615 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

Program: Oral and Poster Abstracts
Session: 632. Chronic Myeloid Leukemia: Clinical and Epidemiological: Poster III
Hematology Disease Topics & Pathways:
Acquired Marrow Failure Syndromes, Clinical Research, Clinically Relevant, Diseases, Myeloid Malignancies
Monday, December 13, 2021, 6:00 PM-8:00 PM

Dan Yu1*, Zhuangzhi Yang2*, Hui Cheng1*, Rui Jiang3*, Jingming Guo4*, Chucheng Wan5*, Jun Qin6*, Youshan Zhang7*, Guolin Yuan8*, Daozi Jiang9*, Chun Zhang10*, Fang Liu10*, Min Zhang10*, Shiming Chen11*, Caixia Liang7*, Jing Zou10*, Zhiwei Wu3*, Xiuping Zou2*, Danlei Han4*, Xu Chen5*, Li Wang6*, Tingting Lv8*, Xiaolong Tian8*, Yanping Xie3*, Hongyu An11*, Li Yan9*, Yicheng Zhang12 and Weiming Li10*

1Wuhan No.1 Hospital, Wuhan, China
2Suizhou Central Hospital corresponding, Suizhou, China
3Jingmen No.1 people's hospital, Jingmen, China
4Yichang Central People's hospital, Yichang, China
5Shiyan Taihe hospital, Shiyan, China
6Shiyan people's hospital, Shiyan, China
7Jingzhou No.1 People's hospital, Jingzhou, China
8Department of Hematology, Xiangyang Central Hospital,Affiliated Hospital of Hubei, Xiangyang, China
9Department of Hematology, Wuhan University Renmin Hospital, Wuhan University, Wuhan, China
10Union Hospital,Tongji Medical College,Huazhong University of Science and Technology, Wuhan, China
11Huangshi central hospital, Huangshi, China
12Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology, Wuhan, China

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.

Disclosures: No relevant conflicts of interest to declare.

*signifies non-member of ASH