Department of Hematology, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China.
Department of Hematology, Shenzhen Second People's Hospital, The First Affiliated Hospital of Shenzhen University, Shenzhen, China.
Clin Lymphoma Myeloma Leuk. 2022 Sep;22(9):e867-e873. doi: 10.1016/j.clml.2022.05.002. Epub 2022 May 21.
Brand-name dasatinib was approved for newly diagnosed chronic myeloid leukemia-chronic phase (CML-CP) patients due to its deeper and faster molecular response than imatinib. Generics, as the alternative, low-cost forms, are much in demand. This study aimed to evaluate the efficacy and safety of generic dasatinib (Yinishu) as a first-line treatment in CML-CP.
This was a prospective, multicenter, single-arm study from May 2016 to October 2018 with a 2-year follow-up analysis. All patients were given 100 mg/d (initial dose) of the generic dasatinib once a day. The primary endpoint was the major molecular response (MMR) calculated based on the BCR-ABL1 gene mutation rate of ≤ .1% at 12 months.
Among 55 patients in CP observed for at least 3 months, 80.4% achieved MMR at 12 months. The cumulative MR4.5 was 58.2% by 24 months. Responses occurred rapidly, with 69.1% of patients achieving complete cytogenetic response (CCyR) by 3 months and 70.9% achieving CCyR by 6 months. The estimated 2-year PFS and OS were both 96%, with a median follow-up time of 24 months. Grade 3 neutropenia occurred in 8.5% of patients, and thrombocytopenia occurred in 11.9% of patients. Nonhematologic toxicity was usually mild and manageable. Pleural effusion occurred in 20.3% of patients, and only 1 patient (1.7%) had a grade 3 pleural effusion. No grade 4 adverse events were observed.
Generic dasatinib is an effective option for newly diagnosed CML-CP patients, producing an MMR early in a greater number of patients during their therapy.
达沙替尼原研药因其较伊马替尼更深和更快的分子反应，被批准用于新诊断的慢性髓性白血病慢性期（CML-CP）患者。仿制药作为替代的低成本形式，需求量很大。本研究旨在评估通用达沙替尼（因诗帖）作为 CML-CP 一线治疗的疗效和安全性。
这是一项前瞻性、多中心、单臂研究，于 2016 年 5 月至 2018 年 10 月进行，随访分析时间为 2 年。所有患者均每日给予 100mg（初始剂量）通用达沙替尼一次。主要终点是基于 BCR-ABL1 基因突变率≤0.1%的 12 个月时的主要分子反应（MMR）。
在观察至少 3 个月的 55 例 CP 患者中，80.4%在 12 个月时达到 MMR。24 个月时累积 MR4.5 为 58.2%。反应迅速，69.1%的患者在 3 个月时达到完全细胞遗传学缓解（CCyR），70.9%的患者在 6 个月时达到 CCyR。估计的 2 年无进展生存率和总生存率均为 96%，中位随访时间为 24 个月。发生 3 级中性粒细胞减少症的患者占 8.5%，血小板减少症的患者占 11.9%。非血液学毒性通常较轻且可管理。胸腔积液发生在 20.3%的患者中，只有 1 例（1.7%）患者出现 3 级胸腔积液。未观察到 4 级不良事件。
通用达沙替尼是新诊断的 CML-CP 患者的有效选择，在治疗过程中更早地使更多患者产生 MMR。
