国产达沙替尼二线治疗慢性髓性白血病慢性期患者的疗效和安全性分析

Efficacy and safety of domestic dasatinib as second-line treatment for chronic myeloid leukemia patients in the chronic phase

目的探讨国产酪氨酸激酶抑制剂(TKI)达沙替尼(商品名:依尼舒)二线治疗慢性髓性白血病慢性期(CML-CP)患者的疗效及安全性。方法回顾性分析2016年3月至2018年7月湖北省CML协作组成员医院收治的二线服用国产达沙替尼的CML-CP患者的病例资料,统计患者治疗3、6和12个月时最佳反应率、累积完全细胞遗传学反应(CCyR)率、累积主要分子学反应(MMR)率、无进展生存(PFS)、无事件生存(EFS)情况及不良反应情况。结果共纳入83例CML-CP患者,中位随访时间为23(4~45)个月,达沙替尼治疗3、6、12个月最佳反应率分别为77.5%(54/71)、72.6%(61/75)、60.7%(51/69)。至随访截止,累积CCyR率、MMR率分别为65.5%(55/80)、57.1%(48/73),达CCyR和MMR的中位时间均为3个月。随访时间内,PFS率为94.0%(79/83),EFS率为77.4%(65/83)。国产达沙替尼最常见非血液学不良反应为水肿(32.5%),其次为皮疹瘙痒(18.1%)、乏力(13.3%),血液学不良反应主要有血小板减少(31.3%)、白细胞减少(19.3%)和贫血(6.0%)。结论国产达沙替尼二线治疗CML-CP患者具有较好的疗效及安全性,可作为CML-CP患者的治疗选择。

Objective To investigate the efficiency and safety of domestic tyrosine kinase inhibitor (TKI) dasatinib (Yinishu) as second-line treatment for patients with chronic myeloid leukemia in chronic phase (CML-CP). Methods A retrospective analysis of clinical data of CML-CP patients who received domestic dasatinib as second-line treatment in the CML collaborative group hospitals of Hubei province from March 2016 to July 2018 was performed. The optimal response rate, the cumulative complete cytogenetic response (CCyR), the cumulative major molecular responses (MMR), progression free survival (PFS), event free survival (EFS) and adverse effects (AEs) of the patients were assessed at 3, 6 and 12 months of treatment. Results A total of 83 CML-CP patients were enrolled in this study. The median follow-up time was 23 months. The optimal response rates at 3, 6 and 12 months in 83 CML-CP patients treated with dasatinib were 77.5%(54/71), 72.6%(61/75) and 60.7%(51/69), respectively. By the end of follow-up, the cumulative CCyR and MMR rates were 65.5%(55/80) and 57.1%(48/73), respectively. The median time to achieving CCyR and MMR was 3 months. During follow-up time, the PFS rate was 94.0%(79/83) and the EFS rate was 77.4%(65/83). The most common non-hematological AEs of dasatinib were edema (32.5%), rash itching (18.1%) and fatigue (13.3%). The common hematological AEs of dasatinib were thrombocytopenia (31.3%), leukopenia (19.3%) and anemia (6.0%). Conclusion Domestic dasatinib was effective and safe as the second-line treatment of CML-CP patients and it can be used as an option for CML-CP patients.