Leukemia research最新文献

英文中文

Treatment with asciminib after a prior tyrosine kinase inhibitor in patients with chronic-phase chronic myeloid leukemia 慢性粒细胞白血病患者既往使用酪氨酸激酶抑制剂后用阿西米尼治疗。

IF 2.2 4区医学 Q3 HEMATOLOGY

Leukemia research

Pub Date : 2025-09-05 DOI: 10.1016/j.leukres.2025.108089

Ehab L. Atallah , Islam Sadek , David Wei , Dominick Latremouille-Viau , Carmine Rossi , Andrea Damon , Daisy Yang , Remi Bellefleur , Annie Guérin , Kejal Jadhav

Background

In chronic-phase chronic myeloid leukemia (CML-CP), switching tyrosine kinase inhibitor (TKI) therapy due to intolerance or resistance is common. While asciminib, an ABL/BCR::ABL1 TKI targeting the ABL myristoyl pocket, offers improved tolerability and efficacy, there is limited real-world effectiveness data, particularly among patients with treatment with one prior TKI.

Patients and methods

A retrospective, US physician panel-based chart review study was conducted on adult patients with CML-CP without T315I treated with asciminib after one prior TKI. Time-on-treatment, and time-to achieving or maintaining MR2 (BCR::ABL1 ≤ 1 %), MMR (BCR::ABL1 ≤ 0.1 %) and DMR (BCR::ABL1 ≤ 0.01 %) were assessed using Kaplan-Meier analyses. Subgroup analyses were performed among patients with first TKI discontinuation due to intolerance or resistance, and by first- or second-generation TKI as first TKI.

Results

Overall, 255 patients (median age 62 years, 56.5 % male) were included. Imatinib (49.8 %), dasatinib (34.5 %), nilotinib (10.6 %), and bosutinib (5.1 %) were received as first TKI. Intolerance and resistance to first TKIs were reported for 43.5 % and 23.5 % of patients, respectively. At 48-weeks post-asciminib initiation, 95.0 % of patients (95 % CI: 91.3 %, 97.1 %) remained on asciminib, 84.0 % (95 % CI: 78.6 %, 88.6 %) achieved or maintained MR2, 68.3 % (95 % CI: 61.8 %, 74.5 %) MMR, and 40.6 % (95 % CI: 34.2 %, 47.8 %) DMR.

Conclusions

Overall, most patients remained on treatment and achieved or maintained MMR, suggesting that asciminib was well-tolerated and effective. Results were consistent among subgroups, indicating that asciminib is an effective option for patients regardless of prior TKI used, and including those intolerant or resistant to their first TKI.

Micro-abstract

There is limited real-world data regarding the effectiveness of asciminib after one prior tyrosine kinase inhibitor (TKI) in chronic-phase chronic myeloid leukemia (CML-CP). In this US physician panel-based chart review, nearly all patients (95 %) remained on asciminib and 68 % achieved or maintained a major molecular response at 48 weeks, suggesting that asciminib is well-tolerated and effective after one prior TKI.

背景：在慢性粒细胞白血病（CML-CP）中，由于不耐受或耐药而切换酪氨酸激酶抑制剂（TKI）治疗是常见的。阿西米尼是一种针对ABL肉豆醇口袋的ABL/BCR::ABL1 TKI，可改善耐受性和疗效，但实际疗效数据有限，特别是在既往有过TKI治疗的患者中。患者和方法：一项回顾性的，美国医师小组为基础的图表回顾研究进行了成人CML-CP患者无T315I治疗阿西米尼之前的TKI。使用Kaplan-Meier分析评估治疗时间、达到或维持MR2 （BCR::ABL1 ≤1 %）、MMR （BCR::ABL1 ≤0.1 %）和DMR （BCR::ABL1 ≤0.01 %）的时间。在因不耐受或耐药而首次停用TKI的患者中进行亚组分析，并将第一代或第二代TKI作为首次TKI。结果：共纳入255例患者（中位年龄62岁，56.5 %为男性）。伊马替尼（49.8% %）、达沙替尼（34.5% %）、尼罗替尼（10.6% %）和博舒替尼（5.1% %）作为第一次TKI。首次TKIs耐受和耐药分别为43.5% %和23.5% %的患者。在48周post-asciminib启动,95.0 %的患者(95 % CI: 91.3 %,97.1 %)仍然在asciminib, 84.0 %(95 % CI: 78.6 %,88.6 %)实现或维护MR2, 68.3 %(95 % CI: 61.8 %,74.5 %)MMR,和40.6 %(95 % CI: 34.2 %,47.8 %)DMR。结论：总体而言，大多数患者继续接受治疗并达到或维持MMR，表明阿西米尼耐受性良好且有效。亚组之间的结果一致，表明阿西米尼对于患者是一种有效的选择，无论之前是否使用过TKI，包括那些对第一次TKI不耐受或耐药的患者。微摘要：关于阿西米尼在既往使用酪氨酸激酶抑制剂（TKI）治疗慢性粒细胞白血病（CML-CP）后的有效性的实际数据有限。在这项基于美国医师小组的图表回顾中，几乎所有患者（95% %）仍在使用阿西米尼，68 %的患者在48周时达到或维持了主要的分子反应，这表明阿西米尼在一次TKI后具有良好的耐受性和有效性。

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引用次数: 0

Efficacy and safety of blinatumomab for CD19 + acute leukemias in patients historically excluded from clinical trials due to comorbidities blinatumomab治疗因合并症而被排除在临床试验之外的CD19 + 急性白血病患者的疗效和安全性

IF 2.2 4区医学 Q3 HEMATOLOGY

Leukemia research

Pub Date : 2025-09-04 DOI: 10.1016/j.leukres.2025.108098

J. Preston Claiborne , Daniel Li , Hua-Ling Tsai , Gabriel Ghiaur , B. Douglas Smith , Mark J. Levis , Amy E. DeZern , Alex J. Ambinder , Tania Jain , Gabrielle T. Prince , Lukasz P. Gondek , Theodoros Karantanos , W. Brian Dalton , Ivana Gojo , Jonathan A. Webster

Background

Blinatumomab has proven efficacy in the frontline, consolidation, and relapsed/refractory settings in B cell acute lymphoblastic leukemia. Its efficacy and safety among patients commonly excluded from clinical trials are unknown.

Patients and Methods

This single center, retrospective cohort study included patients treated for acute leukemia with blinatumomab with the following pre-existing conditions: liver dysfunction, renal impairment, central nervous system (CNS) conditions, autoimmune disease, solid organ transplantation, or uncontrolled infection. Rates of blinatumomab completion, efficacy outcomes, cytokine release syndrome (CRS), neurotoxicity (ICANS), and adverse events specific to the impaired organ leading to inclusion were assessed.

Results

Thirty-four patients were included, and 88 % completed at least one cycle of blinatumomab. One patient stopped prematurely due to toxicity and three due to lack of response in the relapsed/refractory setting. Response rates and survival were similar by treatment setting to those treated in clinical trials. The 60-day cumulative incidence of grade ≥ 2 CRS and ICANS were 23.5 % and 20.8 %, respectively. No excess liver injury, ICANS, autoimmune flares, organ rejection, or infections were observed in cohorts defined by impairment of each system.

Conclusion

Blinatumomab was successfully administered to the vast majority of patients with a baseline condition that would have led to clinical trial exclusion. Adverse events generally occurred at rates similar to prior clinical trials. These data provide the basis to consider removing certain exclusion criteria from future studies involving blinatumomab, allowing more patients to benefit from its efficacy.

背景：blinatumumab已被证明在B细胞急性淋巴细胞白血病的一线、巩固和复发/难治性治疗中有效。它在通常被排除在临床试验之外的患者中的疗效和安全性尚不清楚。患者和方法：这项单中心、回顾性队列研究纳入了接受blinatumomab治疗的急性白血病患者，这些患者先前存在以下疾病：肝功能障碍、肾功能损害、中枢神经系统（CNS）疾病、自身免疫性疾病、实体器官移植或无法控制的感染。评估blinatumomab完成率、疗效结果、细胞因子释放综合征（CRS）、神经毒性（ICANS）和导致纳入受损器官的特异性不良事件。结果：纳入34例患者，88 %完成了至少一个blinatumumab周期。1名患者因毒性过早停药，3名患者因复发/难治性缺乏反应而停药。治疗组的有效率和生存率与临床试验中的治疗组相似。≥ 2级CRS和ICANS的60天累积发生率分别为23.5% %和20.8% %。在每个系统受损的队列中，没有观察到过度的肝损伤、ICANS、自身免疫耀斑、器官排斥或感染。结论：blinatumumab成功地应用于绝大多数基线条件可能导致临床试验被排除的患者。不良事件的发生率与之前的临床试验相似。这些数据为考虑从未来涉及blinatumomab的研究中删除某些排除标准提供了基础，使更多的患者受益于其疗效。

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