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
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
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引用次数: 0

摘要

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。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Efficacy and safety of blinatumomab for CD19 + acute leukemias in patients historically excluded from clinical trials due to comorbidities

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.
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来源期刊
Leukemia research
Leukemia research 医学-血液学
CiteScore
4.00
自引率
3.70%
发文量
259
审稿时长
1 months
期刊介绍: Leukemia Research an international journal which brings comprehensive and current information to all health care professionals involved in basic and applied clinical research in hematological malignancies. The editors encourage the submission of articles relevant to hematological malignancies. The Journal scope includes reporting studies of cellular and molecular biology, genetics, immunology, epidemiology, clinical evaluation, and therapy of these diseases.
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