Blinatumomab administration in the outpatient setting: Safety and health care utilization

IF 5.6 2区医学 Q1 ONCOLOGY

Cancer Pub Date : 2026-08-18 DOI:10.1002/cncr.70566

Yannis K. Valtis MD, Benjamin F. Frost MD, David Nemirovsky MA, Andriy Derkach PhD, Kuo-Kai Chin MD, Meira Yisraeli Salman MD, Leora Boussi MD, Natalia Tijaro Ovalle MD, Emilie Baxter BA, Ann Mercurio MD, Eytan M. Stein MD, Mark B. Geyer MD, Deborah Schrag MD, MPH, Amar H. Kelkar MD, Daniel J. DeAngelo MD, Marlise R. Luskin MD, Jae H. Park MD, Evan C. Chen MD

{"title":"Blinatumomab administration in the outpatient setting: Safety and health care utilization","authors":"Yannis K. Valtis MD, Benjamin F. Frost MD, David Nemirovsky MA, Andriy Derkach PhD, Kuo-Kai Chin MD, Meira Yisraeli Salman MD, Leora Boussi MD, Natalia Tijaro Ovalle MD, Emilie Baxter BA, Ann Mercurio MD, Eytan M. Stein MD, Mark B. Geyer MD, Deborah Schrag MD, MPH, Amar H. Kelkar MD, Daniel J. DeAngelo MD, Marlise R. Luskin MD, Jae H. Park MD, Evan C. Chen MD","doi":"10.1002/cncr.70566","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Background</h3>\n \n <p>Blinatumomab, a bispecific CD19 × CD3 antibody is effective for the treatment of B-cell acute lymphoblastic leukemia (ALL). Because of its immune toxicities, namely cytokine release syndrome (CRS) and immune effector cell–associated neurotoxicity syndrome (ICANS), the US Food and Drug Administration (FDA) recommends preemptive hospitalization for the initiation of cycle 1 (C1) and cycle 2 (C2). The necessity of this approach is unclear.</p>\n </section>\n \n <section>\n \n <h3> Methods</h3>\n \n <p>The authors conducted a retrospective cohort study among all patients treated with blinatumomab between 2012 and 2025 at two academic cancer centers: Memorial Sloan Kettering Cancer Center (MSK) and Dana-Farber Cancer Institute (DFCI).</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>For C1, only nine of 308 (3%) patients initiated outpatient (OP) treatment. A total of 184 of 308 (60%) initiated C2: At DFCI, 10 of 83 (12%) initiated C2 OP and at MSK, and 74 of 101 (88%) initiated C2 OP. Demographic and clinical characteristics were similar between patients initiating C2 inpatient versus OP. No patients who initiated C2 (0 of 184) had Gr3+ CRS (across all cycles) and only two (1%) had Gr3+ ICANS; both were inpatient for C2. Of 84 patients treated without preemptive hospitalization for C2, 16 of 84 (19%) required hospitalization at some point during the cycle, largely for infections (50%).</p>\n </section>\n \n <section>\n \n <h3> Conclusions</h3>\n \n <p>OP administration of C2 of blinatumomab can be administered safely with no unexpected, severe, or life-threatening toxicities. The ability to safely manage treatment without preemptive hospitalization may support the patient experience and limit costs of care.</p>\n </section>\n </div>","PeriodicalId":138,"journal":{"name":"Cancer","volume":"132 16","pages":""},"PeriodicalIF":5.6000,"publicationDate":"2026-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Cancer","FirstCategoryId":"3","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1002/cncr.70566","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ONCOLOGY","Score":null,"Total":0}

引用次数: 0

Abstract

Background

Blinatumomab, a bispecific CD19 × CD3 antibody is effective for the treatment of B-cell acute lymphoblastic leukemia (ALL). Because of its immune toxicities, namely cytokine release syndrome (CRS) and immune effector cell–associated neurotoxicity syndrome (ICANS), the US Food and Drug Administration (FDA) recommends preemptive hospitalization for the initiation of cycle 1 (C1) and cycle 2 (C2). The necessity of this approach is unclear.

Methods

The authors conducted a retrospective cohort study among all patients treated with blinatumomab between 2012 and 2025 at two academic cancer centers: Memorial Sloan Kettering Cancer Center (MSK) and Dana-Farber Cancer Institute (DFCI).

Results

For C1, only nine of 308 (3%) patients initiated outpatient (OP) treatment. A total of 184 of 308 (60%) initiated C2: At DFCI, 10 of 83 (12%) initiated C2 OP and at MSK, and 74 of 101 (88%) initiated C2 OP. Demographic and clinical characteristics were similar between patients initiating C2 inpatient versus OP. No patients who initiated C2 (0 of 184) had Gr3+ CRS (across all cycles) and only two (1%) had Gr3+ ICANS; both were inpatient for C2. Of 84 patients treated without preemptive hospitalization for C2, 16 of 84 (19%) required hospitalization at some point during the cycle, largely for infections (50%).

Conclusions

OP administration of C2 of blinatumomab can be administered safely with no unexpected, severe, or life-threatening toxicities. The ability to safely manage treatment without preemptive hospitalization may support the patient experience and limit costs of care.

查看原文本刊更多论文

布利纳单抗在门诊治疗中的应用：安全性和保健应用

背景：双特异性CD19 × CD3抗体Blinatumomab可有效治疗b细胞急性淋巴细胞白血病（ALL）。由于其免疫毒性，即细胞因子释放综合征（CRS）和免疫效应细胞相关神经毒性综合征（ICANS），美国食品和药物管理局（FDA）建议在周期1 （C1）和周期2 （C2）开始时先住院治疗。这种做法的必要性尚不清楚。方法：作者对2012年至2025年间在两个学术癌症中心（Memorial Sloan Kettering cancer Center （MSK）和Dana-Farber cancer Institute (DFCI)）接受blinatumomab治疗的所有患者进行了回顾性队列研究。结果对于C1, 308例患者中只有9例（3%）开始了门诊治疗。308例患者中有184例（60%）启动了C2：在DFCI， 83例患者中有10例（12%）启动了C2 OP和MSK， 101例患者中有74例（88%）启动了C2 OP。在住院患者和OP中启动C2的患者中，人口统计学和临床特征相似。启动C2的患者（184例中0例）没有Gr3+ CRS（所有周期），只有2例（1%）有Gr3+ ICANS；两人都因C2住院。在84例未因C2预先住院治疗的患者中，84例中有16例（19%）需要在周期内的某个时间点住院，主要是感染（50%）。结论：布利纳单抗C2的OP给药是安全的，没有意外的、严重的或危及生命的毒性。在没有预先住院的情况下安全管理治疗的能力可以支持患者体验并限制护理成本。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Cancer 医学-肿瘤学

CiteScore

13.10

自引率

3.20%

发文量

480

审稿时长

2-3 weeks

期刊介绍： The CANCER site is a full-text, electronic implementation of CANCER, an Interdisciplinary International Journal of the American Cancer Society, and CANCER CYTOPATHOLOGY, a Journal of the American Cancer Society. CANCER publishes interdisciplinary oncologic information according to, but not limited to, the following disease sites and disciplines: blood/bone marrow; breast disease; endocrine disorders; epidemiology; gastrointestinal tract; genitourinary disease; gynecologic oncology; head and neck disease; hepatobiliary tract; integrated medicine; lung disease; medical oncology; neuro-oncology; pathology radiation oncology; translational research