研究概要
在这项真实世界分析中,我们利用国际血液与骨髓移植研究中心登记数据库,评估了 2021 年 3 月至 2023 年 12 月期间在既往接受 4 线治疗后接受 ide-cel 治疗的 807 例 RRMM 患者。
中文摘要
嵌合抗原受体(CAR)T细胞治疗后感染较常见,并会增加发病率和死亡率。CD19 CAR-T 细胞治疗后的感染特征已较为明确,但B细胞成熟抗原(BCMA)CAR-T 细胞治疗相关感染的数据有限。本研究旨在描述接受idecabtagene vicleucel(ide-cel)治疗的复发/难治性多发性骨髓瘤(RRMM)患者感染的负担、模式、危险因素及其对结局的临床影响。我们利用国际血液与骨髓移植研究中心登记数据库,对2021年3月至2023年12月间接受ide-cel治疗、既往至少接受4线治疗的807例RRMM患者开展真实世界分析。ide-cel治疗后100天内,各类感染的感染密度为0.49;细菌、病毒和真菌感染分别为0.23、0.22和0.012。输注后前30天以细菌感染为主,而第+30至+100天病毒感染更常见。存活患者中位随访11.6个月后,364例复发、222例死亡;1年无进展生存率为46.5%,总生存率(OS)为67.3%。疾病进展是最主要死因,其次为感染。至第+100天,感染相关死亡率为1.1%。多变量Cox回归显示,ide-cel治疗前感染史、体能状态较差(KPS<80)、2级细胞因子释放综合征和3级神经毒性是感染的独立预测因素。治疗后100天内反复感染(≥2次)以及100天内复发均与OS较差相关。感染在ide-cel治疗后较常见,并可能导致结局变差,凸显了风险分层、监测和严格感染预防策略对于优化疗效的重要性。
展开英文摘要原文
Infections are common after chimeric antigen receptor (CAR) T-cell therapy and contribute to morbidity and mortality. While well characterized with CD19 CAR T-cells, data related to infections with B-cell maturation antigen (BCMA) CAR T-cell therapy are limited. This study aims to characterize the burden, patterns, risk factors, and clinical impact of infections on outcomes in patients with relapsed/refractory multiple myeloma (RRMM) treated with idecabtagene vicleucel (ide-cel). In this real-world analysis, we evaluated 807 patients with RRMM who received ide-cel after 4 prior lines of therapy between March 2021 and December 2023, using the Center for International Blood and Marrow Transplant Registry database. The infection density within 100 d post-ide-cel was 0.49 for any infection, and 0.23, 0.22, and 0.012 for bacterial, viral, and fungal infections, respectively. Bacterial infections predominated during the first 30 d post-infusion, whereas viral infections were more prevalent between day +30 and d +100. After a median follow-up among survivors of 11.6 months, 364 patients relapsed and 222 died, translating into a 1-yr progression-free survival of 46.5% and overall survival (OS) of 67.3%. Disease progression was the leading cause of death, followed by infections. Infection-related mortality was 1.1% at d +100. On multivariable Cox regression, baseline infection history prior to ide-cel, poor performance status (KPS<80), grade 2 cytokine release syndrome, and grade 3 neurotoxicity were independent predictors of infection. Recurrent infections ( 2 events) within 100 d and relapse within 100 d after ide-cel were associated with inferior OS. Infections are common and can result in inferior outcomes after ide-cel, underscoring the importance of risk stratification, surveillance, and stringent infection prevention strategies to optimize outcomes.
论文信息
- 作者
- Wudhikarn K、Gowda L、Ye Q、Oloyede T、Martens M、Banerjee R、Devarakonda SS、Liu H
- 第一作者单位
- Division of Hematology and Center of Excellence in Translational Hematology, Chulalongkorn University, Bangkok, Thailand.Thailand
- 通讯作者单位
- CIBMTR® (Center for International Blood and Marrow Transplant Research), Medical College of Wisconsin, Milwaukee, Wisconsin; Division of Pediatric Infectious Diseases, Department of Pediatrics, Medical College of Wisconsin, Milwaukee, Wisconsin. Electronic address: ahuppler@mcw.edu.United States
- 期刊
- Transplantation and cellular therapy2026 Jun 27