Nastoupil Loretta J, Andersen Clark R, Ayers Amy, Wang Yucai, Habermann Thomas M, Chihara Dai, Kahl Brad S, Link Brian K, Koff Jean L, Cohen Jonathon B, Martin Peter, Lossos Izidore S, Stanchina Michele, Haddadi Sara, Casulo Carla, Ayyappan Sabarish, Lin Ruitao, Li Ziyi, Larson Melissa A, Maurer Matthew J, Huynh Lynn, Gao Chi, Ramasubramanian Ramya, Duh Mei Sheng, Mutebi Alex, Wang Tongsheng, Jun Monika, Wang Anthony, Kamalakar Rajesh, Kalsekar Anupama, Cerhan James R, Flowers Christopher R
Department of Lymphoma/Myeloma, MD Anderson Cancer Center, Houston, TX.
Department of Lymphoma/Myeloma, MD Anderson Cancer Center, Houston, TX.
Clin Lymphoma Myeloma Leuk. 2025 Apr;25(4):e183-e199.e8. doi: 10.1016/j.clml.2024.11.014. Epub 2024 Dec 16.
Clinical trials provide meaningful data regarding the safety and efficacy of novel therapies but there is often a lag between the time of new drug approval and information on posttreatment clinical outcomes in real-world practice. This study evaluated clinical outcomes in a large real-world population of patients with relapsed and/or refractory large B-cell lymphoma (r/r LBCL) treated with chemoimmunotherapy or novel therapies in second or later lines of therapy (2L+).
Data from the Lymphoma Epidemiology of Outcomes (LEO) Consortium of Real-World Evidence (CReWE) cohort (1/1/2015-2/15/2023) were analyzed. Patients' demographic and clinical characteristics were described and response rates, duration of response, progression-free survival, and overall survival were evaluated. Multivariable Cox proportional hazards regression models were used to assess associations between patient clinical characteristics and outcomes.
The 2L+ cohort included patients treated with chemoimmunotherapy (N = 593), lenalidomide-based therapy (n = 60), polatuzumab vedotin-based therapy (N = 116), tafasitamab-based therapy (N = 55), and loncastuximab tesirine (N = 42). Most patients who received prior chimeric antigen receptor T-cell therapy (CAR-T) were refractory to the treatment. Across all patients, overall response rates were <50%, with one-quarter achieving complete response and median duration of response and overall survival were short (<6 and <10 months, respectively) among patients treated with chemoimmunotherapy or novel therapies. The prognosis was worse for patients who had previously received CAR-T. Primary refractory status, high-risk disease, and failing 3 or more lines of therapy were significantly associated with worse outcomes.
Patients with r/r LBCL have unfavorable outcomes and need more effective treatment alternatives.
临床试验提供了有关新型疗法安全性和有效性的有意义的数据，但新药批准时间与实际临床实践中治疗后临床结果的信息之间往往存在滞后。本研究评估了在二线或更后线治疗（2L+）中接受化疗免疫疗法或新型疗法治疗的大量复发和/或难治性大B细胞淋巴瘤（r/r LBCL）患者的临床结果。
分析了来自真实世界证据淋巴瘤结局流行病学（LEO）联盟队列（2015年1月1日至2023年2月15日）的数据。描述了患者的人口统计学和临床特征，并评估了缓解率、缓解持续时间、无进展生存期和总生存期。使用多变量Cox比例风险回归模型评估患者临床特征与结局之间的关联。
2L+队列包括接受化疗免疫疗法治疗的患者（N = 593）、来那度胺治疗（n = 60）、泊洛妥珠单抗治疗（N = 116）、tafasitamab治疗（N = 55）和loncastuximab tesirine治疗（N = 42）。大多数先前接受嵌合抗原受体T细胞疗法（CAR-T）的患者对该治疗无效。在所有患者中，总体缓解率<50%，四分之一达到完全缓解，接受化疗免疫疗法或新型疗法治疗的患者缓解持续时间和总生存期的中位数较短（分别<6个月和<10个月）。先前接受过CAR-T治疗的患者预后较差。原发性难治状态、高危疾病以及三线或更多线治疗失败与更差的结局显著相关。
r/r LBCL患者预后不佳，需要更有效的治疗选择。
