Hematologic Malignancies and Cellular Therapeutics, The University of Kansas Medical Center, Kansas City, Kansas.
Oncology Hematology Care, Cincinnati, Ohio.
Clin Adv Hematol Oncol. 2023 Apr;21(4):170-178.
The landscape for the treatment of patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) has continued to evolve. However, challenges continue to exist, particularly in patients who do not respond to first-line anti-CD20 monoclonal antibody and anthracycline-based therapy or those who experience early relapse. In such patients, the treatment paradigm has changed little in the past 2 decades, with salvage chemotherapy followed by myeloablative chemotherapy and autologous hematopoietic stem cell transplant resulting in historical durable response rates of approximately 40%. Given the success of chimeric antigen receptor (CAR) T-cell therapy in the third- or later-line in the R/R LBCL setting, 3 recent clinical trials (ZUMA-7, BELINDA, and TRANSFORM) have sought to address the clinical need for improved therapies in the high-risk second-line setting for primary R/R disease in the first 12 months. In this review, we analyze these 3 pivotal trials with a focus on clinical trial design, CAR T-cell product attributes, efficacy data, safety data, and patient-reported outcomes when compared with standard of care.
复发或难治性（R/R）大 B 细胞淋巴瘤（LBCL）患者的治疗格局不断发展。然而，挑战仍然存在，特别是在一线抗 CD20 单克隆抗体和蒽环类药物治疗无应答或早期复发的患者中。在过去的 20 年中，此类患者的治疗模式几乎没有变化，挽救性化疗后进行清髓性化疗和自体造血干细胞移植，历史上的持久缓解率约为 40%。鉴于嵌合抗原受体（CAR）T 细胞疗法在 R/R LBCL 三线或更后线治疗中的成功，3 项最近的临床试验（ZUMA-7、BELINDA 和 TRANSFORM）旨在解决高危二线治疗的临床需求，即对于前 12 个月内原发性 R/R 疾病的一线治疗。在这篇综述中，我们分析了这 3 项关键性试验，重点关注临床试验设计、CAR T 细胞产品属性、疗效数据、安全性数据以及与标准治疗相比的患者报告结局。
