Sermer David, Batlevi Connie, Palomba M Lia, Shah Gunjan, Lin Richard J, Perales Miguel-Angel, Scordo Michael, Dahi Parastoo, Pennisi Martina, Afuye Aishat, Silverberg Mari Lynne, Ho Caleb, Flynn Jessica, Devlin Sean, Caron Philip, Hamilton Audrey, Hamlin Paul, Horwitz Steven, Joffe Erel, Kumar Anita, Matasar Matthew, Noy Ariela, Owens Colette, Moskowitz Alison, Straus David, von Keudell Gottfried, Rodriguez-Rivera Ildefonso, Falchi Lorenzo, Zelenetz Andrew, Yahalom Joachim, Younes Anas, Sauter Craig
Lymphoma Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY.
Department of Medicine, Weill Cornell Medical College, New York, NY; and.
Blood Adv. 2020 Oct 13;4(19):4669-4678. doi: 10.1182/bloodadvances.2020002118.
The prognosis of patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) is poor. Chimeric antigen receptor (CAR) T-cell therapy has been approved for R/R DLBCL after 2 prior lines of therapy based on data from single-arm phase 2 trials, with complete responses (CRs) in 40% to 60% of patients. However, a direct comparison with other treatments is not available and, moreover, its true efficacy in real-world patients is unknown. In this single center, retrospective, observational study of 215 patients, we compared outcomes in patients treated with CAR T-cell therapy (n = 69) with a historical population treated with alternate therapies (n = 146). Patients treated with CAR T cell vs alternate therapies demonstrated a CR rate of 52% vs 22% (P < .001), median progression-free survival (PFS) of 5.2 vs 2.3 months (P = .01), and median overall survival (OS) of 19.3 vs 6.5 months (P = .006), and this advantage appeared to persist irrespective of the number of lines of prior therapy. After adjusting for unfavorable pretreatment disease characteristics, superior overall response rate in the CAR T cohort remained significant; however, differences in PFS and OS between cohorts did not. In addition, patients who responded to alternate therapies demonstrated prolonged remissions comparable to those who responded to CAR T therapy. We contend that in select clinical scenarios alternate therapies may be as efficacious as CAR T therapy; thus, additional study is warranted, ideally with randomized prospective trials.
复发或难治性(R/R)弥漫性大B细胞淋巴瘤(DLBCL)患者的预后较差。基于单臂2期试验的数据,嵌合抗原受体(CAR)T细胞疗法已被批准用于经过2线先前治疗后的R/R DLBCL,40%至60%的患者获得完全缓解(CR)。然而,目前尚无与其他治疗方法的直接比较,而且其在真实世界患者中的真正疗效尚不清楚。在这项针对215例患者的单中心回顾性观察研究中,我们比较了接受CAR T细胞疗法治疗的患者(n = 69)与接受其他替代疗法治疗的历史队列患者(n = 146)的治疗结果。接受CAR T细胞治疗与接受其他替代疗法的患者相比,CR率分别为52%和22%(P <.001),无进展生存期(PFS)中位数分别为5.2个月和2.3个月(P =.01),总生存期(OS)中位数分别为19.3个月和6.5个月(P =.006),而且无论先前治疗的线数如何,这种优势似乎都持续存在。在调整了不利的预处理疾病特征后,CAR T队列中较高的总体缓解率仍然显著;然而,队列之间在PFS和OS方面的差异不再显著。此外,对其他替代疗法有反应的患者表现出与对CAR T疗法有反应的患者相当的缓解期延长。我们认为,在某些临床情况下,其他替代疗法可能与CAR T疗法一样有效;因此,有必要进行进一步研究,理想情况下是进行随机前瞻性试验。