1. Comparison of CAR-T19 and autologous stem cell transplantation for refractory/relapsed non-Hodgkin’s lymphoma
- Author
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Liqing Kang, Caixia Li, Jin Zhou, Xiuli Sun, Xiaochen Chen, Zhengming Jin, Jia Chen, Ting Xu, Changfeng Zhang, Nan Xu, Pu Wang, Xiangping Zong, Jingwen Tan, Changju Qu, Xiaoyan Lou, Ying Zhang, Zhen Yang, Haiwen Huang, Minghao Li, Lei Yu, and Depei Wu
- Subjects
0301 basic medicine ,Male ,medicine.medical_specialty ,Receptors, Antigen, T-Cell ,Kaplan-Meier Estimate ,Single Center ,Gastroenterology ,Immunotherapy, Adoptive ,Transplantation, Autologous ,03 medical and health sciences ,0302 clinical medicine ,Autologous stem-cell transplantation ,Internal medicine ,Medicine ,Humans ,Prospective Studies ,Adverse effect ,Aged ,Bone Marrow Transplantation ,Aged, 80 and over ,Cytopenia ,Hematology ,business.industry ,Standard treatment ,Lymphoma, Non-Hodgkin ,Hematopoietic Stem Cell Transplantation ,General Medicine ,Middle Aged ,medicine.disease ,Survival Analysis ,Transplantation ,Cytokine release syndrome ,030104 developmental biology ,030220 oncology & carcinogenesis ,Multivariate Analysis ,Female ,Clinical Medicine ,business - Abstract
BACKGROUND: Autologous stem cell transplantation (ASCT) is the standard treatment for refractory/relapsed B cell non-Hodgkin’s lymphoma (R/R B-NHL), whereas chimeric antigen receptor T (CAR-T) therapy targeting CD19 is emerging as an alternative strategy. Here, we report a comparative analysis of the 2 strategies in a single center. METHODS: We performed a prospective, single-arm study of CAR-T therapy in 29 patients with R/R B-NHL and compared the outcomes with 27 contemporaneous patients who received ASCT. NHL was diagnosed by histopathologic assessments, and the safety and efficacy of treatments were compared. RESULTS: The CAR-T group exhibited better rates of complete response (CR) (48.0% vs. 20.8%, P = 0.046) and 1-year overall survival (OS) (74.4% vs. 44.5%, P = 0.044) compared with the ASCT group. Subpopulation analysis showed that patients with International Prognostic Index scores of at least 3 achieved a significantly higher objective response rate and CR rate in the CAR-T group than in the ASCT group (ORR 72.0% vs. 10.0%, P = 0.002, and CR 38.9% vs. 0%, P = 0.030, respectively). The most common severe adverse events in the CAR-T group were cytokine release syndrome, neurotoxicity, and infection compared with cytopenia, gastrointestinal toxicity, and infection in the ASCT group. Additionally, the incidence of nonhematologic severe adverse events was markedly lower in the CAR-T group than in the ASCT group (20.7% vs. 48.1%, P = 0.030). CONCLUSION: CAR-T therapy exhibited superior clinical outcomes in safety and efficacy over ASCT in patients with R/R B-NHL, suggesting that CAR-T may be a recommended alternative to ASCT. TRIAL REGISTRATION: ClinicalTrials.gov NCT03196830. FUNDING: Funding was supplied by UniCar Therapy, National Natural Science Foundation of China (81730003), National Science and Technology Major Project (2017ZX09304021), and Science Planning Project of Suzhou (sys2018049).
- Published
- 2019