Objective: To evaluate the effect of autologous hematopoietic stem cell transplantation (ASCT) on the treatment of relapsed/refractory multiple myeloma (RRMM) with chimeric antigen receptor T cell (CAR-T) therapy. Methods: A retrospective cohort study. The clinical data of 168 patients with RRMM who underwent CAR-T therapy at the Department of Hematology, Xuzhou Medical University Hospital from 3 January 2020 to 13 September 2022 were analyzed. Patients were classified into a transplantation group (TG; n=47) and non-transplantation group (NTG; n=121) based on whether or not they had undergone ASCT previously. The objective response rate (ORR), progression-free survival (PFS), overall survival (OS) and the levels of CD3, CD4, CD8, CD19, CD56 and natural killer (NK) cells before CAR-T infusion were analyzed by χ2 test, Kaplan-Meier method and independent sample t-test. Results: Among 168 patients with RRMM, 98 (58.3%) were male. The median age of onset was 57 (range 30-70) years. After CAR-T therapy, the ORR of patients was 89.3% (92/103) in the NTG and 72.9% (27/73) in the TG. The ORR of the NTG was better than that of the TG (χ2=5.71, P=0.017). After 1 year of CAR-T therapy, the ORR of the NTG was 78.1% (75/96), and that of the TG was 59.4% (19/32). The ORR of the NTG was better than that of the TG (χ2=4.32, P=0.038). The median OS and PFS in the NTG were significantly longer than those in the TG (OS, 30 vs. 20 months; PFS, 26 vs. 12 months; both P<0.05). The CD4 level before CAR-T infusion in the TG was significantly lower than that in the NTG (25.65±13.56 vs. 32.64±17.21; t=-2.15, P=0.034), and there were no significant differences in the counts of CD3, CD8, CD19, CD56, and NK cells between the TG and NTG (all P>0.05). Conclusion: Among patients suffering from RRMM who received CAR-T therapy, patients who did not receive ASCT had significantly better outcomes than those who had received ASCT previously, which may have been related to the CD4 level before receiving CAR-T therapy.
目的： 评价自体造血干细胞移植（ASCT）对抗原嵌合受体-T细胞（CAR-T）治疗复发/难治性多发性骨髓瘤（RRMM）疗效的影响。 方法： 回顾性队列研究。收集2020年1月3日至2022年9月13日于徐州医科大学附属医院血液科接受CAR-T治疗的168例RRMM患者的临床资料，依据既往是否接受ASCT分为移植组（47例）与未移植组（121例），采用χ2检验、Kaplan-Meier生存分析及独立样本t检验等方法统计分析两组患者客观缓解率（ORR）、无进展生存（PFS）时间、总生存（OS）时间，以及两组患者CAR-T输注前CD3、CD4、CD8、CD19、CD56、自然杀伤（NK）细胞水平。 结果： 168例RRMM患者中，男性98例（58.3%），发病中位年龄57岁（范围30~70岁）。两组患者输注CAR-T细胞后，未移植组ORR为89.3%（92/103），移植组ORR为72.9%（27/37）；1年后再次评估疗效，未移植ORR为78.1%（75/96），移植组ORR为59.4%（19/32），未移植组ORR均优于移植组ORR（χ2=5.71、4.32，P=0.017、0.038）。未移植组患者中位OS及PFS时间均大于移植组患者（OS：30个月比20个月，PFS：26个月比12个月；均P<0.05）。移植组患者CAR-T输注前的CD4水平显著低于未移植组患者（25.65±13.56比32.64±17.21；t=-2.15，P=0.034），CD3、CD8、CD19、CD56及NK细胞计数两组间差异均无统计学意义（均P>0.05）。 结论： 在接受CAR-T治疗的RRMM患者中，未行ASCT患者的疗效明显好于既往行ASCT患者，可能与接受CAR-T治疗前CD4水平有关。.