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摘要
Background @@@ This study aimed to systematically evaluate and compare the efficacy and safety of consolidative hematopoietic stem cell transplantation (HSCT) after CD19 chimeric antigen receptor T (CAR-T) therapy with non-HSCT in the treatment of acute lymphoblastic leukemia (ALL). @@@ Methods @@@ The PubMed, Embase, Cochrane Library and Web of Science databases were searched for clinical trials. Pooled hazard ratios (HRs) for overall survival (OS), relapse rate, and leukemia-free survival (LFS) as well as overall incidence rates for transplant-related mortality (TRM), acute graft-versus-host disease (aGVHD), chronic graft-versus-host disease (cGVHD), and infections were calculated using Stata software. @@@ Results @@@ We screened 3,441 studies and identified 19 eligible studies with 690 patients. Among the patients who achieved complete remission (CR) after CD19 CAR-T therapy, consolidative HSCT was beneficial for OS (HR = 0.34, 95% CI, 0.17-0.68, P = 0.003), the relapse rate (HR = 0.16, 95% CI, 0.10-0.25, P < 0.001), and LFS (HR = 0.15, 95% CI, 0.08-0.28, P < 0.001). For patients who achieved MRD-negative (neg) CR after CD19 CAR-T therapy, consolidative HSCT was beneficial for OS (0.57, 95% CI, 0.33-0.99, P = 0.045), the relapse rate (0.14, 95% CI, 0.06-0.31, P < 0.001), and LFS (0.21, 95% CI, 0.12-0.35, P < 0.001). Regarding safety, we calculated pooled incidence rates for TRM (8%, 95% CI, 0.02-0.15), aGVHD (44%, 95% CI, 0.23-0.67), cGVHD (36%, 95% CI, 0.17-0.56), and infections (39%, 95% CI, 0.03-0.83). @@@ Conclusions @@@ Compared with non-HSCT treatment, consolidative HSCT after CD19 CAR-T therapy for R/R B-ALL patients can prolong OS and LFS and reduce the risk of relapse. The incidence rates for adverse events are acceptable. More high-quality randomized controlled trials are required to avoid bias and further determine the efficacy of HSCT.
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单位中国医学科学院; 南方医科大学
