Guo Zhi, Xian Xiaomin, Xiang Xiaochen, Wang Jun, Sun Zhiqiang, Wang Yueqiao, Xie Jing, Meng Jingye, Li Yongqian, Zhou Min, Li Guowei, Lu Bo, Xu Xiaojun, Wang Liang, Wang Qiang
Institute of Infection, Immunology and Tumor Microenvironment, Hubei Province Key Laboratory of Occupational Hazard Identification and Control, School of Medicine, Wuhan University of Science and Technology, Wuhan, China.
Department of Hematology, The 6 Affiliated Hospital of Shenzhen University Health Science Center, Shenzhen, China.
J Cancer Res Ther. 2025 May 1;21(2):447-456. doi: 10.4103/jcrt.jcrt_2102_24. Epub 2025 May 2.
The ability of autologous hematopoietic stem cell transplantation (ASCT) to improve the benefit of patients with high-risk diffuse large B-cell lymphoma (DLBCL) who achieved complete remission (CR) following induction chemotherapy is controversial. This multicenter real-world study aimed to explore the efficacy and safety of the rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) regimen followed by consolidated ASCT therapy in newly diagnosed DLBCL.
From June 2018 to June 2021, the clinical data of patients with high-risk DLBCL who reached CR after receiving the R-CHOP regimen from ten lymphoma diagnosis and treatment centers were analyzed. Patients were included in the R-CHOP+ASCT (with consolidated ASCT therapy, n = 60) and R-CHOP (follow-up without consolidated ASCT therapy, n = 60) groups. The efficacy in the two groups was compared by difference analysis, and the safety of R-CHOP+ASCT was analyzed.
Until June 2024, the median follow-up times for the R-CHOP+ASCT and R-CHOP groups were 44 (37.25-56) and 43.5 (38-52) months, respectively. Survivors were followed up for at least 36 months. In the R-CHOP+ASCT group, the 3-year disease-free survival (DFS) and overall survival (OS) rates were 89.7% and 96.7% and those in the R-CHOP group were 63.9% and 85.9%, respectively. The 3-year DFS rate in the R-CHOP+ASCT group was significantly higher than that in the R-CHOP group (89.7% vs 63.9%, P = 0.001); no significant difference was found in the 3-year OS rate between the R-CHOP+ASCT and R-CHOP groups (96.7% vs 85.9%, P = 0.113). The 5-year DFS and OS rates in the R-CHOP+ASCT group were 73.6% and 77.6% and those in the R-CHOP group were 56.5% and 81.1%, respectively. The 5-year DFS rate in the R-CHOP+ASCT group was significantly higher than that in the R-CHOP group (73.6% vs 56.5%, P = 0.009), whereas no significant difference was found in the 5-year OS rate between the R-CHOP+ASCT and R-CHOP groups (77.6% vs 81.1%, P = 0.246). In the Cox multifactorial analysis, discontinuous consolidated ASCT therapy, bone marrow invasion, and dual expression were poor prognostic factors that affect DFS [hazard ratio (HR), 5.710; 95% confidence interval (CI), 2.241-14.548, P < 0.001; HR, 4.324; 95% CI, 1.890-9.893, P = 0.001; HR, 2.565; 95% CI, 1.145-5.747, P = 0.022, respectively] and dual expression was a poor prognostic factor for OS (HR, 3.486; 95% CI, 1.300-9.344, P = 0.013). Grade IV myelosuppression after transplantation developed in the R-CHOP+ASCT group, and other common grade 3 or 4 treatment-related adverse events were infection and fever.
For patients with newly diagnosed high-risk DLBCL, consolidated ASCT therapy can increase the DFS rate of those with CR status following the R-CHOP regimen, and the safety is controllable.
自体造血干细胞移植(ASCT)能否提高诱导化疗后达到完全缓解(CR)的高危弥漫性大B细胞淋巴瘤(DLBCL)患者的获益存在争议。这项多中心真实世界研究旨在探讨利妥昔单抗联合环磷酰胺、多柔比星、长春新碱和泼尼松(R-CHOP)方案序贯巩固性ASCT治疗新诊断DLBCL的疗效和安全性。
分析2018年6月至2021年6月期间,来自10个淋巴瘤诊疗中心接受R-CHOP方案后达到CR的高危DLBCL患者的临床资料。患者被纳入R-CHOP+ASCT组(接受巩固性ASCT治疗,n = 60)和R-CHOP组(未接受巩固性ASCT治疗进行随访,n = 60)。通过差异分析比较两组的疗效,并分析R-CHOP+ASCT的安全性。
截至2024年6月,R-CHOP+ASCT组和R-CHOP组的中位随访时间分别为44(37.25 - 56)个月和43.5(38 - 52)个月。存活者至少随访36个月。在R-CHOP+ASCT组,3年无病生存率(DFS)和总生存率(OS)分别为89.7%和96.7%,R-CHOP组分别为63.9%和85.9%。R-CHOP+ASCT组的3年DFS率显著高于R-CHOP组(89.7%对63.9%,P = 0.001);R-CHOP+ASCT组和R-CHOP组的3年OS率无显著差异(96.7%对85.9%,P = 0.113)。R-CHOP+ASCT组的5年DFS和OS率分别为73.6%和77.6%,R-CHOP组分别为56.5%和81.1%。R-CHOP+ASCT组的5年DFS率显著高于R-CHOP组(73.6%对56.5%,P = 0.009),而R-CHOP+ASCT组和R-CHOP组的5年OS率无显著差异(77.6%对81.1%,P = 0.246)。在Cox多因素分析中,间断巩固性ASCT治疗、骨髓侵犯和双表达是影响DFS的不良预后因素[风险比(HR),5.710;95%置信区间(CI),2.241 - 14.548,P < 0.001;HR,4.324;95% CI,1.890 - 9.893,P = 0.001;HR,2.565;95% CI,1.145 - 5.747,P = 0.022],双表达是OS的不良预后因素(HR,3.486;95% CI,1.300 - 9.344,P = 0.013)。R-CHOP+ASCT组移植后出现IV级骨髓抑制,其他常见的3级或4级治疗相关不良事件为感染和发热。
对于新诊断的高危DLBCL患者,巩固性ASCT治疗可提高R-CHOP方案后达到CR状态患者的DFS率,且安全性可控。