文章：

验证POD24作为套细胞淋巴瘤生存预后不良的稳健早期临床指标：一项基于1280例临床试验患者的LYSA研究

Validation of POD24 as a robust early clinical indicator of poor survival in mantle cell lymphoma from 1280 patients on clinical trials, a LYSA study

原文发布日期：2025-04-24

DOI: 10.1038/s41408-025-01241-9

类型: Article

开放获取: 是

英文摘要：

In mantle cell lymphoma, early progression of disease has been associated with short overall survival. The impact of clinical, pathological, and treatment strategies on the risk of early relapse has not been assessed in a large cohort of patients. We performed a pooled analysis of patients recruited in France from six randomized first-line MCL trials. Among 1386 treated MCL patients, 1280 were evaluable for POD24 status: 299 (23.4%) with a POD24 event and 981 (76.6%) without. Patients with a POD24 event had a median OS of 9.3 months (95% CI 8.4–11.8) versus not reached (95% CI 97.8–NR) for those without POD24 events. The median post-relapse OS of patients with a late relapse was also significantly longer at 49.4 months (HR = 0.39; 95% CI 0.31–0.48; P < 0.001) as compared to POD24 patients. Baseline variables (age, performance status, B symptoms, LDH/ULN, leukocytes, blastoid variant, and Ki-67 > 30%) were significantly associated with the risk of POD24, independent of ASCT. Among responding patients at end-of-induction (n = 1105) who had received ASCT, anti-CD20 maintenance was associated with a decreased risk of POD24 (OR = 0.37; 95% CI 0.1–1.0). Using this large data set of patients in clinical trials, we confirm that POD24 status is strongly associated with subsequent OS in MCL. Rituximab maintenance provided significant protection against the risk of POD24, independent of ASCT. Progression within 2 years should be considered as a primary endpoint in future studies.
 

摘要翻译： 

在套细胞淋巴瘤中，早期疾病进展与较短的总生存期相关。临床、病理和治疗策略对早期复发风险的影响尚未在大型患者队列中得到评估。我们对法国六项一线MCL随机试验中招募的患者进行了汇总分析。在1386例接受治疗的MCL患者中，1280例可评估POD24状态：其中299例（23.4%）发生POD24事件，981例（76.6%）未发生。发生POD24事件的患者中位总生存期为9.3个月（95% CI 8.4–11.8），而未发生POD24事件的患者尚未达到中位总生存期（95% CI 97.8–NR）。晚期复发患者的中位复发后总生存期也显著更长，为49.4个月（HR=0.39；95% CI 0.31–0.48；P<0.001），与POD24患者相比。基线变量（年龄、体能状态、B症状、LDH/ULN、白细胞计数、母细胞样变异型以及Ki-67>30%）与POD24风险显著相关，且独立于ASCT。在诱导治疗结束时有应答并接受ASCT的患者（n=1105）中，抗CD20维持治疗与POD24风险降低相关（OR=0.37；95% CI 0.1–1.0）。通过这项临床试验中的大型数据集，我们证实POD24状态与MCL后续总生存期密切相关。利妥昔单抗维持治疗对POD24风险具有显著保护作用，且独立于ASCT。未来研究中应将2年内疾病进展视为主要终点。

原文链接：

Validation of POD24 as a robust early clinical indicator of poor survival in mantle cell lymphoma from 1280 patients on clinical trials, a LYSA study