原发性纵隔 B 细胞淋巴瘤省略放射治疗：IELSG37 试验结果。
Omission of Radiotherapy in Primary Mediastinal B-Cell Lymphoma: IELSG37 Trial Results.
发表日期：2024 Aug 19
作者：
Maurizio Martelli, Luca Ceriani, Giovannino Ciccone, Umberto Ricardi, Iryna Kriachok, Barbara Botto, Monica Balzarotti, Alessandra Tucci, Sara Veronica Usai, Vittorio Ruggero Zilioli, Elsa Pennese, Luca Arcaini, Anna Dabrowska-Iwanicka, Andrés Jm Ferreri, Francesco Merli, Weili Zhao, Luigi Rigacci, Claudia Cellini, David Hodgson, Codruta Ionescu, Carla Minoia, Elisa Lucchini, Michele Spina, Alexander Fosså, Andrea Janikova, Kate Cwynarski, George Mikhaeel, Mats Jerkeman, Alice Di Rocco, Yana Stepanishyna, Umberto Vitolo, Armando Santoro, Alessandro Re, Benedetta Puccini, Jacopo Olivieri, Luigi Petrucci, Sally F Barrington, Bogdan Malkowski, Ur Metser, Annibale Versari, Stephane Chauvie, Jan Walewski, Marek Trneny, Franco Cavalli, Mary Gospodarowicz, Peter Wm Johnson, Andrew Davies, Emanuele Zucca,
来源：
MOLECULAR & CELLULAR PROTEOMICS
摘要：
巩固放疗在原发性纵隔B细胞淋巴瘤（PMBCL）患者中的作用存在争议。IELSG37试验是一项随机非劣效性研究，旨在评估诱导后具有完全代谢反应（CMR）的PMBCL患者是否可以省略放疗免疫化疗。主要终点是随机分组后 30 个月的无进展生存期 (PFS)。 CMR 患者被随机分配接受观察或巩固放疗（30 Gy）。非劣效性边际为 10%（假设双臂 30 个月的 PFS 均为 85%），计划样本量为 540 名患者，其中 376 名患者预计将被随机分组。观察到的事件大大低于预期，因此，当≥95%的患者随访≥30个月时进行主要终点分析。在 545 名入组患者中，268 名患者在诱导后接受 CMR，并随机接受观察组 (n=132) 或放疗组 (n=136)。观察组的 30 个月 PFS 为 96.2%，放疗组为 98.5%，分层风险比为 1.47（95%CI，0.34 至 6.28），绝对风险差为 0.68%（95%CI，-0.97） % 至 7.46%）。双臂的 5 年总生存率为 99%。非随机患者根据当地政策进行管理。对于 86% 的 Deauville 评分 (DS) 4 级患者和 57% 的 DS 5 级患者，放射治疗是唯一的治疗方法。DS 4 级患者的 5 年 PFS 和 OS（分别为 95.8% 和 97.5%）未达到预期目标。与随机分组的患者有显着差异。 DS5 患者的 5 年 PFS 和 OS 显着较差（分别为 60.3% 和 74.6%）。这项研究是 PMBCL 放疗的最大随机试验，证明在实现 CMR 的患者中具有良好的结果，而对于那些省略放疗的患者，没有生存损害。
The role of consolidation radiotherapy in primary mediastinal B-cell lymphoma (PMBCL) patients is controversial.The IELSG37 trial, a randomized non-inferiority study, aimed to assess whether irradiation can be omitted in PMBCL patients with complete metabolic response (CMR) after induction immunochemotherapy. Primary endpoint was progression-free survival (PFS) at 30 months post-randomization. Patients with CMR were randomly assigned to observation or consolidation radiotherapy (30 Gy). With a non-inferiority margin of 10% (assuming a 30-month PFS of 85% in both arms), a sample size of 540 patients was planned with 376 expected to be randomized.The observed events were considerably lower than expected, therefore, primary endpoint analysis was conducted when ≥95% of patients were followed for ≥30 months. Of 545 patients enrolled, 268 were in CMR after induction and were randomized to observation (n=132) or radiotherapy (n=136). The 30-month PFS was 96.2% in the observation arm and 98.5% in the radiotherapy arm, with a stratified hazard ratio of 1.47 (95%CI, 0.34 to 6.28) and absolute risk difference of 0.68% (95%CI, -0.97% to 7.46%). The 5-year overall survival was 99% in both arms.Non-randomized patients were managed according to local policies. Radiotherapy was the only treatment in 86% of those with Deauville score (DS) 4 and in 57% of those with DS 5. The 5-year PFS and OS of patients with DS 4 (95.8% and 97.5%, respectively) were not significantly different from those of randomized patients. Patients with DS5 had significantly poorer 5-year PFS and OS (60.3% and 74.6%, respectively).This study, the largest randomized trial of radiotherapy in PMBCL, demonstrated favorable outcomes in patients achieving CMR with no survival impairment for those omitting irradiation.