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复发/难治性原发性纵隔 B 细胞淋巴瘤中检查点抑制剂的真实世界多中心研究

英文原题:A Real-Life Multicenter Study of Checkpoint Inhibitors in Relapsed/Refractory Primary Mediastinal B-Cell Lymphoma.

查看英文原题

A Real-Life Multicenter Study of Checkpoint Inhibitors in Relapsed/Refractory Primary Mediastinal B-Cell Lymphoma.

PubMed 2026/04/10(内容时间) Am J Hematol Q1 · IF 9.4(JCR 2025)

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中文摘要

免疫检查点抑制剂(ICIs)的使用已深刻改善了复发/难治性(R/R)原发纵隔B细胞淋巴瘤(PMBCL)患者的结局。然而,真实世界数据仍然有限,包括巩固治疗策略的必要性在内的若干方面仍有待充分阐明。

我们报告了意大利多中心回顾性观察性PRIMICI研究的结果,该研究针对在真实世界(超说明书)环境下接受ICIs治疗的R/R PMBCL患者。共纳入74例患者,42例接受pembrolizumab治疗,32例接受nivolumab-brentuximab vedotin(nivo-BV)治疗。中位随访时间为34个月。最佳总体缓解率和完全缓解(CR)率分别为64%(n = 50)和50%(n = 37)。在37例达到CR的患者中,11例接受了巩固治疗,26例继续接受ICIs;CR保持稳定,与是否使用巩固治疗无关,4年无病生存率为100%。估计的5年无进展生存期(PFS)率和总生存期(OS)率分别为60.4%(95% CI 48.3%-70.6%)和77.5%(95% CI 65.8%-85.6%)。与pembrolizumab相比,nivo-BV与更快、更高的缓解率以及更好的OS相关。由于使用了CAR-T 细胞挽救治疗,2020年后OS显著改善。

总之,本研究支持pembrolizumab或nivo-BV作为R/R PMBCL患者挽救治疗的安全性和有效性。重要的是,无论是否使用巩固治疗均有机会获得持久缓解,这表明ICIs可在相当一部分患者中以治愈性意图使用。

展开英文摘要原文

The use of immune checkpoint inhibitors (ICIs) has deeply improved the outcome of relapsed or refractory (R/R) primary mediastinal B-cell lymphoma (PMBCL) patients.

However, real-world data are still limited, and several aspects, including the need for consolidation strategies, remain to be fully elucidated.

We report the results of the multicenter Italian retrospective observational PRIMICI study on R/R PMBCL patients treated with ICIs in a real-life (off-label) setting. Seventy-four patients, 42 treated with pembrolizumab and 32 with nivolumab-brentuximab vedotin (nivo-BV), were enrolled. The median follow-up was 34 months. The best overall response and complete response (CR) rates were 64% (n = 50) and 50% (n = 37), respectively.

Of the 37 patients in CR, 11 received a consolidation treatment and 26 patients continued ICIs; CR were stable, independently from the use of consolidation, with a 4-year disease-free survival of 100%. The estimated 5-year progression-free survival (PFS) and overall survival (OS) were 60.

4% (95% confidence interval [C. I.] 48. 3%-70. 6%) and 77. 5% (95% C. I. 65. 8%-85. 6%), respectively. Nivo-BV was associated with faster and higher response rates and better OS compared to pembrolizumab. OS significantly improved after 2020 due to the use of salvage treatment with CAR T-cells.

In conclusion, this study supported the safety and effectiveness of pembrolizumab or nivo-BV as a salvage therapy in R/R PMBCL patients.

Importantly, the chance to obtain long-lasting responses, regardless of the use of a consolidation treatment, indicates that ICIs may be used with a curative intent in a significant subset of patients.

论文信息

作者
Gugliotta G、Argnani L、Cantelli M、Pinto A、Gorgone A、Piazza F、Fozza C、Fesce VF
单位
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia "Seràgnoli", Bologna, Italy.Italy
文献类型
多中心研究 · 观察性研究
期刊
American journal of hematology2026 Jul
原文标识
PubMed 41960655 · DOI 10.1002/ajh.70317