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2000年至2017年GITMO关于≥60岁患者同种异体移植的登记研究:进展与批评

GITMO Registry Study on Allogeneic Transplantation in Patients Aged ≥60 Years from 2000 to 2017: Improvements and Criticisms.

作者信息

Malagola Michele, Polverelli Nicola, Rubini Vicky, Martino Massimo, Patriarca Francesca, Bruno Benedetto, Giaccone Luisa, Grillo Giovanni, Bramanti Stefania, Bernasconi Paolo, De Gobbi Marco, Natale Annalisa, Terruzzi Elisabetta, Olivieri Attilio, Chiusolo Patrizia, Carella Angelo Michele, Casini Marco, Nozzoli Chiara, Mazza Patrizio, Bassi Simona, Onida Francesco, Vacca Adriana, Falcioni Sadia, Luppi Mario, Iori Anna Paola, Pavone Vincenzo, Skert Cristina, Carluccio Paola, Borghero Carlo, Proia Anna, Selleri Carmine, Sacchi Nicoletta, Mammoliti Sonia, Oldani Elena, Ciceri Fabio, Russo Domenico, Bonifazi Francesca

机构信息

Blood Diseases and Cell Therapies Unit, Bone Marrow Transplant Unit, "ASST-Spedali Civili" Hospital of Brescia; Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy.

Blood Diseases and Cell Therapies Unit, Bone Marrow Transplant Unit, "ASST-Spedali Civili" Hospital of Brescia; Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy.

出版信息

Transplant Cell Ther. 2022 Feb;28(2):96.e1-96.e11. doi: 10.1016/j.jtct.2021.11.006. Epub 2021 Nov 21.

Abstract

Today, allogeneic stem cell transplantation (allo-SCT) can be offered to patients up to age 70 to 72 years and represents one of the most effective curative treatments for many hematologic malignancies. The primary objective of the study was to collect data from the allo-SCTs performed in Italy between 2000 and 2017 in patients aged ≥60 years to evaluate the changes in safety and efficacy outcomes, as well as their distribution and characteristics over time. The Italian Group for Bone Marrow Transplantation, Hematopoietic Stem Cells and Cell Therapy (GITMO) AlloEld study (ClinicalTrials.gov identifier NCT04469985) is a retrospective analysis of allo-SCTs performed at 30 Italian transplantation centers in older patients (age ≥60 years) between 2000 and 2017 (n = 1996). For the purpose of this analysis, patients were grouped into 3 time periods: time A, 2000 to 2005 (n = 256; 12%); time B, 2006 to 2011 (n = 584; 29%); and time C, 2012 to 2017 (n = 1156; 59%). After a median follow-up of 5.6 years, the 5-year nonrelapse mortality (NRM) remained stable (time A, 32.8%; time B, 36.2%; and time C, 35.0%; P = .5), overall survival improved (time A, 28.4%; time B, 31.8%; and time C, 37.3%; P = .012), and the cumulative incidence of relapse was reduced (time A, 45.3%; time B, 38.2%; time C, 30.0%; P < .0001). The 2-year incidence of extensive chronic graft-versus-host disease was reduced significantly (time A, 17.2%; time B, 15.8%; time C, 12.2%; P = .004). Considering times A and B together (2000 to 2011), the 2-year NRM was positively correlated with the Hematopoietic Cell Transplantation Comorbidity Index (HCT-CI) score; NRM was 25.2% in patients with an HCT-CI score of 0, 33.9% in those with a score of 1 or 2, and 36.1% in those with a score of 3 (P < .001). However, after 2012, the HCT-CI score was not significantly predictive of NRM. This study shows that the transplantation procedure in elderly patients became more effective over time. Relapse incidence remains the major problem, and strategies to prevent it are currently under investigation (eg, post-transplantation maintenance). The selection of patients aged ≥60 could be improved by combining HCT-CI and frailty assessment to better predict NRM.

摘要

如今,异基因干细胞移植(allo - SCT)可用于70至72岁的患者,是许多血液系统恶性肿瘤最有效的治愈性治疗方法之一。该研究的主要目的是收集2000年至2017年期间在意大利对年龄≥60岁的患者进行allo - SCT的数据,以评估安全性和疗效结果的变化,以及它们随时间的分布和特征。意大利骨髓移植、造血干细胞和细胞治疗组(GITMO)的AlloEld研究(ClinicalTrials.gov标识符NCT04469985)是对2000年至2017年期间在意大利30个移植中心对老年患者(年龄≥60岁)进行的allo - SCT的回顾性分析(n = 1996)。为了进行此次分析,患者被分为3个时间段:时间段A,2000年至2005年(n = 256;12%);时间段B,2年发病率显著降低(时间段A,17.2%;时间段B,15.8%;时间段C,12.2%;P = 0.004)。将时间段A和B合并(2此研究表明,老年患者的移植手术随着时间推移变得更有效。复发率仍然是主要问题,目前正在研究预防复发的策略(例如,移植后维持治疗)。通过结合造血细胞移植合并症指数(HCT - CI)和衰弱评估来更好地预测非复发死亡率,可能会改善对年龄≥60岁患者的选择。 2006年至2011年(n = 584;29%);时间段C,2012年至2017年(n = 1156;59%)。中位随访5.6年后,5年非复发死亡率(NRM)保持稳定(时间段A,32.8%;时间段B,36.2%;时间段C,35.0%;P = 0.5),总生存率有所提高(时间段A,28.4%;时间段B,31.8%;时间段C,37.3%;P = 0.012),复发累积发生率降低(时间段A,45.3%;时间段B,38.2%;时间段C,30.0%;P < 0.0001)。广泛性慢性移植物抗宿主病的0,NRM为25.2%;评分为1或2的患者中为33.9%;评分为3的患者中为36.1%(P < 0.001)。然而,2012年后,HCT - CI评分对NRM的预测并不显著。

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