基于真实世界数据的弥漫大 B 细胞淋巴瘤患者预后指标分析(作为试验资格标准的一部分

IF 2.3 3区 医学 Q2 HEMATOLOGY European Journal of Haematology Pub Date : 2024-09-10 DOI:10.1111/ejh.14301
Jelena Jelicic, Karen Juul-Jensen, Zoran Bukumiric, Mikkel Runason Simonsen, Michael Roost Clausen, Ahmed Ludvigsen Al-Mashhadi, Robert Schou Pedersen, Christian Bjørn Poulsen, Anne Ortved Gang, Peter Brown, Tarec Christoffer El-Galaly, Thomas Stauffer Larsen
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引用次数: 0

摘要

目的最近的一线临床试验使用国际预后指数(IPI)来确定新诊断的弥漫大B细胞淋巴瘤(DLBCL)患者是否符合试验条件。方法我们评估了国际预后指数对临床试验患者入组的影响,目的是根据POLARIX/EPCORE DLBCL-2试验标准排除低风险IPI患者。结果我们在丹麦淋巴瘤登记处发现了2877名患者,如果将IPI 0-1分的患者纳入其中,他们将符合POLARIX试验的条件。IPI和NCCN-IPI分别将33.3%和11.9%的患者归入低风险组。与 NCCN-IPI 低风险组相比,IPI 低风险组患者的 5 年总生存期更短(91.4% 对 97.5%),复发率更高(9.9% 对 4.4%),死亡人数更多(16.1% 对 4.4%)。分析模型未能识别出预后不良的真正高危患者。根据 EPCORE DLBCL-2 试验资格标准建立的确证队列中也发现了类似的结果。结论 NCCN-IPI 更好地识别了真正的低危患者,由于其预后极佳,应将其排除在一线临床试验之外。然而,在选择符合试验条件的患者时,除了临床预后模型外,还需要考虑其他高危因素。
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A Real-World Data-Based Analysis of Prognostic Indices as Part of Trial Eligibility Criteria in Diffuse Large B-Cell Lymphoma Patients

Objectives

Recent front-line clinical trials used the International Prognostic Index (IPI) to identify trial-eligible patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL). However, many IPI-like variants with improved accuracy have been developed over the years for rituximab-treated patients.

Methods

We assessed the impact of International Prognostic Indices on patient enrolment in clinical trials, aiming to exclude low-risk IPI patients based on POLARIX/EPCORE DLBCL-2 trial criteria.

Results

We identified 2877 patients in the Danish Lymphoma Registry who would have been eligible for the POLARIX trial if patients with IPI 0–1 scores were included. IPI and NCCN-IPI assigned 33.3% and 11.9% of patients to the low-risk group, respectively. Shorter 5-year overall survival (91.4% vs. 97.5%), higher relapse rate (9.9% vs. 4.4%), and more deaths (16.1% vs. 4.4%) occurred in the low-risk IPI group compared with low-risk NCCN-IPI group. Analyzed models failed to identify true high-risk patients with poor prognosis. Similar results were found in the confirmatory cohort developed based on EPCORE DLBCL-2 trial eligibility criteria.

Conclusion

True low-risk patients are more optimal identified by NCCN-IPI and should be excluded from front-line clinical trials due to their excellent prognosis. However, additional high-risk factors besides clinical prognostic models need to be considered when selecting trial-eligible patients.

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来源期刊
CiteScore
5.50
自引率
0.00%
发文量
168
审稿时长
4-8 weeks
期刊介绍: European Journal of Haematology is an international journal for communication of basic and clinical research in haematology. The journal welcomes manuscripts on molecular, cellular and clinical research on diseases of the blood, vascular and lymphatic tissue, and on basic molecular and cellular research related to normal development and function of the blood, vascular and lymphatic tissue. The journal also welcomes reviews on clinical haematology and basic research, case reports, and clinical pictures.
期刊最新文献
Issue Information Treatment of Refractory Monoclonal Immunoglobulin Deposition Disease With BCMA Bispecific Antibody. Avatrombopag for the Treatment of Immune Thrombocytopenia. Central Nervous System Involvement in Chronic Lymphocytic Leukemia: A Case-Series. Splenic Embolization in Refractory Immune Thrombocytopenia.
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