A Real-World Data-Based Analysis of Prognostic Indices as Part of Trial Eligibility Criteria in Diffuse Large B-Cell Lymphoma Patients

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*

*Corresponding author for this work

Research output: Contribution to journalJournal articleResearchpeer-review

Abstract

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.

Original languageEnglish
Book seriesEuropean Journal of Haematology
Number of pages11
ISSN0902-4441
DOIs
Publication statusE-pub ahead of print - 2024

Bibliographical note

Publisher Copyright:
© 2024 The Author(s). European Journal of Haematology published by John Wiley & Sons Ltd.

Keywords

  • clinical trial
  • diffuse large B cell lymphoma
  • prognostic models
  • selection criteria

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