Relapsed/refractory diffuse large B-cell lymphoma patients. A multicenter retrospective analysis of eligibility criteria for car-T cell therapy

Abstract

Anti-CD19 chimeric antigen receptor (CAR) T cells represent the first approved third-line therapy associated with long-term remissions in patients with refractory/relapsed (R/R) diffuse large B-cell lymphoma (DLBCL). Eligibility criteria to identify patients who can successfully receive CAR-T are still debated. For this reason, the aim of this study was to identify factors influencing eligibility and define a realistic patient estimate. Of 1100 DLBCL patients, 137 were included. Based on the Juliet trial inclusion criteria, only 64 patients (46.7%) would be eligible. Median overall survival (OS) was 8.04 months in eligible vs 3.23 in non-eligible patients (p < 0.001). Multivariate analysis identified stage III-IV (p = 0.017) and ECOG $\ge$2 (p < 0.001) as significant independent prognostic factors for OS. Moreover, only 64/1100 (5.8%) DLBCL patients would be truly eligible for CAR-T. Our real-life data confirm that with a$\mathrm{ }$ longer waiting time patients with advanced stage and poor ECOG are less likely to be eligible for CAR-T cell infusion.

Keywords:

• Diffuse large B-cell lymphoma
• CAR-T cells
• relapse-refractory disease
• CAR-T cell eligibility

Acknowledgments

ADR designed and performed the research, analyzed data and wrote the paper. LP, DP, FR, MG provided samples and clinical data; MA and GDL analyzed the data and wrote the paper. GMR, FR, FM critically revised the paper. AF designed the research study and ADR performed statistical analysis. AC and RF supervised the study and critically revised the manuscript.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Correction Statement

This article has been republished with minor changes. These changes do not impact the academic content of the article.

Additional information

Funding

This work was partly supported by Associazione Italiana per la Ricerca sul Cancro (AIRC) 5 × 1000, Special Program Metastases (21198), Milan (Italy), to RF and BEAT Leukemia to AC.