Introduction

Despite the improvement in management of diffuse large B-cell lymphoma (DLBCL) in recent years, the outcome of patients in low and low-middle income countries remains suboptimal. Moreover, clinical presentation, treatment patterns, and long-term outcomes in Brazil, as well as in Latin America, remain poorly understood. Considering the heterogeneous population and the lack of access to novel therapies, there is a clear need to understand the outcome of these patients in the real world.Methods

BRA-DLBCL is a Brazilian multicenter retrospective observational study aiming to generate real-world data (RWD) in patients with newly diagnosed DLBCL. The primary objective of this study is to describe the epidemiological profile of DLBCL and the survival outcomes of patients registered from 2017 to 2023 in centers located in the southeast and northeast regions of Brazil, which encompass more than two-thirds of the Brazilian population. The cell of origin was classified by immunohistochemistry using Hans algorithm and classified into germinal center B-cell-like DLBCL (GCB) or non-GCB. The primary outcome was progression-free survival (PFS). Secondary outcomes were overall survival (OS), progression rate, and non-relapse mortality. Univariable analyses were carried out with Kaplan-Meier and cumulative incidence curves, and compared with logrank and Gray tests, respectively. Multivariable analyses were performed only for the primary outcome, using Cox model, selected based on the lowest AIC. BRA-DLBCL was funded by AstraZeneca.Results

We included 532 patients with a median follow-up of 40 months. Of those, 275 were classified as GCB and 257 as non-GCB. The median age was 65 years, and 46% were females. Baseline patient profiles were well-balanced, except for a slightly higher prevalence of B symptoms in the non-GCB group (62% vs 54%). The median Ki-67 was 90%. Most patients were treated with R-CHOP. Three-year progression-free survival was 67% (95CI 62-74%) in GBC (67%, 95CI 62-74%) and 51% (95CI 45-58%, p<0.001) in non-GBC. Three-year overall survival was also significantly higher in GBC (72%, 95CI 67-78%) compared with non-GCB (66%, 95CI 60%-72%, p=0.044). Most of the difference in failures was attributed to a higher progression rate in the non-GCB group (37% vs. 25%, p=0.020). However, non-relapse mortality was also significantly higher in the non-GCB (12% vs. 8%, p=0.03).

In multivariable analysis for progression-free survival, the only factors associated with progression or death were non-CGB (HR=1.41, 95CI 1.03-1.93, p=0.03) and any extranodal involvement (HR=1.67, 95CI 1.10-2.53, p=0.02).Discussion

In this multicenter study of over 500 Brazilian patients, patients with non-GCB phenotypes had poorer progression-free survival, mainly due to higher progression rates. We also found, in multivariable analysis, that any extranodal involvement independently impairs progression-free survival. Incorporating novel treatments may attenuate these differences, and prospective studies in the developing countries scenario should clarify this hypothesis. An interesting finding was the small but higher non-relapse mortality in the non-GCB group. No baseline characteristic of the patients can explain the higher non-relapse mortality in the non-GCB group, and further studies are needed to address this issue.

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2025
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