Initial experience with anti-CD19 CAR-T cell therapy in patients with Relapsed/Refractory diffuse large B-cell lymphoma in a brazilian cancer center
Year: 2025
Type: conference-abstract
Abstract: INTRODUCTION: Chimeric antigen receptor T-cell (CAR-T) therapy targeting CD19 has emerged as a promising therapeutic modality for patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL). Since the approval of axicabtagene ciloleucel (axi-cel) and tisagenlecleucel (tisa-cel) in Brazil in 2022, access to cellular therapies has significantly expanded. However, real-world data regarding their feasibility, outcomes, and associated toxicities remain limited. This study aims to describe the initial institutional experience with CAR-T cell therapy in patients with R/R DLBCL, comparing the two anti-CD19 products available in Brazil at the time. METHODS: Retrospective analysis of medical records from R/R DLBCL patients treated with tisa-cel or axi-cel at our institution (2022–2025). RESULTS: 23 patients were included, 11 treated with tisa-cel (47.8%) and 12 with axi-cel (52.2%). The median age was 56 (tisa-cel) and 52 (axi-cel), with a male predominance in both groups (14 vs 9 female). Functionality was assessed by ECOG: most axi-cel patients were ECOG 0 (91.7%), while tisa-cel patients were split between ECOG 0 and 1 (45.5% each). The main histology subtype was germinal center; few searched for double-hit mutations, with only 2 confirmed by FISH in the tisa-cel group. Advanced stage disease (Ann Arbor III/IV) and elevated lactate dehydrogenase (median value:321 U/L; Upper Limit:227U/L) were similar between groups. Bulky disease was more common in patients submitted to tisa-cel (36,4% vs. 16,7% axi-cel). Most patients received ≥3 prior therapy lines, with 4 lines predominant in axi-cel (50%) and 3 in tisa-cel (45.5%). At infusion, progressive disease (PD) was more frequent in tisa-cel (81.1%), while partial response (PR) predominated in axi-cel (50%). Median brain-to-vein time was 109 days (tisa-cel) vs. 122 days (axi-cel). Hematologic toxicity risk (CARHEMATOTOX >2) was higher in the tisa-cel group, with 18.2% scoring 6. Infections were more frequent in the tisa-cel group (90.9% vs. 66.7%). ICU admission was similar (63.6%), but stays were longer with axi-cel (16 vs. 4 days). Intubation was also more common with axi-cel (25% vs. 9.1%). Grade 2 CRS predominated in both groups; grade 3 occurred only with tisa-cel. Tocilizumab use was similar. ICANS was more frequent with axi-cel (75%), leading to greater Anakinra use (50%), while 72% of tisa-cel patients had no ICANS. At day 30, 34% achieved CR (75% tisa-cel, 25% axi-cel), 13% PR (66% axi-cel, 34% tisa-cel), and 21% PD (40% tisa-cel, 60% axi-cel). At day 60, CR was 30% (57% tisa-cel, 43% axi-cel), 1 PR (axi-cel), and 30% PD (28% tisa-cel, 72% axi-cel). At day 180, 13% were in CR (66% tisa-cel, 34% axi-cel), 1 PR (axi-cel), and 17% (n=4) in PD—all axi-cel. There were 7 deaths: one at day 30 (axi-cel), one at day 60 (tisa-cel), and three at day 180 (2 tisa-cel, 1 axi-cel). Follow-up was unavailable for 20% at day 30, 8% at day 60, and 30% at day 180. CONCLUSION: This Brazilian real-world analysis demonstrates that both CAR-T products are feasible but differ in efficacy and toxicity. Tisa-cel showed superior early responses despite higher-risk disease, while axi-cel was associated with more neurologic toxicity and early mortality. However, it is important to highlight the limitations of our data, considering the small sample size, missing follow-up registries and the heterogeneity in baseline characteristics, precluding a robust comparative analysis between products. Finally, real-world challenges, such as the prolonged brain-to-vein time and high ICU utilization, underscore logistical and toxicity management hurdles in middle-income countries like Brazil.
Source: Blood
Authors: Bianca Cal, Breno Aires de Souza, Julia Ferreira Campos, Julia Aith Baltazar, Gioavanna Alves Peruzini, Matheus de Lima Garcia, Luciana Magalhães Brandão, Nina Maia Santana, Julia Curi Amarante, Arthur Gomes Oliveira Braga, Ana Cordeiro, Vanessa Bovolenta, Thais Rodrigues da Cunha Fischer, Talita Maira Bueno da Silveira, Marjorie Batista, Marina de Mattos Nascimento, Jayr Schmidt Filho
Language: English
Topic: CAR-T cell therapy research
Subfield: Oncology
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
OpenAlex ID: W7108458100
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