Background: DLBCL is the most common subtype of non-Hodgkin lymphoma. After first-line curative intent therapy, approximately 40% of patients will develop R/R DLBCL.​ For eligible patients, both autologous stem cell transplant (ASCT) and chimeric antigen receptor T cell (CAR-T) therapy have curative potential as 2L treatment. However, not all patients are suitable for ASCT or CAR-T therapy. Gemcitabine-oxaliplatin plus rituximab (R-GemOx) is a common regimen that is well-tolerated in older adults with other comorbidities, for whom treatment of DLBCL is challenging and has inferior outcomes. This real-world retrospective study examines the clinical characteristics and outcomes of patients receiving 2L therapy for R/R DLBCL, stratified by stem cell transplant status and with a subgroup analysis of R-GemOx treatment without stem cell transplant, in the community oncology setting.

Methods: Data were abstracted from the iKnowMed electronic health records of adult patients diagnosed with R/R DLBCL and treated with 2L therapies within the US Oncology Network from 1/1/2016 to 12/31/2023 and followed through 9/30/2024. Targeted chart abstraction was performed to assessphysician-documented tumor response and progression information. Patient characteristics were assessed overall, by transplant status (receipt of ASCT vs. no receipt of ASCT), and for a subgroup of non-ASCT patients who received R-GemOx. Real-world response rate (rwRR) was evaluated as the proportion of patients with complete (CR) or partial response (PR) after 2L initiation among all patients. The following outcomes were assessed overall and by subgroup, using Kaplan-Meier methods: real-world time-to-next-treatment (rwTTNT), real-world progression-free survival (rwPFS), and real-world overall survival (rwOS).

Results: Of 400 eligible patients with R/R DLBCL who received 2L therapies, 334 (83.5%) were non-ASCT treated patients and 66 (16.5%) were ASCT treated patients. The 2L R-GemOx treatment accounted for 10.2% (n=34) of the non-ASCT treated group.​ Overall, 16.0% (64/400) patients received CAR-T after initiating a 2L treatment, including 15.2% (10/66) ASCT patients and 16.2% (54/334) non-ASCT patients; there were 26.5% (9/34) patients who received CAR-T in the R-GemOx subgroup. Only 23 (34.8%) patients in the ASCT treated group were 65 or older at diagnosis, while 71.6% (n=239) of non-ASCT treated patients and 73.5% (n=25) of the R-GemOx patients were 65 or older. A higher proportion of patients had Eastern Cooperative Oncology Group (ECOG) performance scores of 2+ in the R-GemOx subgroup (n=8, 23.5%) than the ASCT (n=6, 9.1%) and non-ASCT (n=57, 17.1%) groups. The most common 2L treatment regimens were rituximab, ifosfamide, carboplatin, plus etoposide in ASCT (n=41, 62.1%) and bendamustine plus rituximab (n=62, 18.6%) in non-ASCT treated groups. Progression was the most common reason for treatment discontinuation in the overall population (n=110, 27.5%), and highest in the non-ASCT (n=110, 32.9%) and R-GemOx (n=14, 41.2%) subgroups. All ASCT treated patients achieved a CR (n=57, 86.4%) or PR (n=9, 13.6%), while rwRR was 63% in non-ASCT group and 56% in the R-GemOx subgroup. ASCT treated patients had a median rwPFS of 32.8 months (95% CI: 16.6, not reached) with rwTTNT and rwOS that were not reached within the observation period. Non-ASCT patients had a median rwPFS of 4.7 months (95% CI: 4.1, 5.6), a median rwTTNT of 8.0 months (95% CI: 6.3, 10.5), and a median rwOS of 15.6 months (95% CI: 11.9, 22.2). Patients in the R-GemOx subgroup had a median rwPFS of 2.4 months (95% CI: 1.6, 7.4), a median rwTTNT of 4.1 months (95% CI: 2.0, 7.4), and a median rwOS of 11.9 months (95% CI: 5.7, 41.6). Survival probability at 2–years was 78.2% (95% CI: 65.3%, 86.8%) in the ASCT group, 43.1% (95% CI: 36.8%, 49.3%) in the non-ASCT group, and 40.9% (95% CI: 21.7%, 59.3%) in the R-GemOx subgroup. ​Conclusions: The majority of 2L treated patients with R/R DLBCL in the real-world community oncology setting did not receive ASCT or CAR-T, and R-GemOx was a more common 2L regimen among these patients. A higher percentage of patients in the non-ASCT treated group, specifically in the R-GemOx subgroup, were older with higher ECOG scores and inferior treatment related outcomes, including a minority alive at 2 years. These findings highlight a continuing unmet need for more effective, safer treatments for patients with R/R DLBCL ineligible for or unable to access ASCT or CAR-T.

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2025
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