Background Unfit patients with diffuse large B-cell lymphoma (DLBCL) often exhibit poor tolerance to intensive chemotherapy, necessitating alternative therapeutic strategies. This real-world study explored the efficacy and safety of programmed cell death protein 1 (PD-1) inhibitor (e.g., tislelizumab) combined with CD20 monoclonal antibody (e.g., rituximab) in this population.

Methods This retrospective cohort study analyzed 7 consecutive adult patients with histologically confirmed diffuse large B-cell lymphoma (DLBCL) who were deemed unfit for standard intensive chemotherapy (Colorectal Cancer Intrinsic Subtypes, CRIS Scoring ≥6, ECOG performance status ≥2, or major organ dysfunction). All patients received PD-1 inhibitor (pembrolizumab 200 mg intravenously every 3 weeks) combined with CD20 monoclonal antibody (rituximab 375 mg/m² intravenously every 3 weeks) at our institution between January 1, 2023, and December 30, 2024. Treatment response was evaluated using Lugano criteria, with progression-free survival (PFS) and overall survival (OS) calculated via Kaplan-Meier analysis. Safety profiles were graded by CTCAE v5.0.

Results This real-world pilot study evaluated PD-1/CD20 dual-target therapy in 7 unfit DLBCL patients (median age: 70 years; 85.7% female). Baseline biomarker analysis showed a median CRIS score of 7.0 (96% CI: 6.0–9.0), with notably elevated PD-L1 expression (median CPS: 80; range: 0–90; 71.4% with CPS ≥80). Patients received a median cumulative PD-1 inhibitor dose of 2200 mg (95% CI: 1200–2800 mg) over 251 days (95% CI: 121–576 days), achieving an 85.7% objective response rate (5 complete responses, 1 partial response). A single progression event occurred in a patient with PD-L1 CPS of 0, preventing median PFS estimation. All patients remained alive at the February 28, 2025, data cutoff, with median OS undefined. Safety analysis revealed hematologic toxicities (28.6% grade 2, 28.6% grade 3, 14.3% grade 4) and grade 1 hepatic abnormalities (14.3%), all managed supportively without treatment-related mortality.

Conclusion PD-1/CD20 dual-target therapy demonstrated promising efficacy (85.7% response rate) and manageable safety in unfit DLBCL, patients, highlighting its potential as a chemotherapy-sparing regimen. Larger prospective studies are warranted to validate these findings.

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2025
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