Background: Diffuse large B-cell lymphoma (DLBCL) is a clinically and molecularly heterogeneous subtype of non-Hodgkin lymphoma, accounting for approximately 30% to 40% of all non-Hodgkin lymphoma cases. Polatuzumab vedotin combined with R-CHP (Pola-R-CHP) has been approved as a novel first-line therapeutic regimen for DLBCL based on findings from the POLARIX trial. However, real-world evidence regarding its efficacy and safety remains limited. This study aimed to evaluate the clinical efficacy and tolerability of the Pola-R-CHP regimen in patients newly diagnosed with DLBCL.

Methods: Newly diagnosed DLBCL patients were retrospectively enrolled from 10 medical centers located in Northeast China between January 11, 2024, and May 17, 2025. The primary treatment regimen consisted of Pola-R-CHP. The primary endpoint was the overall response rate (ORR) at the end of treatment. Secondary endpoints included complete response rate (CRR), progression-free survival (PFS), median overall survival (OS), and disease control rate (DCR).

Results: At data cutoff (July 21, 2025), 48 patients were enrolled (median age 57y, range 45-66). Most had advanced disease: 64.6% Ann Arbor stage III/IV, 56.3% >2 extranodal sites, 66.7% Ki-67≥80%, 62.5% elevated LDH, 52.1% elevated β2M, and 39.6% CD5+, 29% with bulky disease and 29% double-expression. The overall ORR among all patients (N=48) was 85.42%, with a complete response (CR) rate of 45.83%. Among the 39 patients who completed six cycles of treatment, the ORR was 97.44%, with a CR rate of 51.28%. The median follow-up duration was 4.96 months (range: 1.37–18.17 months). Median progression-free survival (PFS), overall survival (OS), and duration of response (DOR) were not reached. The 1-year PFS and OS rates were 87.50% and 95.83%, respectively. Subgroup analyses revealed 1-year PFS and OS rates of 85.71% and 92.86%, respectively, in patients with bulky disease, compared to 88.24% and 97.06% in those without bulky disease. No statistically significant differences in PFS (P=0.70) or OS (P=0.84) were observed between the two groups. The most common reported hematological adverse events (AEs) were anemia (54.2%), lymphocyte count decreased (50%), neutropenia (43.8%), and thrombocytopenia (22.9%). Common non-hematological AEs included fatigue (47.9%), alopecia (43.8%), vomiting (43.8%), and infection (41.7%). Most AEs were grade 1-2. Grade 3/4 AEs included neutropenia (16.7%), infection (12.5%), and alopecia (12.5%). No new safety signals were identified.

Conclusions: The Pola-R-CHP regimen demonstrated promising clinical efficacy and acceptable safety in newly diagnosed DLBCL patients. Subgroup analyses showed comparable PFS and OS outcomes between patients with and without bulky disease, suggesting that the Pola-R-CHP regimen may mitigate the adverse prognostic impact of bulky disease. These findings support Pola-R-CHP as a valuable first-line option. Larger, longer-term studies are warranted for further validation.

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2025
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