Real-World Outcomes of Polatuzumab Vedotin Plus R-CHP Versus R-CHOP-Based Regimens in Japanese Patients With Untreated Diffuse Large B-Cell Lymphoma.

BACKGROUND: PV-R-CHP (polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone) is a recently introduced regimen for untreated diffuse large B-cell lymphoma (DLBCL). However, real-world data comparing its efficacy and safety with those of R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) remain limited. AIMS: This study aimed to evaluate the real-world efficacy and safety of PV-R-CHP compared with R-CHOP-based regimens in patients with newly diagnosed DLBCL. MATERIALS AND METHODS: We conducted a retrospective analysis of patients with DLBCL who received PV-R-CHP or R-CHOP-based treatment as first-line therapy at Kansai Medical University Hospital between January 2020 and August 2023. The primary endpoint was progression-free survival (PFS). Other outcomes included overall survival (OS), treatment response, subgroup analyses, and adverse events. Propensity score matching was performed, and prespecified subgroup analyses were conducted in the matched cohort. RESULTS: A total of 153 patients were included: 53 received PV-R-CHP and 100 received R-CHOP. At 1 year, both PFS and OS were significantly higher in the PV-R-CHP group than in the R-CHOP group (PFS: 89.3% vs. 70.9%, hazard ratio [HR] 0.30 [95% confidence interval (CI): 0.12-0.78], p = 0.013; OS: 92.5% vs. 80.0%, HR 0.28 [95% CI: 0.08-0.95], p = 0.041). Complete response rates were comparable between the groups (81.1% vs. 76.0%, p = 0.543). In propensity score-matched analyses, PV-R-CHP was associated with improved PFS in patients with non-germinal center B-cell-like (non-GCB) DLBCL. The incidence of grade ≥ 3 adverse events was similar between the regimens, with lymphopenia being the most frequent toxicity. CONCLUSION: PV-R-CHP may offer improved survival outcomes compared with R-CHOP in newly diagnosed DLBCL, particularly in patients with non-GCB, with an acceptable safety profile in a real-world setting. Although longer follow-up is required to confirm durability, these findings support the use of PV-R-CHP as a frontline treatment option.