Abstract / Summary
Abstract Purpose Approximately 30% of newly diagnosed diffuse large B-cell lymphoma (DLBCL) cases are categorized as low-risk by the international prognostic index (IPI). Polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP) has demonstrated efficacy in untreated DLBCL with IPI score of 2–5, but its role in IPI 0–1 patients who harbor other adverse factors is unknown. We conducted a multicenter, real-world retrospective study to evaluate frontline Pola-R-CHP in DLBCL with IPI 0–1. Methods Between 10 June 2023 and 19 July 2025, previously untreated DLBCL patients receiving first-line Pola-R-CHP were enrolled across 17 Chinese hospitals. Whole-body [ 18 F]fluorodeoxyglucose PET/CT or contrast-enhanced CT was performed for efficacy evaluation after 3–4 cycles (interim) and at end of treatment (EOT). Responses were assessed per the Lugano classification, and adverse events were graded according to Common Terminology Criteria for Adverse Events version 5.0. The primary endpoint was the complete response (CR) rate at EOT; secondary endpoints included interim CR rate, overall response rate (ORR) at interim and EOT, safety, progression-free survival, and overall survival. Results A total of 118 consecutive previously untreated DLBCL patients were included. The median age was 53.5 years (range, 17–87 years). Fifteen (12.7%) had bulky diseases, 29 (24.6%) had double-expressor lymphoma (DEL), 11 (9.3%) had double-hit/triple-hit lymphoma, and 30 (25.4%) showed high P53 expression. The median number of Pola-R-CHP cycles was 6 (range, 1–8). At a median follow-up of 7.1 months, the EOT CR rate was 92.6%. Only 2 patients progressed, both with central nervous system involvement (at 7.5 and 5.7 months). Exploratory subgroup analyses showed broadly similar response rates across all subgroups at both interim and EOT. The most common grade 3–4 adverse event was decreased neutrophil count (21.2%). Conclusion Pola-R-CHP is an effective and tolerable frontline regimen for treatment-naïve DLBCL patients with IPI of 0–1, even among those with high risk factors.