Abstract Background Polatuzumab vedotin, an antibody-drug conjugate targeting CD79b, has become the standard of care (SOC) for both treatment-naive (TN) and relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) patients, administered via the Pola-R-CHP (rituximab, cyclophosphamide, doxorubicin, prednisone) and Pola-BR (bendamustine plus rituximab) regimens. Unlike the strict inclusion criteria of clinical trials, real-world patients often present with poorer baseline conditions and higher disease burdens, with treatment modalities individualized based on their disease characteristics. Thus, evaluating the efficacy and safety of Pola-based regimens in real-world settings is of critical importance. Based on this, we retrospectively analyzed consecutive patients treated with Pola-based regimens at our center to investigate their disease characteristics, treatment patterns, and clinical outcomes. Methods This retrospective study enrolled consecutive patients from Changhai Hospital Affiliated to Naval Military Medical University who received Pola-based regimens. Efficacy was evaluated via whole-body 18F-FDG PET/CT or contrast-enhanced CT scans during and after treatment. Some patients were considered for autologous stem cell transplantation (ASCT) as consolidation therapy. Treatment responses were assessed using the 2014 Lugano criteria, and adverse events (AEs) were graded according to the NCI-CTCAE v5.0. Efficacy endpoints included complete response (CR) rate, objective response rate (ORR), safety profile, progression-free survival (PFS), and overall survival (OS). Results A total of 30 patients were enrolled between October 2024 and August 2025. The overall baseline characteristics indicated a high-risk profile: median age was 68.5 years (range, 46–81 years); 4 patients (13.3%) had transformed follicular lymphoma (tFL), and 2 (6.7%) had T-cell/histiocyte-rich large B-cell lymphoma (THRLBCL). Twenty-four patients (80.0%) were staged Ann-Arbor III–IV, and 16 (53.3%) were classified as high-risk by the International Prognostic Index (IPI). Additional high-risk factors included extranodal involvement (25 patients, 83.3%), double-expressor lymphoma (DEL, 17 patients, 56.7%), double-hit/triple-hit lymphoma (DH/TH, 5 patients, 16.7%), and high P53 expression (11 patients, 36.7%). Regarding treatment history: 14 patients (46.7%) were previously untreated, and 16 (53.3%) had received at least one prior line of therapy. Among the latter, 5 had early relapse after their last treatment, 6 were refractory, and 1 had prior exposure to ASCT and chimeric antigen receptor T-cell therapy (CAR-T). To date, the median number of Pola-based regimen cycles administered was 2 (range, 1–6). Ten patients were evaluable for efficacy, with 5 achieving CR and 3 achieving partial response (PR); 3 patients (10%) proceeded to ASCT afterward. In this high-risk population, Pola-based regimens showed manageable toxicity, with 37.5% of patients experiencing grade 3–4 AEs. The most common AEs were anemia (100.0%), decreased white blood cell count (41.7%), and decreased neutrophil count (41.7%), most of which were grade 1–2. The most frequent grade 3–4 AE was anemia (25.0%). With a median follow-up of 3.8 months (95% CI: 5.7–8.9), only 2 patients progressed: one was CD5-positive, and the other had high P53 expression. Conclusion Our results characterize the real-world disease features, treatment patterns, and outcomes of DLBCL patients with high-risk prognostic factors, treated with Pola-based regimens. Even in this high-risk population, Pola-based therapy demonstrated promising efficacy and manageable toxicity. However, detailed data on response rates and survival outcomes require further reporting following extended follow-up.
Miaomiao Liu (Mon,) studied this question.
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