Abstract
Introduction. Historically, R-CHOP regimen has been the standard first line treatment for diffuse large B-cell lymphoma (DLBCL). The introduction of polatuzumab vedotin in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (POLA-R-CHP) has shown a progression-free survival benefit in the POLARIX trial, particularly among patients with high IPI score. However, real-world data on efficacy and toxicity profile of this combination regimen remain limited.
Methods. A retrospective analysis was conducted on 36 patients diagnosed with DLBCL and treated with the POLA-R-CHP regimen at four Hematology Centers between January 2024 and September 2025. For each patient, demographic, clinical-biological, and therapeutic data were collected, including age, sex, ECOG performance status, stage, IPI, histologic subtype, metabolic response (interim and end of treatment PET CT scan), toxicity (≥ grade III hematologic and non-hematologic), relapse events, and vital status at last follow-up.
Results. The median age at diagnosis was 67 years (range 26–84); 28 patients (77%) were male. Advanced stages (III–IV) were predominant (71%), with a mean IPI of 3. The most frequent subtype was ABC (activated B-cell-like). At the end of treatment, 26 patients (72%) achieved complete response (CR), 6 partial response (PR), and 4 (8%) had progressive disease. Three relapses occurred during the observation period; 2 of these patients received CAR-T therapy as second-line treatment, and 1 developed CNS relapse. There were 4 deaths (8%): one due to thromboembolic toxicity, one to sepsis, and two related to disease progression. The estimated 1-year PFS (28/36) was 74.1% (95% CI 57.5–90.6). The most common ≥ grade III toxicity was neutropenia. No grade III/IV neuropathy or other polatuzumab-related severe toxicity was observed.
Conclusions. POLA-R-CHP regimen proved to be effective and well tolerated, even in elderly and comorbid patients. The high complete response rate and 1-year PFS support the robustness of the POLARIX trial results in a real-world setting. The favorable tolerability profile of polatuzumab was confirmed. Longer follow-up and larger cohorts are warranted to assess response durability and to better characterize late-onset toxicities.
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