Real-World Effectiveness of R-miniCHOP versus R-Pola-miniCHOP in Elderly Patients with Newly Diagnosed LBCL – pooled results from the prospective German and Greek Lymphoma registries
Herr Dr. med. Konstantinos Christofyllakis
Konstantinos.Christofyllakis@uks.eu
Universität des Saarlandes - Homburg (Institution, 12033)
Klinik für Innere Medizin I
Geb. 41.1, Kirrberger Str. 100
66421 Homburg
| Beschreibung | Background and Rationale
Older or frail patients with diffuse large B-cell lymphoma (DLBCL) are commonly treated with R-miniCHOP. The substitution of vincristine with polatuzumab vedotin (R-Pola-miniCHP) may improve efficacy, as suggested by subgroup analyses from POLARIX showing greater benefit with increating age (Hu et al Blood Adv 2025). However, interim safety data from the prospective ongoing phase II POLAR-BEAR trial indicate higher toxicity and treatment-related mortality with R-pola-miniCHP compared to R-miniCHOP (6 vs 2 treatment related deaths) (Jerkerman et al EHA 2023). This real-world, retrospective, international registry study aims to evaluate the effectiveness and tolerability of R-Pola-miniCHOP compared with R-miniCHOP in Germany and Greece. Objectives Primary Objective: To compare progression-free survival (PFS) between R-miniCHOP and R-Pola-miniCHP. Secondary Objectives: To compare overall survival (OS), treatment delivery, and safety outcomes Study Design Multicenter, retrospective, observational cohort study using national lymphoma registries in Germany and Greece. Approximately 60 patients treated with R-Pola-miniCHP and 240 patients treated with R-miniCHOP (diagnosis 2021–2025). | |
| Indikation | DLBCL | |
| Patientenpopulation | Approximately 60 patients treated with R-Pola-miniCHP and 240 patients treated with R-miniCHOP (diagnosis 2021–2025). | |
| Statistische Annahmen | Analyses will use propensity score (PS) matching (1:3–4) and inverse probability of treatment weighting (IPTW) to adjust for confounding (age, sex, ECOG, Charlson index, stage, IPI, LDH, country). Cox models will estimate hazard ratios with 95% CIs. With 60 vs 240 patients and 70% event rate, power ≈54% to detect HR=0.70. | |
| Primäre Endpunkte | Primary endpoint: PFS. | |
| Sekundäre Endpunkte | Secondary: OS, safety, treatment delivery | |
| Geplante Projektdauer (Projektstart, Projektende) | 08/2026- 08/2027 | |
| Projekt finanziert durch | keine Finanzierung, Anfrage bei Roche vorgesehen aber nicht erfolgsversprechend | |
| Biometrische Analyse | Datenexport und eigene Analyse | |
| Ist eine Erweiterung des Datensatzes projektspezifisch notwendig? | Nein | |
| Ist eine direkte Interaktion (über die Vertrauenstelle) mit den Patienten geplant? | Nein | |
