A Prospective Study Comparing Treatment Outcomes of Brentuximab Vedotin Plus AVD versus ABVD in Egyptian Patients with Advanced Classical Hodgkin Lymphoma.
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BACKGROUND: Classical Hodgkin lymphoma (cHL) is a malignancy that is readily amenable to treatment, but still advanced-stage disease (stage III/IV) carries a significant therapeutic challenge. While ABVD (doxorubicin, bleomycin, vinblastine, dacarbazine) is a standard frontline regimen, its efficacy is limited by toxicity and relapse rates. Brentuximab Vedotin (BV), an anti-CD30 antibody-drug conjugate, concurrent with AVD (BV+AVD) has emerged as a promising alternative. This study compares the effectiveness and tolerability of BV+AVD versus ABVD in Egyptian patients with advanced cHL. METHODOLOGY: A prospective, randomized, open-label study was conducted at Helwan University Hospitals (March 2023-February 2025). A total of sixty patients with newly diagnosed stage III/IV cHL were randomized to receive either BV combined with AVD (BV+AVD; n = 30) or standard ABVD (n = 30). The primary endpoint was PFS, while secondary endpoints included PET negativity after two cycles, overall response rate (ORR), overall survival (OS), and treatment-related toxicity. RESULTS: Interim analysis demonstrated superior 2-year PFS for BV+AVD (80.0%) versus ABVD (53.3%). BV+AVD showed higher PET negativity rates post-cycle 2 (83.3% vs. 76.6%) and reduced pulmonary toxicity (6.7% vs. 23.3%). Hematologic toxicity (neutropenia: 60% vs. 40%) and neuropathy (43.3% vs. 16.7%) were more frequent with BV+AVD but mainly low grade and manageable. DISCUSSION: Limitations of this study encompass that it is a single-center study with a relatively small sample size that reduces the statistical power and makes it challenging to detect rare side effects. The population of the study represents the young and middle age group of patients with cHL so the treatment effect on older population was not studied. The limited follow-up duration restricts further knowledge about late relapses or delayed toxicities. CONCLUSION: BV+AVD significantly improves PFS and reduces bleomycin-associated toxicity, supporting its adoption as a frontline regimen for advanced cHL. Extended follow-up is required to validate the observed survival benefits.