Retreatment with Brentuximab Vedotin in Patients with Relapsed/Refractory CD30+ Malignancies: A Retrospective Medical Chart Review Study in Spain-The BELIEVE Study.

BACKGROUND/OBJECTIVES: Brentuximab vedotin (BV) has been shown to be effective in the treatment of classical Hodgkin's lymphoma (cHL), systemic anaplastic large cell lymphoma (sALCL), and CD30-positive cutaneous T-cell lymphoma (CTCL). This study aimed to evaluate the effectiveness and safety of BV retreatment in patients with relapsed/refractory cHL, sALCL, and CD30-positive CTCL.

METHODS

This multicenter, non-interventional, retrospective medical chart review study analyzed medical records from 43 patients retreated with BV in Spain. Patients were included if they had relapsed or refractory cHL, sALCL, or CD30-positive CTCL and were previously treated with BV. Demographic characteristics, disease stage, response to treatment, survival outcomes, and adverse events were analyzed.

RESULTS

The study population included 16 patients with cHL, 13 with sALCL, and 14 with CTCL. The majority were male (58.1%) with a mean age of 46.2 years and baseline ECOG scores of 0-1. Among cHL and sALCL patients, disease stage, according to the Ann Arbor classification, ranged from I to IVB, while in CTCL, EORTC clinical stages ranged from IA to IVB. The overall response rate to BV retreatment was 76.7%, with the highest response observed in sALCL (92.3%). Complete remission was achieved in 60.5% of patients. Median progression-free survival was 25.4 months, and overall survival reached 50 months. Treatment failure occurred in 37.2% of patients. BV was generally well tolerated, with peripheral neuropathy being the most frequently reported adverse event.

CONCLUSIONS

The BELIEVE study is the largest study to date demonstrating that retreatment with BV is an effective and well-tolerated option for patients with relapsed or refractory CD30-positive malignancies.