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.
背景/目的：本妥昔单抗已被证实对经典型霍奇金淋巴瘤、系统性间变性大细胞淋巴瘤及CD30阳性皮肤T细胞淋巴瘤具有治疗效果。本研究旨在评估本妥昔单抗再治疗在复发/难治性经典型霍奇金淋巴瘤、系统性间变性大细胞淋巴瘤及CD30阳性皮肤T细胞淋巴瘤患者中的有效性与安全性。方法：这项多中心、非干预性、回顾性病历研究分析了西班牙43例接受本妥昔单抗再治疗患者的医疗记录。纳入标准为既往接受过本妥昔单抗治疗的复发或难治性经典型霍奇金淋巴瘤、系统性间变性大细胞淋巴瘤或CD30阳性皮肤T细胞淋巴瘤患者。研究分析了人口学特征、疾病分期、治疗反应、生存结局及不良事件。结果：研究人群包括16例经典型霍奇金淋巴瘤患者、13例系统性间变性大细胞淋巴瘤患者及14例皮肤T细胞淋巴瘤患者。患者以男性为主（58.1%），平均年龄46.2岁，基线ECOG评分0-1分。根据Ann Arbor分期系统，经典型霍奇金淋巴瘤和系统性间变性大细胞淋巴瘤患者疾病分期为I至IVB期；而根据EORTC临床分期标准，皮肤T细胞淋巴瘤患者分期为IA至IVB期。本妥昔单抗再治疗的总体缓解率达76.7%，其中系统性间变性大细胞淋巴瘤患者缓解率最高（92.3%）。60.5%的患者达到完全缓解。中位无进展生存期为25.4个月，总生存期达50个月。治疗失败发生率为37.2%。本妥昔单抗总体耐受性良好，周围神经病变是最常见的不良事件。结论：BELIEVE研究是迄今规模最大的证实本妥昔单抗再治疗可作为复发或难治性CD30阳性恶性肿瘤患者有效且耐受性良好治疗选择的研究。
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