Kim Seok Jin, Do Young Rok, Lee Ho-Sup, Lee Won-Sik, Kong Jee Hyun, Kwak Jae-Yong, Eom Hyeon-Seok, Moon Joon Ho, Yi Jun Ho, Lee Jeong-Ok, Jo Jae-Cheol, Yang Deok-Hwan
Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Department of Internal Medicine, Dongsan Medical Center, Daegu, Korea.
Blood Res. 2023 Dec 31;58(4):194-200. doi: 10.5045/br.2023.2023206. Epub 2023 Nov 30.
Brentuximab vedotin (BV), a potent antibody-drug conjugate, targets the CD30 antigen. In Korea, BV has been approved for the treatment of relapsed or refractory Hodgkin lymphoma (HL), anaplastic large-cell lymphoma (ALCL), and cutaneous T-cell lymphomas, including mycosis fungoides (MF). However, there are limited data reflecting real-world experiences with BV treatment for HL, ALCL, and MF.
This was a multicenter, non-interventional registry study of the efficacy and safety of BV in patients with relapsed or refractory CD30-positive lymphoma (CISL1803/BRAVO). Outcomes were determined based on the occurrence of relapse or progression and overall survival after BV treatment.
A total of 85 patients were enrolled in this study. The median number of BV cycles was 10 (range, 2‒16) in the patients with HL. The objective response rate (ORR) of patients with HL to BV was 85.4% (41/48), comprising 27 complete responses (CRs) and 14 partial responses (PRs). The ORR of ALCL was 88% (22/25), consisting of 17 CRs and five PRs, whereas the ORR of MF was 92% (11/12). At the median follow-up of 44.6 months after BV treatment, the median post-BV progression-free survival of HL, ALCL, and MF patients was 23.6 months, 29.0 months, and 16.7 months, respectively (=0.641). The most common side effect of BV was peripheral neuropathy; 22 patients (25.9%, 22/85) experienced peripheral neuropathy (all grades).
The treatment outcomes of patients with relapsed or refractory CD30-positive lymphoma improved with BV treatment, and the safety profile was manageable.
本妥昔单抗(BV)是一种强效抗体药物偶联物,靶向CD30抗原。在韩国,BV已被批准用于治疗复发或难治性霍奇金淋巴瘤(HL)、间变性大细胞淋巴瘤(ALCL)以及皮肤T细胞淋巴瘤,包括蕈样肉芽肿(MF)。然而,反映BV治疗HL、ALCL和MF真实世界经验的数据有限。
这是一项关于BV治疗复发或难治性CD30阳性淋巴瘤(CISL1803/BRAVO)疗效和安全性的多中心、非干预性注册研究。结局根据BV治疗后复发或进展的发生情况以及总生存期来确定。
本研究共纳入85例患者。HL患者BV治疗的中位周期数为10(范围2 - 16)。HL患者对BV的客观缓解率(ORR)为85.4%(41/48),包括27例完全缓解(CR)和14例部分缓解(PR)。ALCL的ORR为88%(22/25),包括17例CR和5例PR,而MF的ORR为92%(11/12)。在BV治疗后的中位随访44.6个月时,HL、ALCL和MF患者BV治疗后的中位无进展生存期分别为23.6个月、29.0个月和16.7个月(=0.641)。BV最常见的副作用是周围神经病变;22例患者(25.9%,22/85)出现周围神经病变(所有级别)。
BV治疗使复发或难治性CD30阳性淋巴瘤患者的治疗结局得到改善,且安全性可控。