Zhao Zhiqiang, Yu Qinchuan, Su Liping, He Jianxia, Tao Jie, Xi Yanfeng, Guo Yujiao, Luo Yanhong, Wang Lieyang
Department of Hematology, Shanxi Province Cancer Hospital/ Shanxi Hospital Affiliated to Cancer Hospital, Chinese Academy of Medical Sciences/Cancer Hospital Affiliated to Shanxi Medical University, Taiyuan, Shanxi, China.
Department of Hematology, Shanxi Provincial People's Hospital, Taiyuan, Shanxi, China.
Front Oncol. 2025 Jan 7;14:1494384. doi: 10.3389/fonc.2024.1494384. eCollection 2024.
Brentuximab vedotin (BV) has demonstrated high remission rates in clinical trials for systemic anaplastic large cell lymphoma (sALCL), yet its real-world effectiveness in China remains unconfirmed. This retrospective observational study evaluates BV-based regimens in patients with sALCL, treated from 2020 to 2023.
A multi-center observational retrospective study was conducted on patients with sALCL received BV plus cyclophosphamide, doxorubicin, and prednisone (CHP) upfront or BV plus gemcitabine, oxaliplatin(GemOx), gemcitabine, cisplatin, dexamethasone(GDP), or isocyclophosphamide, carboplatin, etoposide (ICE)for later lines. Primary endpoints were complete response rate (CRR) and overall response rate (ORR); secondary endpoints included progression-free survival (PFS), overall survival (OS), duration of response (DOR), and the incidence of adverse events (AEs).
Among the 38 patients (28 newly diagnosed and 10 with refractory/relapsed disease), the ORR were 100% (with 89.3% CR) for newly diagnosed patients and 70% (with 50% CR) for refractory/relapsed patients. The median duration of response was 14 months for newly diagnosed patients and 23.8 months for those with refractory/relapsed disease. 2-year Survival rates were 100% for newly diagnosed patients and 80% for refractory/relapsed patients, with 2-year PFS rates of 92.8% and 70%, respectively. Neurological toxicities were commonly observed but resolved following the completion of treatment.
BV has proven to be effective and well-tolerated in real-world settings for the treatment of sALCL, reinforcing its potential as a promising option for first-line or subsequent therapy. The sustained efficacy observed post-CR suggests that these patients may have a prolonged disease control.
在系统性间变性大细胞淋巴瘤（sALCL）的临床试验中，维布妥昔单抗（BV）已显示出高缓解率，但其在中国的真实疗效仍未得到证实。本回顾性观察性研究评估了2020年至2023年期间接受治疗的sALCL患者中基于BV的治疗方案。
对接受BV联合环磷酰胺、阿霉素和泼尼松（CHP）一线治疗或BV联合吉西他滨、奥沙利铂（GemOx）、吉西他滨、顺铂、地塞米松（GDP）或异环磷酰胺、卡铂、依托泊苷（ICE）二线及后续治疗的sALCL患者进行了一项多中心观察性回顾性研究。主要终点为完全缓解率（CRR）和总缓解率（ORR）；次要终点包括无进展生存期（PFS）、总生存期（OS）、缓解持续时间（DOR）和不良事件（AE）的发生率。
在38例患者（28例新诊断患者和10例难治性/复发性疾病患者）中，新诊断患者的ORR为100%（CR为89.3%），难治性/复发性患者的ORR为70%（CR为50%）。新诊断患者的中位缓解持续时间为14个月，难治性/复发性疾病患者为23.8个月。新诊断患者的两年生存率为100%，难治性/复发性患者为80%，两年PFS率分别为92.8%和70%。神经毒性常见，但在治疗结束后得到缓解。
在真实世界中，BV已被证明对治疗sALCL有效且耐受性良好，这进一步证明了其作为一线或后续治疗的有前景选择的潜力。CR后观察到的持续疗效表明这些患者可能有更长的疾病控制期。
