Yang Yue, Liu Shu-Rong, Wang Li, Zhang Rui, Xie Jing
Department of Trauma and Hand and Foot Microsurgery, Sunshine Union Hospital, Weifang, China.
Department of Oncology, Sunshine Union Hospital, Weifang, China.
Front Oncol. 2025 Jul 21;15:1636923. doi: 10.3389/fonc.2025.1636923. eCollection 2025.
Brentuximab vedotin (BV), an anti-CD30 antibody-drug conjugate, has established efficacy in relapsed/refractory Hodgkin lymphoma (HL), yet its role as frontline therapy for newly diagnosed classical HL requires systematic evaluation.
We conducted a meta-analysis of randomized controlled trials (RCTs) compared BV-based versus conventional non-BV-containing regimens (namely, classical chemotherapeutic regimens) in previously untreated classical HL patients, assessing progression-free survival (PFS), PET metabolic responses (interim PET-2 negativity and end-of-treatment complete response), and safety profiles (grade ≥3 adverse events [AEs], including febrile neutropenia, peripheral neuropathy, and secondary malignancies).
Pooled data from four RCTs (N = 3591 patients) demonstrated significant PFS improvement with BV-based regimens (HR: 0.58, 95% CI: 0.44 to 0.77, < 0.001), with consistent benefits across subgroups stratified by disease stage, gender, age, and International Prognostic Score (IPS). Although interim PET-2 negativity rates showed only a non-significant trend favoring BV (RR: 1.02, 95% CI: 0.99 to 1.04, = 0.286), end-of-treatment complete metabolic response rates were significantly higher (RR: 1.03, 95% CI: 1.00 to 1.06, = 0.024). Safety analyses revealed comparable incidences of grade ≥3 AEs between groups (RR: 1.05, 95% CI: 0.80 to 1.37, = 0.739), with no increased risk of peripheral neuropathy or secondary malignancies.
Our meta-analysis demonstrates that incorporation of BV into frontline therapy for classical HL provides significant PFS benefits and improved end-of-treatment metabolic responses, with manageable toxicity. These findings support BV-based regimens as a promising frontline therapeutic strategy in classical HL, though extended follow-up is required to evaluate long-term survival outcomes.
本妥昔单抗（BV）是一种抗CD30抗体药物偶联物，在复发/难治性霍奇金淋巴瘤（HL）中已确立疗效，但其作为新诊断经典型HL一线治疗的作用需要系统评估。
我们对随机对照试验（RCT）进行了荟萃分析，比较基于BV的方案与传统不含BV的方案（即经典化疗方案）在既往未治疗的经典型HL患者中的疗效，评估无进展生存期（PFS）、PET代谢反应（中期PET-2阴性和治疗结束时完全缓解）以及安全性（≥3级不良事件[AEs]，包括发热性中性粒细胞减少、周围神经病变和继发性恶性肿瘤）。
来自四项RCT（N = 3591例患者）的汇总数据显示，基于BV的方案可显著改善PFS（HR：0.58，95%CI：0.44至0.77，P<0.001），在按疾病分期、性别、年龄和国际预后评分（IPS）分层的亚组中均有一致的获益。尽管中期PET-2阴性率仅显示出有利于BV的非显著趋势（RR：1.02，95%CI：0.99至1.04，P = 0.286），但治疗结束时完全代谢缓解率显著更高（RR：1.03，95%CI：1.00至1.06，P = 0.024）。安全性分析显示两组间≥3级AEs的发生率相当（RR：1.05，95%CI：0.80至1.37，P = 0.739），周围神经病变或继发性恶性肿瘤风险未增加。
我们的荟萃分析表明，将BV纳入经典型HL的一线治疗可显著改善PFS，并改善治疗结束时的代谢反应，且毒性可控。这些发现支持基于BV的方案作为经典型HL有前景的一线治疗策略，不过需要延长随访以评估长期生存结果。
