Yan Yici, Yuan Jing, Peng Yanyang, Zhou Chenxi, Liu Xinbo, Sun Leitao, Song Qiaoling
The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine), Hangzhou, China.
School of Humanities and Management, Zhejiang Chinese Medical University, Hangzhou, China.
Front Immunol. 2025 Apr 25;16:1568724. doi: 10.3389/fimmu.2025.1568724. eCollection 2025.
Bispecific antibodies (bsAbs) introduced a novel strategy in anticancer therapy when chemotherapy alone could not meet life expectancy. Nonetheless, the efficacy of monotherapy was limited, and the safety profile of bsAbs combined with chemotherapy remained uncertain.
Literature retrieval was carried out through PubMed, Embase, and Cochrane from inception to January, 2025. Progression-free survival (PFS), overall survival (OS), and overall response rate (ORR), along with adverse effects (AEs), were utilized to assess the efficacy and safety. Publication bias was calculated using Funnel plots and Egger's test. Heterogeneity was examined through subgroup and sensitivity analyses. The protocol was preregistered in the International Prospective Register of Systematic Reviews (CRD42025633628).
A total of 8 eligible clinical studies with 2,495 patients were included. Compared with chemotherapy alone, bsAb+chemotherapy exhibited positive outcomes in PFS (hazard ratio (HR): 0.52; 95% confidence interval (CI): 0.44-0.60; p<0.01), OS (HR: 0.67, 95% CI: 0.57-0.77; p<0.01), and ORR (HR: 0.31, 95% CI: 0.16-0.47; p<0.01). Subgroup analysis revealed that female patients, Asian patients, those under 65 years of age, and patients treated with IgG-like bsAb were more likely to benefit from the survival advantages of bsAb+chemotherapy. Despite the occurrence of leukopenia, metabolism-related, and skin-related AEs, RR of AEs in other systems showed no statistical significance.
BsAb+chemotherapy was superior to chemotherapy alone, especially in female patients, Asian patients, those under 65 years of age, and patients receiving IgG-like bsAb. Additionally, while the AEs associated with bsAb+chemotherapy are generally manageable, there is still room for improvement.
https://www.crd.york.ac.uk/prospero/, identifier CRD42025633628.
当单纯化疗无法满足预期寿命时，双特异性抗体（bsAbs）在抗癌治疗中引入了一种新策略。然而，单药治疗的疗效有限，bsAbs联合化疗的安全性仍不确定。
通过PubMed、Embase和Cochrane从创刊至2025年1月进行文献检索。无进展生存期（PFS）、总生存期（OS）、总缓解率（ORR）以及不良反应（AEs）被用于评估疗效和安全性。使用漏斗图和Egger检验计算发表偏倚。通过亚组分析和敏感性分析检查异质性。该方案已在国际前瞻性系统评价注册库（CRD42025633628）中预先注册。
共纳入8项符合条件的临床研究，涉及2495例患者。与单纯化疗相比，bsAb+化疗在PFS（风险比（HR）：0.52；95%置信区间（CI）：0.44-0.60；p<0.01））、OS（HR：0.67，95%CI：0.57-0.77；p<0.01）和ORR（HR：0.31，95%CI：0.16-0.47；p<0.01）方面显示出积极结果。亚组分析显示，女性患者、亚洲患者、65岁以下患者以及接受IgG样bsAb治疗的患者更有可能从bsAb+化疗的生存优势中获益。尽管出现了白细胞减少、代谢相关和皮肤相关的AE，但其他系统中AE的RR无统计学意义。
BsAb+化疗优于单纯化疗，尤其是在女性患者、亚洲患者、65岁以下患者以及接受IgG样bsAb治疗的患者中。此外，虽然与bsAb+化疗相关的AE通常是可控的，但仍有改进空间。
