Systematic Review and Meta-analysis Expert Group (SRMEG), Universal Scientific Education and Research Network (USERN), Tehran, Iran.
Cancer Immunology Project (CIP), Universal Scientific Education and Research Network (USERN), Tehran, Iran.
Expert Rev Anticancer Ther. 2023 Mar;23(3):307-318. doi: 10.1080/14737140.2023.2183847. Epub 2023 Mar 1.
Immunotherapy is a promising and progressing treatment approach for cancer. Bispecific antibodies (BsAbs) are antibody constructs that can bind to two different epitopes. The dual-specificity of BsAbs improves their efficacy compared to monoclonal antibodies.
Although BsAbs have achieved excellent therapeutic effects in hematologic cancers, no systematic review with meta-analysis evaluated their efficacy in solid tumors. In the present systematic review and meta-analysis, we aimed to establish the clinical efficacy and safety of BsAbs in solid tumors.
BsAbs are not associated with significantly better safety or efficacy outcomes than conventional therapies. BsAb was not associated with improvement in overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and disease control rate (DCR). However, BsAb increased the rate of stable disease (SD) significantly. Also, BsAb substantially increased the OS and PFS and resulted in a higher frequency of DCR for uveal melanoma. Furthermore, the safety analysis showed no obvious difference in the rate of any adverse events (AEs), grade ≥3 AEs, serious AEs, and AEs leading to treatment discontinuation in the intervention group compared to controls. Further high-quality randomized controlled trials on BsAbs in solid tumors are highly recommended.
免疫疗法是一种有前途且不断发展的癌症治疗方法。双特异性抗体（BsAbs）是一种可以结合两个不同表位的抗体构建体。BsAbs 的双重特异性提高了其与单克隆抗体相比的疗效。
尽管 BsAbs 在血液系统癌症中已取得优异的治疗效果，但尚无系统评价和荟萃分析评估其在实体瘤中的疗效。在本系统评价和荟萃分析中，我们旨在确定 BsAbs 在实体瘤中的临床疗效和安全性。
BsAbs 与常规疗法相比，在安全性或疗效方面没有显著改善。BsAb 与总生存期（OS）、无进展生存期（PFS）、客观缓解率（ORR）和疾病控制率（DCR）的改善无关。然而，BsAb 显著增加了疾病稳定率（SD）。此外，BsAb 显著延长了葡萄膜黑色素瘤患者的 OS 和 PFS，并且导致更高的 DCR 频率。此外，安全性分析显示，干预组与对照组之间任何不良事件（AE）、≥3 级 AE、严重 AE 和导致治疗中断的 AE 的发生率无明显差异。强烈推荐进一步开展高质量的 BsAbs 在实体瘤中的随机对照试验。
