Lin Anqi, Huang Lihaoyun, Jiang Aimin, Zhu Lingxuan, Mou Weiming, Li Yu, Zhang Chunyan, Liu Zaoqu, Zhang Jian, Cheng Quan, Wei Ting, Luo Peng
Donghai County People's Hospital (Affiliated Kangda College of Nanjing Medical University); Department of Oncology, Zhujiang Hospital, Southern Medical University, Lianyungang, China.
Department of Oncology, Zhujiang Hospital, Southern Medical University, Guangzhou, China.
BMC Med. 2025 Jun 9;23(1):341. doi: 10.1186/s12916-025-04183-y.
Immune checkpoint inhibitors (ICIs) are a cornerstone of modern cancer treatment, but their effectiveness is limited. Fecal microbiota transplantation (FMT), which alters the gut microbiome, has shown promise in enhancing ICIs' therapeutic effects.
We conducted a comprehensive search of relevant studies available up to September 30, 2024, to analyze the clinical efficacy and safety of combining FMT with ICIs in cancer treatment. The primary endpoint was the objective response rate (ORR), with secondary evaluations of survival outcomes and safety.
A total of 10 studies involving 164 patients with solid tumors were included. The pooled ORR was 43% (95% CI: 0.35-0.51). Subgroup analysis revealed that the combination of anti-PD-1 and anti-CTLA-4 therapies was associated with a significantly higher ORR (60%) compared to anti-PD-1 monotherapy (37%; P = 0.01). The incidence of grade 1-2 adverse events (AEs) was 42% (95% CI: 0.32-0.52), while grade 3-4 AEs occurred in 37% of patients (95% CI: 0.28-0.46).
This meta-analysis provides preliminary evidence supporting the use of FMT as a strategy to enhance the efficacy of ICIs in patients with advanced or refractory solid tumors. However, larger-scale randomized controlled trials with long-term follow-up are required to confirm and optimize treatment protocols.
免疫检查点抑制剂(ICIs)是现代癌症治疗的基石,但其有效性有限。粪便微生物群移植(FMT)可改变肠道微生物群,已显示出增强ICIs治疗效果的潜力。
我们全面检索了截至2024年9月30日的相关研究,以分析FMT联合ICIs在癌症治疗中的临床疗效和安全性。主要终点是客观缓解率(ORR),次要评估生存结局和安全性。
共纳入10项研究,涉及164例实体瘤患者。汇总的ORR为43%(95%CI:0.35-0.51)。亚组分析显示,与抗PD-1单药治疗(37%;P = 0.01)相比,抗PD-1和抗CTLA-4联合治疗的ORR显著更高(60%)。1-2级不良事件(AEs)的发生率为42%(95%CI:0.32-0.52),而3-4级AEs发生在37%的患者中(95%CI:0.28-0.46)。
这项荟萃分析提供了初步证据,支持使用FMT作为增强晚期或难治性实体瘤患者ICIs疗效的策略。然而,需要更大规模的长期随访随机对照试验来证实并优化治疗方案。