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Microbiota boost immunotherapy? A meta-analysis dives into fecal microbiota transplantation and immune checkpoint inhibitors

Anqi Lin (Zhujiang Hospital, Kangda College of Nanjing Medical University), Lihaoyun Huang (Zhujiang Hospital, Southern Medical University), Aimin Jiang (Second Military Medical University, Changhai Hospital), Lingxuan Zhu (Zhujiang Hospital, Southern Medical University), Weiming Mou (Shanghai Jiao Tong University, Zhujiang Hospital), Haijun Yu (Zhujiang Hospital, Southern Medical University), Chunyan Zhang (Zhujiang Hospital, Southern Medical University), Zaoqu Liu (Chinese Academy of Medical Sciences & Peking Union Medical College, Institute of Basic Medical Sciences of the Chinese Academy of Medical Sciences), Jian Zhang (Zhujiang Hospital, Southern Medical University), Quan Cheng (Central South University, Xiangya Hospital Central South University), Ting Wei (Zhujiang Hospital, Southern Medical University), Peng Luo (Zhujiang Hospital, Kangda College of Nanjing Medical University)

BMC Medicine
License: CC BY-NC-ND

Abstract: BACKGROUND: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.

Published on 08 Jun. 2025