Clinical analysis of fecal microbiota transplantation for refractory acute gastrointestinal graft-versus-host disease after allogeneic hematopoietic stem cell transplantation: a five-year retrospective study.
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BACKGROUND AIMS: Refractory acute gastrointestinal graft-versus-host disease (GI-aGVHD) is a severe complication following allogeneic hematopoietic stem cell transplantation (allo-HSCT), which is associated with significantly increased mortality. Fecal microbiota transplantation (FMT) has emerged as a promising therapeutic strategy for this condition, and its efficacy and safety have garnered substantial attention in clinical research. OBJECTIVE: To explore the clinical efficacy and safety of FMT for refractory acute GI-aGVHD after allo-HSCT. METHODS: Data from 22 patients with refractory GI-aGVHD who received FMT and 20 patients who did not undergo FMT, all diagnosed with refractory GI-aGVHD after allo-HSCT and treated at Henan Cancer Hospital between December 2017 and March 2023, were retrospectively analyzed to evaluate short-term efficacy, safety, and long-term survival outcomes. RESULTS: FMT significantly reduced the median diarrhea volume (1300 versus 450 mL, P = 0.017) and frequency (10 versus 5.5 times/d, P = 0.049) in the FMT group, whereas the control group showed no significant improvement in either parameter (diarrhea volume: 1350 versus 900 mL, P > 0.05; frequency: 10 versus 9 times/d, P > 0.05). The FMT group exhibited significantly higher complete response (CR) (31.8% versus 5%, P = 0.047) and overall response rate (ORR) (59.1% versus 25%, P = 0.033) compared with the control group. Subgroup analyses showed that patients with isolated intestinal involvement (ORR = 100%) and those without bloody stool before FMT (ORR = 78.6%) had superior responses to FMT. The FMT group achieved a median progression-free survival (PFS) of 30 (10-2113) days and a median overall survival (OS) of 150 (51-2130) days, with the 100-day, 1-year and 3-year PFS rates of 40.9%, 28.1%, and 28.1%, respectively, and the 100-day, 1-year and 3-year OS rates of 59.1%, 50.0% and 34.3%. In contrast, the control group had notably poorer survival outcomes: median PFS was 23 (7-1820) days, median OS was 80 (20-1901) days, while the 100-day, 1-year, and 3-year PFS rates remained 5% across all time points, and the 100-day, 1-year, and 3-year OS rates were 20.0%, 10.0%, and 10%. CONCLUSION: FMT is effective and safe as a clinical treatment for refractory GI-aGVHD after allo-HSCT, and the effectiveness of FMT can be used as a prognostic indicator for long-term survival in refractory GI-aGVHD.