Washed microbiota transplantation alleviates tyrosine kinase inhibitors associated gastrointestinal adverse effects

Abstract Gut microbiota dysbiosis is implicated in tyrosine kinase inhibitor (TKI)‐induced gastrointestinal adverse effects (GAEs), often necessitating medication adjustments or discontinuation in severe or persistent cases. This study aimed to evaluate the efficacy and safety of washed microbiota transplantation (WMT) in managing TKI‐induced GAEs. This prospective study involved cancer patients presenting TKI‐induced GAEs. The primary outcome was the clinical remission rate at Week 8 post‐WMT, which was assessed by the common terminology criteria for adverse events grade. The secondary outcomes included the clinical asymptomatic rate, the onset time of clinical remission, and the variation of C‐reactive protein (CRP) levels. Twenty‐four patients undergoing 66 WMTs were analyzed. The overall clinical remission and asymptomatic rates were 75.00% (18/24) and 29.17% (7/24), respectively. GAEs, including diarrhea, abdominal pain, and abdominal distention, showed significant improvement post‐WMT (all p < .05), while hematochezia exhibited a decreasing trend in severity. Median time to remission was 14.5 days (inter‐quartile range, 7–24). Within 8 weeks post‐WMT, three initially responsive patients experienced relapse. CRP levels significantly decreased ( p < .05), and no severe adverse events were reported. This study proposes WMT as a potential treatment for TKI‐induced GAEs, particularly for patients who do not respond adequately to conventional treatments.