Gut microbiome characteristics in patients with hormone receptor–positive (HR+) HER2− breast cancer treated with adjuvant abemaciclib: Biomarker analysis of the TRADE trial
Abstract
563
Background:
Adjuvant abemaciclib reduces recurrence risk and improves overall survival in patients with high-risk node-positive early HR+/HER2- breast cancer. However, treatment-emergent diarrhea may lead to dose modifications, treatment discontinuation, and impaired quality of life. The gut microbiome influences treatment response and toxicity across multiple cancer therapies; its role in abemaciclib-associated diarrhea remains undefined. We evaluated features of the gut microbiome during the initiation of adjuvant abemaciclib and any association with diarrhea.
Methods:
90 patients with HR+/HER2− early breast cancer enrolled in the TRADE trial (NCT06001762) and were treated with dose-escalated adjuvant abemaciclib (50 mg BID x 14 days, then 100 mg BID x 14 days, then 150 mg BID onwards) plus endocrine therapy. Stool samples were collected at baseline, cycle 2 day 1 (C2D1), and end of treatment (EOT). Whole-genome shotgun metagenomic sequencing was performed, and species-level profiles were generated using MetaPhlAn4. Diarrhea was analyzed as a binary outcome (ever vs none). Associations between microbiome features and clinical variables were evaluated using linear mixed modeling with a random effect for repeated samples from the same individual (alpha diversity) or per-timepoint using PERMANOVA (beta diversity) and MaAsLin3 (species and genes, with false discovery rate correction). Models were adjusted for age, cancer stage, and type of endocrine therapy.
Results:
A…
Read the paper
Related studies
- Bile Acid 7α-Dehydroxylating Gut Bacteria Secrete Antibiotics that Inhibit Clostridium difficile: Role of Secondary Bile Acids
- Ketogenic diet alleviates colitis by reduction of colonic group 3 innate lymphoid cells through altering gut microbiome
- Altered gut microbiome composition and function are associated with gut barrier dysfunction in healthy relatives of patients with Crohn's disease
- Diet, obesity, and the gut microbiome as determinants modulating metabolic outcomes in a non-human primate model
- Immune Impairment Associated with Vitamin A Deficiency: Insights from Clinical Studies and Animal Model Research
- Glyphosate-based herbicides influence antioxidants, reproductive hormones and gut microbiome but not reproduction: A long-term experiment in an avian model
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.