Abstract
PurposeInvestigate in patients with metastatic and/or irresectable colorectal cancer treated with systemic treatment with capecitabine or TAS-102 whether:Intestinal microbiota composition can act as a predictor for response.Intestinal microbiota composition changes during systemic treatment and its relation to chemotoxicity.BackgroundGut microbiota and host determinants evolve in symbiotic and dependent relationships resulting in a personal ecosystem. In vitro studies showed prolonged and increased response to 5-fluorouracil, a fluoropyrimidine, in the presence of a favorable microbiota composition. Capecitabine and TAS-102 are both fluoropyrimidines used for systemic treatment in colorectal cancer patients.MethodsAn explorative prospective multicenter cohort study in the Maastricht University Medical Centre+ and Zuyderland Medical Centre will be performed in 66 patients. Before, during, and after three cycles of systemic treatment with capecitabine or TAS-102, fecal samples and questionnaires (concerning compliance and chemotoxicity) will be collected. The response will be measured by CT/MRI using RECIST-criteria. Fecal microbiota composition will be analyzed with 16S rRNA next-generation sequencing. The absolute bacterial abundance will be assessed with quantitative polymerase chain reaction. Multivariate analysis will be used for statistical analysis.ConclusionsWe aim to detect a microbiota composition that predicts if patients with metastatic and/or irresectable colorectal cancer will respond to systemic treatment and/or experience zero to limited chemotoxicity. If we are able to identify a favorable microbiota composition, fecal microbiota transplantation might be the low-burden alternative to chemotherapy switch in the future.
Highlights
Gut microbiota and host determinants evolve in symbiotic and dependent relationships resulting in a personal ecosystem
We aim to detect a microbiota composition that predicts if patients with metastatic and/or irresectable colorectal cancer will respond to systemic treatment and/or experience zero to limited chemotoxicity
This study aims to bridge this translational gap in order to explore the importance of the human intestinal microbiota in Colorectal cancer (CRC) treatment by initiating an explorative prospective multicenter cohort study in the Maastricht University Medical Centre and Zuyderland Medical Centre
Summary
The primary object is to investigate whether the microbiota composition can act as a predictor for response and/or chemotoxicity to three cycles of systemic treatment with capecitabine (with or without bevacizumab) or TAS-102 in patients with metastatic and/or irresectable CRC. The secondary objective of this study is to investigate the microbiota composition changes during systemic treatment with capecitabine (with or without bevacizumab) or TAS-. 102 and its relation to response and/or chemotoxicity in patients with metastatic and/or irresectable CRC
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