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. 2017 Jul;32(7):1077-1084.
doi: 10.1007/s00384-017-2819-3. Epub 2017 Apr 25.

Study protocol on the role of intestinal microbiota in colorectal cancer treatment: a pathway to personalized medicine 2.0

R Aarnoutse  1   2 , J M P G M de Vos-Geelen  3 , J Penders  4 , E G Boerma  5 , F A R M Warmerdam  6 , B Goorts  1   2 , S W M Olde Damink  2   7 , Z Soons  7 , S S M Rensen  7 , M L Smidt  8   9
Affiliations

Study protocol on the role of intestinal microbiota in colorectal cancer treatment: a pathway to personalized medicine 2.0

R Aarnoutse et al. Int J Colorectal Dis. 2017 Jul.

Abstract

Purpose: Investigate in patients with metastatic and/or irresectable colorectal cancer treated with systemic treatment with capecitabine or TAS-102 whether: 1. Intestinal microbiota composition can act as a predictor for response. 2. Intestinal microbiota composition changes during systemic treatment and its relation to chemotoxicity.

Background: Gut 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.

Methods: An 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.

Conclusions: 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. 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.

Keywords: Colorectal cancer treatment; Intestinal microbiota.

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Conflict of interest statement

The national Dutch Research Ethics Committee of Maastricht University Medical Centre+ approved the study protocol in December 2016.

Figures

Fig. 1
Fig. 1
Schematic overview of the study procedure for patients treated with capecitabine (with or without bevacizumab)
Fig. 2
Fig. 2
Schematic overview of the study procedure for patients treated with TAS-102
See this image and copyright information in PMC

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