Cited by 161Cancer Immunotherapy and BiomarkersGut microbiota and healthInflammatory Bowel Disease

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Microbiome alteration via fecal microbiota transplantation is effective for refractory immune checkpoint inhibitor–induced colitis

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Halsey, Taylor M., Thomas, Anusha S., Hayase, Tomo, Ma, Weijie, Abu-Sbeih, Hamzah, Sun, Baohua, Parra, Edwin Roger, Jiang, Zhi-Dong, DuPont, Herbert L., Sanchez, Christopher, El-Himri, Rawan, Brown, Alexandria, Flores, Ivonne, McDaniel, Lauren, Ortega Turrubiates, Miriam, Hensel, Matthew, Pham, Dung, Watowich, Stephanie S., Hayase, Eiko, Chang, Chia-Chi, Jenq, Robert R., Wang, Yinghong·2023·Science Translational Medicine

DOI 10.1126/scitranslmed.abq4006PMC PMC10759507

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Abstract

Immune checkpoint inhibitors (ICIs) target advanced malignancies with high efficacy but also predispose patients to immune-related adverse events like immune-mediated colitis (IMC). Given the association between gut bacteria with response to ICI therapy and subsequent IMC, fecal microbiota transplantation (FMT) represents a feasible way to manipulate microbial composition in patients, with a potential benefit for IMC. Here, we present a large case series of 12 patients with refractory IMC who underwent FMT from healthy donors as salvage therapy. All 12 patients had grade 3 or 4 ICI-related diarrhea or colitis that failed to respond to standard first-line (corticosteroids) and second-line immunosuppression (infliximab or vedolizumab). Ten patients (83%) achieved symptom improvement after FMT, and three patients (25%) required repeat FMT, two of whom had no subsequent response. At the end of the study, 92% achieved IMC clinical remission. 16 S rRNA sequencing of patient stool samples revealed that compositional differences between FMT donors and patients with IMC before FMT were associated with a complete response after FMT. Comparison of pre- and post-FMT stool samples in patients with complete responses showed significant increases in alpha diversity and increases in the abundances of Collinsella and Bifidobacterium , which were depleted in FMT responders before FMT. Histologically evaluable complete response patients also had decreases in select immune cells , including CD8 + T cells, in the colon after FMT when compared with non-complete response patients ( n = 4). This study validates FMT as an effective treatment strategy for IMC and gives insights into the microbial signatures that may play a critical role in FMT response.

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Authors: Halsey, T. M., Thomas, A. S., Hayase, T., Ma, W., Abu-Sbeih, H., Sun, B., Parra, E. R., Jiang, Z.-D., DuPont, H. L., Sanchez, C., El-Himri, R., Brown, A., Flores, I., McDaniel, L., Ortega Turrubiates, M., Hensel, M., Pham, D., Watowich, S. S., Hayase, E., Chang, C.-C., Jenq, R. R., & Wang, Y.
Affiliations: The University of Texas MD Anderson Cancer Center (US)
Department of Gastroenterology, Hepatology and Nutrition, University of Texas MD Anderson Cancer Center, Houston, TX 77054, USA.
Center for Infectious Diseases, School of Public Health, University of Texas, Houston, TX 77054, USA.
Kelsey Research Foundation (US)
Department of Genomic Medicine, University of Texas MD Anderson Cancer Center, Houston, TX 77054, USA.
Middlebury College (US)
Corresponding author: Halsey, Taylor M.
Thomas, Anusha S.
Jenq, Robert R.
Wang, Yinghong
ORCID: Halsey, Taylor M.
Thomas, Anusha S.
Hayase, Tomo
Ma, Weijie
Sun, Baohua
Parra, Edwin Roger
Jiang, Zhi-Dong
DuPont, Herbert L.
Brown, Alexandria
Flores, Ivonne
McDaniel, Lauren
Pham, Dung
Watowich, Stephanie S.
Hayase, Eiko
Chang, Chia-Chi
Jenq, Robert R.
Wang, Yinghong
Venue: Science Translational Medicine
Publisher: American Association for the Advancement of Science (AAAS)
Published: 2023-06-14
Volume: 15
Issue: 700
Pages: eabq4006-eabq4006
ISSN: 1946-6234 (ISSN-L)
1946-6242
DOI: 10.1126/scitranslmed.abq4006
PMC: PMC10759507
OpenAlex: W4380590697
Cited by: 161
References: 66
Citations by year: 2026: 54 · 2025: 55 · 2024: 47 · 2023: 5
FWCI: 19.55
Type: journal article
Language: en
Open access: hybrid
doi.org
Licence: cc-by
Locations: Science Translational Medicine (publishedVersion, cc-by)
PubMed (publishedVersion)
PubMed Central (acceptedVersion)
Digital Commons-TMC (Texas Medical Center) (submittedVersion)
Funders: Cancer Prevention and Research Institute of Texas (RP210042)
Seres Therapeutics
University of Texas MD Anderson Cancer Center
National Heart, Lung, and Blood Institute (R01HL124112)
National Cancer Institute (P30CA016672)
Moonshot Research and Development Program
Topics: Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Gut microbiota and health
Health Sciences › Medicine › Gastroenterology › Inflammatory Bowel Disease
Keywords: fecal microbiota transplantation, immune checkpoint inhibitors, immune-related colitis, immune-related adverse events, refractory colitis, gut microbiota, microbial signatures, Collinsella, Bifidobacterium, alpha diversity, CD8+ T cells, immunosuppressive therapy
MeSH terms: Fecal Microbiota Transplantation, Immune Checkpoint Inhibitors, Aged, Colitis, Feces, Female, Humans, Male, Middle Aged, RNA, Ribosomal, 16S

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Microbiome alteration via fecal microbiota transplantation is effective for refractory immune checkpoint inhibitor–induced colitis

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