Management and Outcomes of Clostridioides difficile Infection in Patients on Immune Checkpoint Inhibitors
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Clinical Microbiology Service, Department of Laboratory Medicine, Memorial Sloan Kettering Cancer Center, New York, NY
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Clinical Microbiology Service, Department of Laboratory Medicine, Memorial Sloan Kettering Cancer Center, New York, NY
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Melanoma Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY
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Gastroenterology, Hepatology, and Nutrition Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY
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Gastroenterology, Hepatology, and Nutrition Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY
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Background: Data on the severity, management, and outcomes of Clostridioides difficile infection (CDI) in patients presenting with diarrhea while receiving immune checkpoint inhibitors (ICIs) are limited. This study aimed to evaluate the course of CDI in this population and the overlapping diagnosis of immune-related enterocolitis (irEC). Methods: This retrospective cohort included ICI-treated patients who presented with diarrhea and underwent CDI stool nucleic acid amplification PCR testing at Memorial Sloan Kettering Cancer Center between July 2015 and July 2021. Primary outcomes included CDI frequency, treatment regimens, and the need for immunosuppression for irEC. Results: Among 605 ICI-treated patients presenting with diarrhea, 111 (18%) tested positive for CDI. Of these, 84 (76%) were successfully treated with antibiotics alone, whereas 27 (24%) received additional immunosuppressive therapy for suspected or confirmed irEC. Compared with CDI-negative patients, those with CDI had higher rates of prior antibiotic exposure, abdominal pain, fever, bloody stools, and more severe diarrhea and colitis. However, they had lower rates of irEC requiring immunosuppression. Factors associated with the receipt of immunosuppression included CTLA-4–based immunotherapy and grade 3–4 diarrhea and colitis. The CDI recurrence rate was 20%, regardless of the treatment regimen used. Conclusions: In the largest cohort to date of ICI-treated patients with diarrhea, CDI was identified in 18% of cases and was associated with prior antibiotic therapy. Most patients responded to antibiotics alone; however, 24% required immunosuppression for concurrent irEC, and 20% experienced CDI recurrence. Prompt CDI testing and thoughtful clinical treatment and monitoring may improve outcomes in this population.
Submitted June 19, 2024; final revision received December 20, 2024; accepted for publication December 20, 2024.
Author contributions: Conception & design: Magahis, Satish, Laszkowska, Faleck. Provision of study material or patients: Faleck. Collection and/or assembly of data: Magahis, Satish, Laszkowska, Faleck. Data analysis & interpretation: Magahis, Kamboj, Kalvin, Panageas, Postow, Faleck. Writing—original draft: Magahis, Faleck. Writing—review & editing: All authors.
Data availability statement: Deidentified data will be made available by the corresponding author upon reasonable request.
Disclosures: Dr. Postow has disclosed serving as a consultant for Bristol Myers Squibb, Merck, Novartis, Eisai, Pfizer, Erasca, Nektar, Lyvgen, and Chugai; and receiving institutional grant/research support from Rgenix, Infinity Pharmaceuticals, Bristol Myers Squibb, Merck, Genentech, BioAtla, and Novartis. Dr. Laszkowska has disclosed receiving grant/research support from AI Medical Service Inc. Dr. Faleck has disclosed serving as a consultant for Ferring Pharmaceuticals, Gilead Sciences, Janssen, OnQuality Pharmaceuticals, and Teva. The remaining authors have disclosed that they have not received any financial consideration from any person or organization to support the preparation, analysis, results, or discussion of this article.
Funding: This work was supported by funding through the NIH/NCI Cancer Center Support Grant P30 CA008748.
Supplementary material: Supplementary material associated with this article is available online at https://doi.org/10.6004/jnccn.2024.7355. The supplementary material has been supplied by the author(s) and appears in its originally submitted form. It has not been edited or vetted by JNCCN. All contents and opinions are solely those of the author. Any comments or questions related to the supplementary materials should be directed to the corresponding author.
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