Early Monitoring Helps Curb GI Toxicity From Immunotherapy

M. Alexander Otto, PA, MMS

November 11, 2022

The study covered in this summary was published on researchsquare.com as a preprint and has not yet been peer reviewed.

Key Takeaway

  • A quality improvement program at MD Anderson Cancer Center, Houston, Texas, substantially improved outcomes from severe immune-mediated diarrhea and colitis.

Why This Matters

  • Immune-mediated diarrhea and colitis is a common and vexing complication of immune checkpoint inhibitor therapy.

  • The current study shows that a standardized approach to evaluating and treating immune-mediated diarrhea and colitis led to faster recovery and fewer hospital readmissions.

Study Design

  • MD Anderson implemented a treatment algorithm for patients admitted with severe immune-mediated diarrhea and colitis and codified it as a standing order set in its electronic health records system.

  • The order set included GI consult and endoscopic evaluation on admission, early introduction of infliximab and/or vedolizumab when patients didn't respond to steroids, and close GI follow-up after discharge.

  • To evaluate the program, the team compared outcomes in 59 patients before it was implemented with outcomes in 67 patients after it was well established.

  • There were no significant differences in the baseline immune-mediated diarrhea and colitis severity between the two groups.  

Key Results

  • Patients in the post-treatment program experienced a shorter duration to clinical remission (4 vs 10 days) as well as higher rates of GI consultation (82% vs 53%), endoscopic evaluation (70% vs 49%), and post-discharge GI follow-up (50% vs 32%).

  • Those in the post-treatment program also experienced significantly fewer immune-mediated diarrhea and colitis recurrences (24% vs 49%) and fewer hospital readmissions (25% vs 51%).


  • Implementing the program may not be possible in a community setting.


  • There was no external funding reported for the study, and the investigators did not report any disclosures.

This is a summary of a preprint research study, “Implementing an Immunotherapy Toxicity (IOTOX) GI Service Improves Outcomes in Patients with Immune Mediated Diarrhea and Colitis,” led by Alice Saji of MD Anderson Cancer Center, Houston, Texas, provided to you by Medscape. The study has not been peer reviewed. The full text can be found at researchsquare.com.

M. Alexander Otto is a physician assistant with a master’s degree in medical science and a journalism degree from Newhouse. He is an award-winning medical journalist who has worked for several major news outlets before joining Medscape and also an MIT Knight Science Journalism fellow. Email: aotto@mdedge.com.

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