Real-World Management and Outcomes of Immune-Mediated Diarrhea and Colitis: Gaps in Guideline Adherence and Opportunities for Implementation

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Delays in IMDC reporting and inconsistent guideline adherence increase symptom burden and emergency department (ED) utilization. Although current practice guidelines provide IMDC management recommendations, adherence in routine oncology care remains uncertain. This study evaluated IMDC management and guideline concordance at a single National Cancer Institute–designated comprehensive cancer center to identify workflow opportunities to improve supportive management. Methods We conducted a retrospective observational study of adults treated with ICIs between 2011 and 2024 who developed IMDC. Electronic health record (EHR) data were used to characterize patient demographics, IMDC reporting patterns, and to assess National Comprehensive Cancer Network (NCCN) guideline concordance in terms of IMDC diagnostic workup and management across care settings. Results ED clinicians demonstrated greater adherence to NCCN guidelines than outpatient oncology providers. Of the 17 patients with IMDC, nine (52.94%) required ED management, with an average immunosuppressive therapy duration of 92.29 days, and only four (23.53%) resumed ICI therapy following IMDC resolution. Despite 88.24% of patients presenting with moderate-severe IMDC, 41.18% experienced symptoms for over a week before seeking medical care. Over 40% of patients with IMDC experienced concurrent immune-related adverse events (irAEs), with dermatitis and hepatitis being the most common. Conclusion Our findings reveal actionable targets for improving IMDC supportive management. Implementing standardized workflows and decision-support tools may strengthen evidence-based IMDC care, reduce treatment delays, and improve patient outcomes. Immune-related adverse events Immune-Mediated Diarrhea and Colitis Immune checkpoint inhibitors Real-world evidence Real-world practice Clinical guideline adherence Oncology practice Immunotherapy toxicity. Background Immune checkpoint inhibitors (ICIs) have transformed cancer therapy across tumor types and treatment settings. While generally well tolerated, ICIs can lead to immune-related adverse events (irAEs) that can affect any organ system and vary in severity. Immune-mediated Diarrhea and Colitis (IMDC) is the second most prevalent and clinically significant irAE after immune-mediated dermatitis [ 1 , 2 ] and is a common reason for discontinuing ICI therapy [ 3 , 4 ]. IMDC typically presents with symptoms of watery diarrhea, cramping, urgency, abdominal pain, blood and mucus in the stool, fever, and nocturnal bowel movements [ 5 ], often accompanied by abnormal endoscopic [ 6 – 9 ] and radiologic [ 10 ] findings and elevated fecal calprotectin and lactoferrin [ 11 ]. IMDC varies from mild to life-threatening in terms of severity and can develop rapidly [ 12 , 13 ] or several months after the last exposure to ICI therapy [ 14 ]. This variability in presentation and onset complicates the timely diagnosis and management of IMDC, making it a critical concern in oncology practice. The National Comprehensive Cancer Network (NCCN) has established evidence-based guidelines, detailed in Table 1 [ 5 ] for the classification, diagnostic workup, and management of IMDC, including corticosteroid initiation thresholds, use of second-line immunosuppressants, and criteria for ICI rechallenge. At present, little is known about how closely these guidelines are followed in everyday oncology practice or whether care delivery differs across clinical settings. Table 1 NCCN-Recommended IMDC Management Strategies by Grade IMDC Grade Grade 1 (Mild) Grade 2 (Moderate) Grades 3–4 (Severe) Classification 6 BMs/day above baseline, colitis symptoms, interference with ADLs, hemodynamic instability, hospitalization, serious complications. Workup Consider stool evaluation to rule out infectious etiology. Consider fecal lactoferrin/calprotectin. Stool evaluation to rule out infectious etiology. Consider fecal lactoferrin/calprotectin. Consider abdominal/ pelvic CT with contrast. Consider GI consultation. Stool evaluation to rule out infectious etiology. Consider fecal lactoferrin/calprotectin. Consider abdominal/ pelvic CT with contrast. Recommend GI consultation. Management Consider holding ICI therapy. Consider antidiarrheal agents and dietary modifications for 2–3 days for symptom relief. If no improvement, obtain infectious workup. If persistent/progressive symptoms, check lactoferrin/calprotectin. Hold ICI therapy. Administer systemic corticosteroids (prednisone/IV methylprednisolone 1–2 mg/kg/day). If no response to steroids, consider adding infliximab or vedolizumab. G3 – consider resuming anti-PD-1/anti-PD-L1 therapy after resolution of toxicity. G4 – permanently discontinue ICI therapy. Consider inpatient care for provision of supportive care. Note . Adapted from Thompson et al. (2023). Management of immunotherapy-related toxicities, version 1.2024, NCCN Clinical Practice Guidelines in Oncology. Journal of the National Comprehensive Cancer Network, 17 (3), 255–289. https://doi.org/10.6004/jnccn.2019.0013 This retrospective observational study evaluated IMDC management among patients treated with ICIs at a single NCI-designated comprehensive cancer center. The objective was to examine patterns in IMDC presentation, symptom reporting, diagnostic workup, and management, and to assess their alignment with current NCCN recommendations. By characterizing variability in real-world IMDC practices, this study seeks to support the development of standardized clinical workflows and proactive education strategies for both patients and oncology care teams to improve timely recognition and management of IMDC. Methods Study Design and Participants This retrospective observational study, conducted at an NCI-designated comprehensive cancer center in the Mountain West region of the United States, was designed to assess real-world IMDC diagnostic and management practices and evaluate their concordance with the NCCN practice guidelines. Routinely collected retrospective electronic health record data were analyzed without additional data manipulation. The University of Utah Institutional Review Board approved the study protocol (IRB #00176995) and granted a waiver of informed consent under 45 CFR 46.116(f) and 45 CFR 164.512(i)(2)(ii). Patient Identification We abstracted electronic health records of individuals with non-small cell lung cancer (NSCLC) who met the following criteria: aged 18 or older, with at least one documented exposure to ICI therapy, administered either as a single agent or in combination with other ICI or chemotherapy. Additionally, selected individuals had diagnostic codes suggestive of IMDC attached to their EHR encounters. These diagnostic codes included descriptions such as “toxic gastroenteritis and colitis,” “noninfective gastroenteritis and colitis,” “diarrhea,” and “abdominal pain” and were accompanied by a prescription or administration record for systemic corticosteroids or immunosuppressive agents, such as infliximab, or vedolizumab. The initial dataset included 417 patients, of whom 407 had received ICI therapy either alone or in combination with chemotherapy. Among these, 204 individuals had systemic corticosteroids (prednisone, methylprednisolone, infliximab, or vedolizumab) listed in their medication records. After excluding records without documented administration or prescription dates, we identified patients with diagnostic codes suggestive of IMDC and documented within 0–14 days of the initiation of immunosuppressive therapy. This filtering process resulted in 42 distinct patient records. Each case was then manually reviewed in the electronic health record (EHR) system using the patient’s medical record number. Patients who either experienced a different ICI-induced toxicity or had no clearly documented adverse event associated with immunosuppressive therapy during the relevant timeframe were excluded ( n = 25). This comprehensive review resulted in a final dataset of 17 individuals, all confirmed to have experienced IMDC, as verified by encounter notes, diagnostic imaging, and laboratory data. Data Collection and Variables EHR data were manually abstracted using a REDCap electronic data capture tool [ 15 ] hosted on the HIPAA-protected Box servers. Extracted variables included patient demographic characteristics, IMDC presenting symptoms and reporting patterns, initial diagnostic workup, and IMDC management details such as type, dose, and duration of immunosuppressive therapy. Guideline concordance was evaluated across key NCCN-defined domains: documentation of symptom grade; completion of recommended diagnostic workup (infectious stool studies, imaging, or endoscopy, as appropriate); corticosteroid initiation and dosing; and appropriate ICI hold, discontinuation, or rechallenge. To reduce misclassification and abstraction error, a second reviewer (KS) independently re-abstracted a random sample (target concordance ≥ 80%) [ 16 ], with 100% agreement achieved on reviewed key variables (presenting symptoms, diagnostic workup, patient outcomes). Analysis Descriptive statistics summarized patient characteristics, IMDC reporting, and management patterns. Analyses were descriptive and limited to available data. Missing values (e.g., unassessed laboratory or diagnostic tests) are indicated in the tables, and no data were imputed. Findings were interpreted thematically to identify practice variation and deviations from NCCN recommendations in both outpatient and ED care settings. Results Of the 17 patients with IMDC, 70.59% ( n = 12) were white males with a mean age of 66.8, either current or former smokers, and had metastatic lung cancer. A total of nine (52.94%) patients had an ECOG performance status of 0 or 1, while six (35.29%) had an ECOG of 2. Only two patients had an ECOG of 3 or 4. Most patients (70.59%) were overweight (BMI = 25–30) or obese (BMI > 30). More than half of the IMDC cohort received pembrolizumab either as monotherapy or in combination with chemotherapy (predominately carboplatin and pemetrexed). The remaining individuals received nivolumab or atezolizumab, either as a single agent or in combination with targeted chemotherapy. Over 40% ( n = 7) of individuals with IMDC had prior chemotherapy, while 17.65% had been previously treated with immune therapy, most receiving treatment with curative intent at initial diagnosis. Hypertension (76.47%), chronic pain (52.94%), obesity (29.41%), and depression (29.41%) were common comorbidities. Common systemic medications among the IMDC cohort included antihypertensive medications (70.59%), proton pump inhibitors (64.71%), opioid analgesics (58.82%), non-steroidal anti-inflammatory medications (52.94%), and antidepressants (41.18%). Notably, none of the patients had a history of inflammatory bowel disease, and only one was previously diagnosed with rheumatoid arthritis. Table 2 further details the demographic characteristics of the IMDC cohort. Table 2 Key Demographic Characteristics of Patients with IMDC (n = 17) Characteristic Categories Patients ( n = 17) Gender Male 12 (70.59%) Female 5 (29.41%) Age at IMDC Onset Range 47–85 Mean 66.76 Median 66 Ethnicity White or Caucasian 14 (82.35%) Black or African American 1 (5.88%) Hispanic 1 (5.88%) Other 1 (5.88%) Primary Health Insurance Commercial Health Plan 8 (47.06%) Medicare 5 (35.29%) Other 3 (17.65%) Medicaid 1 (5.88%) Smoking Status Former Smoker 11 (64.71%) Never Smoker 4 (23.53%) Current Smoker 2 (11.76%) Body Mass Index 18.5–25 5 (29.41%) 25–30 4 (23.53%) > 30 8 (47.06%) ECOG Status 0 4 (23.53%) 1 5 (29.41%) 2 6 (35.29%) 3 1 (5.88%) 4 1 (5.88%) NSCLC Type Adenocarcinoma 11 (64.71%) Squamous Cell 5 (29.41%) Poorly Differentiated 1 (5.88%) NSCLC Stage II 2 (11.76%) III 1 (5.88%) IV 14 (82.35%) ICI Regimen Pembrolizumab + Chemotherapy 7 (41.18%) Pembrolizumab Monotherapy 3 (17.65%) Nivolumab Monotherapy 2 (11.76%) Atezolizumab + Chemotherapy 2 (11.76%) Atezolizumab Monotherapy 1 (5.88%) Prior Chemotherapy Exposure Yes 7 (41.18%) No 10 (58.82%) Table 2 continued Characteristic Categories Patients ( n = 17) Prior ICI Therapy Exposure Yes 3 (17.65%) No 14 (82.35%) Systemic Medications Antihypertensive Medications 12 (70.59%) Proton Pump Inhibitors 11 (64.71%) Opioid Analgesics 10 (58.82%) NSAIDs 9 (52.94%) Antidepressants 7 (41.18%) Antibiotics 5 (29.41%) Anxiolytics 5 (29.41%) Psychotropic Medications 3 (17.65%) Vitamin B Supplements 3 (17.65%) Vitamin D Supplements 2 (11.76%) Antidiabetic Medications 2 (11.76%) Documented Comorbidities Hypertension 13 (76.47%) Chronic Pain 9 (52.94%) Obesity 5 (29.41%) Depression 5 (29.41%) Anxiety 4 (23.53%) Diabetes 4 (23.53%) Weight Loss 2 (11.76%) Decreased Mobility 2 (11.76%) Hearing Loss 1 (5.88%) Fifteen (38.46%) out of the 17 patients were exposed to ICI therapy for at least 30 days, with 35.29% receiving ICI therapy for over 180 days. While 76.47% of patients experienced IMDC symptoms within 90 days of their last ICI infusion, four patients had delayed-onset IMDC, occurring up to 370 days after their final ICI exposure. In terms of IMDC symptom reporting, 13 out of 17 patients reported IMDC symptoms within 21 days of onset. However, four individuals had untreated low-grade diarrhea for extended periods, in some cases lasting as long as one year. The outpatient oncology clinic and emergency department (ED) were the primary settings for the initial evaluation of IMDC, with 64.71% ( n = 11) and 23.53% ( n = 4) of patients assessed in these settings, respectively. However, five of 13 patients with IMDC initially seen in an outpatient setting were later assessed at the ED. Only two patients contacted the outpatient oncology triage line to report their symptoms. All patients reported diarrhea as their chief complaint, with 88.24% presenting with moderate or severe IMDC per NCCN grading criteria. Other common symptoms included weight loss (41.18%) and nausea and/or vomiting (35.29%), while blood-tinged stools were reported by only 11.76% of patients. Additionally, 47.06% of patients had attempted an unsuccessful trial of the over-the-counter antidiarrheal agent Imodium (loperamide) before seeking medical care. Notably, 41.18% of patients developed other concurrent irAEs, with autoimmune dermatitis and hepatitis being the most prevalent. Table 3 provides an overview of IMDC presenting symptoms and reporting patterns. Table 3 Clinical Presentation and Reporting Patterns among Patients with IMDC (n = 17) Parameter Categories Patients ( n = 17) ICI therapy exposure duration (days) 180 6 (35.29%) Days elapsed between last ICI dose and IMDC symptom onset 90 4 (23.53%) Days elapsed between IMDC symptom onset and report 21 4 (23.53%) Setting of Initial IMDC evaluation Outpatient Clinic Visit 11 (64.71%) ED Evaluation 4 (23.53%) Oncology Triage 2 (11.76%) IMDC presenting symptoms Diarrhea 17 (100.00%) Weight Loss 7 (41.18%) Nausea and/or Vomiting 6 (35.29%) Abdominal Pain 5 (29.41%) Nocturnal Diarrhea 4 (23.53%) Stool Incontinence 3 (17.65%) Blood in Stool 2 (11.76%) IMDC severity (based on number of bowel movements/day) Mild ( 6) 7 (41.18%) Trial of Imodium Yes 8 (47.06%) No/Unknown 9 (52.94%) Concurrent irAEs Yes 7 (41.18%) No/Unknown 10 (58.82%) Overall, 52.94% ( n = 9) of patients with IMDC were evaluated at the ED, four at initial onset and five for subsequent symptom management. Three out of four patients (75%) initially evaluated at the ED were started on the appropriate dose of systemic corticosteroids, with an average dose of 0.89 mg/kg/day, and two had diagnostic imaging and stool tests ordered. One patient, seen at a different ED location, had incomplete records on the extent of IMDC workup but was initiated on appropriate corticosteroid therapy. Additionally, two patients with severe symptoms initially seen in the oncology clinic were referred to the ED the same day, where they received diagnostic imaging, stool marker assessments, and immunosuppression consistent with NCCN recommendations. Only one ED-assessed patient did not receive adequate management, instead being given fluids, electrolytes, and Imodium despite severe symptoms. In contrast, of the 13 patients initially evaluated in the outpatient setting, only one had stool markers, and diagnostic imaging ordered the same day (excluding the two referred to the ED). However, three of these patients had undergone comprehensive imaging, including scans of the abdomen and pelvis, shortly before the onset of IMDC symptoms. Although 11 of 13 individuals (84.62%) evaluated in the oncology clinic reported moderate or severe symptoms, only four (30.78%) were started on systemic corticosteroids the same day, all at a dose below the 1 mg/kg/day recommended by the NCCN (mean = 0.64 mg/kg/day). The remaining seven patients managed in an outpatient setting were initially advised to use Imodium, though all eventually required systemic corticosteroids, and one case necessitated infliximab. Additionally, three individuals assessed in the oncology outpatient clinics received a dose of ICI therapy despite reporting moderate IMDC symptoms. Table 4 summarizes adherence to NCCN guideline–recommended practices across ED and outpatient oncology settings. Table 4 Summary of Adherence to NCCN Guidelines by Clinical Setting (Initial Presentation) Symptom Grading Documented Infectious Workup (C. difficile ± stool markers) Steroid Dosing (≥ 1 mg/kg prednisone eq.) ICI Hold/ Rechallenge (per guidelines) Emergency Department (n = 4) 4 (100%) 2 (50%) 3 (75%) 4 (100%) All ICIs appropriately held; 2 later rechallenged after resolution Outpatient Oncology Clinic (n = 13) 11 (84.6%) 1 (7.7%) same day + 3 (23%) had recent imaging 4 (30.8%) same-day start < 1 mg/kg 10 (76.9%) ICI held appropriately; 3 received dose despite symptoms Note . Adherence reflects initial presentation only. Two outpatients were later referred to the ED for guideline-concordant management and are not double-counted here. Data derived from institutional electronic health records (n = 17). Among the eight patients tested for C. difficile and other common pathogens, all had negative stool findings. In contrast, all patients who had inflammatory stool markers assessed had elevated calprotectin (5/5) and positive lactoferrin (4/4). Of the seven CT scans conducted as part of the IMDC evaluation or shortly before symptom onset, four revealed bowel wall thickening and edema. Only two patients (11.76%) underwent diagnostic colonoscopy, with one revealing lymphocytic colitis and the other showing no abnormal findings. Nearly half (47.06%) of patients were started on systemic corticosteroids the day they first reported IMDC symptoms. The remaining 52.94%, predominantly those with mild to moderate IMDC, were initially managed conservatively with Imodium and dietary modifications before progressing to steroid therapy. Oral prednisone was the initial therapy in 76.47% of cases, while the remaining 23.53% received intravenous or oral methylprednisolone. Bactrim was prescribed in 47.06% of cases for P. jirovecii pneumonia prophylaxis, and 76.47% of patients were on concurrent proton pump inhibitor therapy, either initiated with steroids (11.76%) or continued from an existing prescription (64.71%). Imodium was recommended in 88.24% of cases as an adjunct for symptom management. While only one patient required additional immunosuppression, first with infliximab and later with vedolizumab, 29.41% of patients experienced refractory diarrhea after initiating steroid taper, requiring a dose increase. Overall, 88.24% of patients remained on immunosuppressive therapy for at least 30 days, with only two patients undergoing rapid steroid taper. At the time of IMDC diagnosis, 58.82% had their ICI therapy suspended or permanently discontinued, while four patients continued ICI treatment either until symptom progression or, in mild cases, while on immunosuppressive therapy. Only four patients (23.53%) resumed ICI therapy upon IMDC resolution, all receiving the same ICI as before. One individual who developed IMDC following the completion of ICI therapy, continued with surveillance following IMDC resolution. Of the 12 patients (70.59%) who permanently discontinued ICI therapy, three (25%) transitioned to Hospice, two (16.67%) experienced disease progression and were switched to chemotherapy, one patient (8.33%) who was on a combination ICI plus targeted agent regimen continued the targeted agent without resuming the ICI, four individuals (33.33%) whose disease remained stable off treatment transitioned to surveillance. The remaining two patients were changed to alternative non-ICI therapies. Table 5 provides an overview of IMDC diagnostic workup and clinical course. Table 5 Diagnostic Workup, Therapeutic Management, and Clinical Course of IMDC (n = 17) Parameter Categories Patients ( n = 17) C. difficile and stool pathogens Assessed 8 (47.06%) Not assessed 9 (52.94%) Stool calprotectin Assessed 5 (29.41%) Not assessed 12 (70.59%) Stool lactoferrin Assessed 4 (23.53%) Not assessed 13 (76.47%) Abdominal imaging Ordered 7 (41.18%) Not ordered 10 (58.82%) Gastroenterology consult Requested 2 (11.76%) Not requested 15 (88.24%) Required ED management Yes 9 (52.94%) No 8 (47.06%) Days elapsed between initial evaluation and steroid therapy initiation 0 8 (47.06%) 1–7 6 (35.29%) > 7 3 (17.65%) Initial corticosteroid type and route Prednisone PO 13 (76.47%) Methylprednisolone IV 3 (17.65%) Methylprednisolone PO 1 (5.88%) Initial corticosteroid dose < 1 mg/kg/day 7 (41.18%) 1 mg/kg/day 8 (47.06%) 2 mg/kg/day 2 (11.76%) Infliximab or vedolizumab immunosuppression required? Yes 1 (5.88%) No 16 (94.12%) Refractory diarrhea following steroid taper? Yes 5 (29.41%) No 12 (70.59%) Immunosuppressive therapy duration (mean = 92.29 days) 90 days 2 (11.76%) Supportive therapy Bactrim 8 (47.06%) Proton Pump Inhibitor 13 (76.47%) Imodium 15 (88.24%) Was ICI therapy interrupted at IMDC onset? Yes 10 (58.82%) No 4 (23.53%) Not applicable 3 (17.65%) Was ICI therapy resumed after IMDC resolution Yes 10 (58.82%) No 4 (23.53%) Table 5 continued Parameter Categories Patients ( n = 17) Not applicable 3 (17.65%) Was clinical rationale provided for discontinuing/resuming ICI therapy? Yes 11 (64.71%) No 6 (35.29%) Were NCCN guidelines referenced in clinical notes? Yes 0 (0.00%) No 17 (100.00%) * Note . “Not applicable” includes two patients whose ICI therapy was held later the same day after ED referral and one patient who developed IMDC following completion of ICI therapy. Discussion Results Summary and Interpretation of Findings We observed significant variation in diagnostic workup and management of IMDC. Patients evaluated at the ED generally received care most consistent with NCCN clinical guidelines [ 5 ], whereas seven out of 13 patients initially seen in the outpatient clinic were started on Imodium before progressing to systemic corticosteroids, and three received an additional dose of ICI therapy despite reporting moderate IMDC symptoms. The discrepancies between ED and outpatient management approaches may be explained by differences in resources available to clinicians in each setting. Additionally, ED clinicians may adhere more strictly to clinical algorithms, whereas clinicians in oncology outpatient clinics may have more flexibility in tailoring management strategies to individual patient needs and goals of care. Delayed IMDC management in outpatient clinics may also occur when IMDC symptoms are confused with chemotherapy-related toxicities in patients receiving concurrent ICI and chemotherapy, leading to missed guideline-recommended interventions and complicating timely oncology triage. Consistent with prior studies [ 17 , 18 ], fecal calprotectin and lactoferrin were reliable markers of IMDC, showing abnormalities in all affected individuals, while abdominal imaging and endoscopic evaluation findings were less consistent, with four out of seven CT scans and one out of two colonoscopies revealing abnormalities consistent with IMDC. Delayed onset IMDC, occurring > 90 days after the last ICI exposure, was observed in 23.53% of patients, reinforcing the NCCN recommendation to follow patients previously treated with ICIs for at least two years [ 5 ]. Hypertension was present in over 76% ( n = 13) of individuals who experienced IMDC. Previous studies examining the relationship between common comorbidities and the incidence of immune-related adverse events (irAEs) have also identified hypertension as a potential risk factor [ 19 – 21 ]. Additionally, 10 out of 17 patients had opioid analgesics and nine had non-steroidal anti-inflammatory drugs (NSAIDs) on their medication list. This finding aligns with studies reporting that opioid analgesics [ 22 , 23 ] and NSAIDs [ 19 ] may have immunosuppressive effects, potentially increasing the risk of irAEs. In line with prior reports [ 24 , 25 ], 76.47% of patients remained on immunosuppressive therapy for 30–90 days, with a few outliers either requiring extended immunosuppression or responding to a rapid taper. Notably, 41.18% of patients with IMDC were diagnosed with co-occurring irAEs, predominately immune-mediated dermatitis. This finding closely aligns with previously published studies [ 5 , 26 ], highlighting the need for heightened vigilance in monitoring for additional irAEs in patients with IMDC and reinforcing the importance of comprehensive management strategies to address concurrent irAEs. Lastly, our findings revealed that only two out of 17 patients (11.76%) reported their IMDC symptoms directly to their oncology team. Moreover, 41.18% of patients experienced symptoms for more than seven days before seeking medical evaluation. This delay in symptom reporting underscores the need for improved patient education on common irAE presentations and the importance of timely symptom reporting to minimize the risk of complications. Strengths and Limitations By focusing on the diagnostic workup and management of IMDC in a real-world clinical setting, this research adds valuable insights into the practical management of IMDC, which has not been extensively studied. The in-depth qualitative review of patient records allows for a nuanced understanding of symptom presentation, diagnostic workup, and clinical decision-making, enhancing our understanding of IMDC beyond what quantitative studies alone can reveal. However, several limitations must also be acknowledged. First, the study was conducted at a single site, which may limit the generalizability of its findings. Second, the absence of a comparison group prevents assessment of whether specific demographic and clinical characteristics correlate with an increased risk of IMDC. Third, the relatively small patient cohort ( n = 17) limits the statistical power of the analysis and may introduce bias in capturing the full range of IMDC presentations and outcomes. The small sample size also reduces the ability to perform detailed subgroup analyses, which could have provided more granular insights into specific treatment approaches and patient outcomes. Conclusion Our findings revealed significant variation in the diagnostic workup and management of IMDC, with clinicians in the emergency department adhering more closely to clinical guidelines than those in outpatient settings. These insights underscore the need for a better understanding of real-world IMDC management and the factors contributing to deviations from established guidelines. Future research should focus on conducting large, multisite studies to gain a more comprehensive understanding of IMDC across diverse patient populations and clinical settings. A larger sample size would also enable more detailed subgroup analyses, potentially providing valuable insights into specific risk factors associated with IMDC. Additionally, focused group interviews with oncology and acute care clinicians could help uncover the reasons for deviations from clinical guidelines and lay the foundation for expert panels to review, update, and disseminate best practices. Future work should also incorporate structured implementation strategies, such as standardized triage pathways, embedded stool test order panels, and EHR prompts for IMDC grading, to support prompt, guideline-concordant care. Automated patient messaging systems to flag early-onset diarrhea symptoms and IMDC checklists within oncology clinics may further streamline symptom identification and management, improving consistency across care settings. Collectively, these workflow-integrated approaches can strengthen adherence to evidence-based IMDC management, support more timely and consistent diagnosis and treatment, and ultimately enhance the safety of immunotherapy delivery. Relevance to Supportive Oncology Timely recognition and evidence-based management of IMDC are essential to prevent avoidable symptom burden, emergency care utilization, and treatment interruptions. Identifying workflow gaps and opportunities for standardized triage and decision-support can strengthen supportive care processes for patients receiving immunotherapy. Abbreviations ICI (Immune Checkpoint Inhibitor) IMDC (Immune-Mediated Diarrhea and Colitis) NCI (National Cancer Institute) EHR (Electronic Health Record) NCCN (National Comprehensive Cancer Network) ED (Emergency Department) irAEs (Immune-Related Adverse Events) Declarations Funding None. Competing interests None. Ethics approval and consent to participate This retrospective study was conducted in accordance with the ethical principles of the Declaration of Helsinki and all applicable regulatory requirements. The University of Utah Institutional Review Board approved the study protocol (IRB #00176995) and granted a waiver of informed consent under 45 CFR 46.116(f) and 45 CFR 164.512(i)(2)(ii). Consent for publication Not applicable. Availability of data and materials De-identified data available upon reasonable request. Author contributions Natalya Alekhina: Conceptualization, Methodology, Data Preprocessing, Formal Analysis, Writing – Original Draft, Writing – Review and Editing Kathi Mooney: Conceptualization, Methodology, Writing – Review and Editing, Supervision Katherine Sward: Conceptualization, Methodology, Data Preprocessing, Writing – Review and Editing Bob Wong: Methodology, Formal Analysis, Writing – Review and Editing Wallace Akerley: Methodology, Writing – Review and Editing. Data Availability De-identified data available upon reasonable request. References Martins F, Sofiya L, Sykiotis GP, et al. Adverse effects of immune-checkpoint inhibitors: Epidemiology, management and surveillance. Nat Rev Clin Oncol. 2019;16(9):563–580. https://doi.org/10.1038/s41571-019-0218-0 Som A, Mandaliya R, Alsaadi D, et al. Immune checkpoint inhibitor-induced colitis: A comprehensive review. 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Nivolumab-induced immune-mediated colitis: An ulcerative colitis look-alike: Report of new cases and review of the literature. Int J Colorectal Dis. 2019;34(5):861–865. https://doi.org/10.1007/s00384-019-03268-4 Shivaji UN, Jeffery L, Gui X, et al. Immune checkpoint inhibitor-associated gastrointestinal and hepatic adverse events and their management. Ther Adv Gastroenterol. 2019;12:1–15. https://doi.org/10.1177/1756284819884196 Singh BP, Marshall JL, He AR. Workup and management of immune-mediated colitis in patients treated with immune checkpoint inhibitors. Oncologist. 2020;25(3):197–202. https://doi.org/10.1634/theoncologist.2018-0304 Wardill HR, Chan RJ, Chan A, et al. Dual contribution of the gut microbiome to immunotherapy efficacy and toxicity: Supportive care implications and recommendations. Support Care Cancer. 2022;30(8):6369–6373. https://doi.org/10.1007/s00520-022-06948-0 Park H, Hatabu H, Ricciuti B, et al. Immune-related adverse events on body CT in patients with small-cell lung cancer treated with immune-checkpoint inhibitors. Eur J Radiol. 2020;132:109275. https://doi.org/10.1016/j.ejrad.2020.109275 Rubio MG, Amo-Mensah K, Gray JM, et al. Fecal lactoferrin accurately reflects mucosal inflammation in inflammatory bowel disease. World J Gastrointest Pathophysiol. 2019;10(5):54–63. https://doi.org/10.4291/wjgp.v10.i5.54 Losurdo G, Angelillo D, Favia N, et al. Checkpoint inhibitor-induced colitis: An update. Biomedicines. 2023;11(5):1496. https://doi.org/10.3390/biomedicines11051496 Lukin R, Ciner A. Fulminant immune-related colitis after dual checkpoint inhibitor therapy: Case report. Immunotherapy. 2024;16(14–15):943–948. https://doi.org/10.1080/1750743X.2024.2386234 Yan T, Yu L, Zhang J, et al. Achilles’ heel of currently approved immune checkpoint inhibitors: Immune-related adverse events. Front Immunol. 2024;15:1292122. https://doi.org/10.3389/fimmu.2024.1292122 Harris PA, Taylor R, Minor BL, et al. The REDCap consortium: Building an international community of software platform partners. J Biomed Inform. 2019;95:103208. https://doi.org/10.1016/j.jbi.2019.103208 Kwiecien R, Kopp-Schneider A, Blettner M. Concordance analysis. Dtsch Arztebl Int. 2011;108(30):515–521. https://doi.org/10.3238/arztebl.2011.0515 Abu-Sbeih H, Herrera LN, Tang T, et al. Impact of antibiotic therapy on the development and response to treatment of immune checkpoint inhibitor-mediated diarrhea and colitis. J Immunother Cancer. 2019;7(1):242. https://doi.org/10.1186/s40425-019-0714-x Gong Z, Wang Y. Immune checkpoint inhibitor-mediated diarrhea and colitis: A clinical review. JCO Oncol Pract. 2020;16(8):453–461. https://doi.org/10.1200/OP.20.00002 Chennamadhavuni A, Abushahin L, Jin N, et al. Risk factors and biomarkers for immune-related adverse events: A practical guide to identifying high-risk patients and rechallenging immune checkpoint inhibitors. Front Immunol. 2022;13:779691. https://doi.org/10.3389/fimmu.2022.779691 Gao J, Zhang P, Tang M, et al. Predictors of immune checkpoint inhibitor-related adverse events in older patients with lung cancer: A prospective real-world analysis. J Cancer Res Clin Oncol. 2023;149(11):8993–9006. https://doi.org/10.1007/s00432-023-04792-1 Kartolo A, Sattar J, Sahai V, et al. Predictors of immunotherapy-induced immune-related adverse events. Curr Oncol. 2018;25(5):e403–e410. https://doi.org/10.3747/co.25.4047 Hussain N, Naeem M, Pinato DJ. Concomitant medications and immune checkpoint inhibitor therapy for cancer: Causation or association? Hum Vaccin Immunother. 2021;17(1):55–61. https://doi.org/10.1080/21645515.2020.1769398 Kostine M, Mauric E, Tison A, et al. Baseline co-medications may alter the anti-tumoural effect of checkpoint inhibitors as well as the risk of immune-related adverse events. Eur J Cancer. 2021;157:474–484. https://doi.org/10.1016/j.ejca.2021.08.036 Burla J, Bluemel S, Biedermann L, et al. Retrospective analysis of treatment and complications of immune checkpoint inhibitor-associated colitis: Histological ulcerations as potential predictor for a steroid-refractory disease course. Inflamm Intest Dis. 2020;5(3):109–116. https://doi.org/10.1159/000507579 Favara DM, Spain L, Au L, et al. Five-year review of corticosteroid duration and complications in the management of immune checkpoint inhibitor-related diarrhoea and colitis in advanced melanoma. ESMO Open. 2020;5(4):e000585. https://doi.org/10.1136/esmoopen-2019-000585 Molina GE, Allen IM, Hughes MS, et al. Prognostic implications of co-occurring dermatologic and gastrointestinal toxicity from immune checkpoint inhibition therapy for advanced malignancies: A retrospective cohort study. J Am Acad Dermatol. 2020;82(3):743–746. https://doi.org/10.1016/j.jaad.2019.07.049 Additional Declarations No competing interests reported. Cite Share Download PDF Status: Published Journal Publication published 28 Mar, 2026 Read the published version in Supportive Care in Cancer → Version 1 posted Editorial decision: Revision requested 20 Feb, 2026 Reviews received at journal 16 Feb, 2026 Reviewers agreed at journal 29 Jan, 2026 Reviews received at journal 21 Jan, 2026 Reviewers agreed at journal 20 Jan, 2026 Reviewers invited by journal 14 Jan, 2026 Editor assigned by journal 27 Dec, 2025 Submission checks completed at journal 14 Dec, 2025 First submitted to journal 02 Dec, 2025 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. 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16:25:50","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1454097,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-8264047/v1/4b49a3c5-1885-473c-ab54-015690931e6c.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Real-World Management and Outcomes of Immune-Mediated Diarrhea and Colitis: Gaps in Guideline Adherence and Opportunities for Implementation","fulltext":[{"header":"Background","content":"\u003cp\u003eImmune checkpoint inhibitors (ICIs) have transformed cancer therapy across tumor types and treatment settings. While generally well tolerated, ICIs can lead to immune-related adverse events (irAEs) that can affect any organ system and vary in severity. Immune-mediated Diarrhea and Colitis (IMDC) is the second most prevalent and clinically significant irAE after immune-mediated dermatitis [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e] and is a common reason for discontinuing ICI therapy [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e, \u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eIMDC typically presents with symptoms of watery diarrhea, cramping, urgency, abdominal pain, blood and mucus in the stool, fever, and nocturnal bowel movements [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e], often accompanied by abnormal endoscopic [\u003cspan additionalcitationids=\"CR7 CR8\" citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e–\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e] and radiologic [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e] findings and elevated fecal calprotectin and lactoferrin [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e]. IMDC varies from mild to life-threatening in terms of severity and can develop rapidly [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e, \u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e] or several months after the last exposure to ICI therapy [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e]. This variability in presentation and onset complicates the timely diagnosis and management of IMDC, making it a critical concern in oncology practice.\u003c/p\u003e \u003cp\u003eThe National Comprehensive Cancer Network (NCCN) has established evidence-based guidelines, detailed in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e] for the classification, diagnostic workup, and management of IMDC, including corticosteroid initiation thresholds, use of second-line immunosuppressants, and criteria for ICI rechallenge. At present, little is known about how closely these guidelines are followed in everyday oncology practice or whether care delivery differs across clinical settings.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e\u003cdiv class=\"gridtable\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eNCCN-Recommended IMDC Management Strategies by Grade\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e\u003ccolgroup cols=\"4\"\u003e\u003c/colgroup\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eIMDC Grade\u003c/p\u003e \u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eGrade 1 \u003c/p\u003e \u003cp\u003e(Mild)\u003c/p\u003e \u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eGrade 2 (Moderate)\u003c/p\u003e \u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eGrades 3–4\u003c/p\u003e \u003cp\u003e(Severe)\u003c/p\u003e \u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eClassification\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u0026lt; 4 bowel movements (BMs)/day above baseline and no colitis symptoms.\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4–6 BMs/day above baseline colitis symptoms, not interfering with activities of daily living (ADLs).\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u0026gt; 6 BMs/day above baseline, colitis symptoms, interference with ADLs, hemodynamic instability, hospitalization, serious complications.\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eWorkup\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eConsider stool evaluation to rule out infectious etiology. Consider fecal lactoferrin/calprotectin.\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eStool evaluation to rule out infectious etiology. Consider fecal lactoferrin/calprotectin. Consider abdominal/ pelvic CT with contrast. Consider GI consultation.\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eStool evaluation to rule out infectious etiology. Consider fecal lactoferrin/calprotectin. Consider abdominal/ pelvic CT with contrast. Recommend GI consultation.\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eManagement\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eConsider holding ICI therapy. Consider antidiarrheal agents and dietary modifications for 2–3 days for symptom relief. If no improvement, obtain infectious workup. If persistent/progressive symptoms, check lactoferrin/calprotectin.\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eHold ICI therapy. Administer systemic corticosteroids (prednisone/IV methylprednisolone 1–2 mg/kg/day). If no response to steroids, consider adding infliximab or vedolizumab.\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eG3 – consider resuming anti-PD-1/anti-PD-L1 therapy after resolution of toxicity. G4 – permanently discontinue ICI therapy.\u003c/p\u003e \u003cp\u003eConsider inpatient care for provision of supportive care.\u003c/p\u003e \u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003ctfoot\u003e\u003ctr\u003e\u003ctd colspan=\"4\"\u003e\u003cb\u003eNote\u003c/b\u003e. Adapted from Thompson et al. (2023). Management of immunotherapy-related toxicities, version 1.2024, NCCN Clinical Practice Guidelines in Oncology. \u003cem\u003eJournal of the National Comprehensive Cancer Network, 17\u003c/em\u003e(3), 255–289. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.6004/jnccn.2019.0013\u003c/span\u003e\u003cspan address=\"10.6004/jnccn.2019.0013\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tfoot\u003e\u003c/table\u003e\u003c/div\u003e \u003cp\u003e\u003c/p\u003e \u003cp\u003eThis retrospective observational study evaluated IMDC management among patients treated with ICIs at a single NCI-designated comprehensive cancer center. The objective was to examine patterns in IMDC presentation, symptom reporting, diagnostic workup, and management, and to assess their alignment with current NCCN recommendations. By characterizing variability in real-world IMDC practices, this study seeks to support the development of standardized clinical workflows and proactive education strategies for both patients and oncology care teams to improve timely recognition and management of IMDC.\u003c/p\u003e "},{"header":"Methods","content":"\u003cp\u003eStudy Design and Participants\u003c/p\u003e\u003cp\u003e This retrospective observational study, conducted at an NCI-designated comprehensive cancer center in the Mountain West region of the United States, was designed to assess real-world IMDC diagnostic and management practices and evaluate their concordance with the NCCN practice guidelines. Routinely collected retrospective electronic health record data were analyzed without additional data manipulation. The University of Utah Institutional Review Board approved the study protocol (IRB #00176995) and granted a waiver of informed consent under 45 CFR 46.116(f) and 45 CFR 164.512(i)(2)(ii).\u003c/p\u003e\u003cp\u003ePatient Identification\u003c/p\u003e\u003cp\u003eWe abstracted electronic health records of individuals with non-small cell lung cancer (NSCLC) who met the following criteria: aged 18 or older, with at least one documented exposure to ICI therapy, administered either as a single agent or in combination with other ICI or chemotherapy. Additionally, selected individuals had diagnostic codes suggestive of IMDC attached to their EHR encounters. These diagnostic codes included descriptions such as “toxic gastroenteritis and colitis,” “noninfective gastroenteritis and colitis,” “diarrhea,” and “abdominal pain” and were accompanied by a prescription or administration record for systemic corticosteroids or immunosuppressive agents, such as infliximab, or vedolizumab.\u003c/p\u003e\u003cp\u003eThe initial dataset included 417 patients, of whom 407 had received ICI therapy either alone or in combination with chemotherapy. Among these, 204 individuals had systemic corticosteroids (prednisone, methylprednisolone, infliximab, or vedolizumab) listed in their medication records. After excluding records without documented administration or prescription dates, we identified patients with diagnostic codes suggestive of IMDC and documented within 0–14 days of the initiation of immunosuppressive therapy. This filtering process resulted in 42 distinct patient records. Each case was then manually reviewed in the electronic health record (EHR) system using the patient’s medical record number. Patients who either experienced a different ICI-induced toxicity or had no clearly documented adverse event associated with immunosuppressive therapy during the relevant timeframe were excluded (\u003cem\u003en\u003c/em\u003e = 25). This comprehensive review resulted in a final dataset of 17 individuals, all confirmed to have experienced IMDC, as verified by encounter notes, diagnostic imaging, and laboratory data.\u003c/p\u003e\u003cp\u003eData Collection and Variables\u003c/p\u003e\u003cp\u003eEHR data were manually abstracted using a REDCap electronic data capture tool [\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e] hosted on the HIPAA-protected Box servers. Extracted variables included patient demographic characteristics, IMDC presenting symptoms and reporting patterns, initial diagnostic workup, and IMDC management details such as type, dose, and duration of immunosuppressive therapy. Guideline concordance was evaluated across key NCCN-defined domains: documentation of symptom grade; completion of recommended diagnostic workup (infectious stool studies, imaging, or endoscopy, as appropriate); corticosteroid initiation and dosing; and appropriate ICI hold, discontinuation, or rechallenge. To reduce misclassification and abstraction error, a second reviewer (KS) independently re-abstracted a random sample (target concordance ≥ 80%) [\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e], with 100% agreement achieved on reviewed key variables (presenting symptoms, diagnostic workup, patient outcomes).\u003c/p\u003e\u003cp\u003eAnalysis\u003c/p\u003e\u003cp\u003eDescriptive statistics summarized patient characteristics, IMDC reporting, and management patterns. Analyses were descriptive and limited to available data. Missing values (e.g., unassessed laboratory or diagnostic tests) are indicated in the tables, and no data were imputed. Findings were interpreted thematically to identify practice variation and deviations from NCCN recommendations in both outpatient and ED care settings.\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003eOf the 17 patients with IMDC, 70.59% (\u003cem\u003en\u003c/em\u003e\u0026thinsp;=\u0026thinsp;12) were white males with a mean age of 66.8, either current or former smokers, and had metastatic lung cancer. A total of nine (52.94%) patients had an ECOG performance status of 0 or 1, while six (35.29%) had an ECOG of 2. Only two patients had an ECOG of 3 or 4. Most patients (70.59%) were overweight (BMI\u0026thinsp;=\u0026thinsp;25\u0026ndash;30) or obese (BMI\u0026thinsp;\u0026gt;\u0026thinsp;30).\u003c/p\u003e \u003cp\u003eMore than half of the IMDC cohort received pembrolizumab either as monotherapy or in combination with chemotherapy (predominately carboplatin and pemetrexed). The remaining individuals received nivolumab or atezolizumab, either as a single agent or in combination with targeted chemotherapy. Over 40% (\u003cem\u003en\u003c/em\u003e\u0026thinsp;=\u0026thinsp;7) of individuals with IMDC had prior chemotherapy, while 17.65% had been previously treated with immune therapy, most receiving treatment with curative intent at initial diagnosis.\u003c/p\u003e \u003cp\u003eHypertension (76.47%), chronic pain (52.94%), obesity (29.41%), and depression (29.41%) were common comorbidities. Common systemic medications among the IMDC cohort included antihypertensive medications (70.59%), proton pump inhibitors (64.71%), opioid analgesics (58.82%), non-steroidal anti-inflammatory medications (52.94%), and antidepressants (41.18%). Notably, none of the patients had a history of inflammatory bowel disease, and only one was previously diagnosed with rheumatoid arthritis. Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e2\u003c/span\u003e further details the demographic characteristics of the IMDC cohort.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eKey Demographic Characteristics of Patients with IMDC (n\u0026thinsp;=\u0026thinsp;17)\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"3\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eCharacteristic\u003c/em\u003e\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cem\u003eCategories\u003c/em\u003e\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cem\u003ePatients\u003c/em\u003e (\u003cem\u003en\u003c/em\u003e\u0026thinsp;=\u0026thinsp;17)\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e\u003cb\u003eGender\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMale\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e12 (70.59%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eFemale\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5 (29.41%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"2\" rowspan=\"3\"\u003e \u003cp\u003e\u003cb\u003eAge at IMDC Onset\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eRange\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e47\u0026ndash;85\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMean\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e66.76\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMedian\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e66\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"3\" rowspan=\"4\"\u003e \u003cp\u003e\u003cb\u003eEthnicity\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eWhite or Caucasian\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e14 (82.35%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eBlack or African American\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1 (5.88%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eHispanic\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1 (5.88%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eOther\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1 (5.88%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"3\" rowspan=\"4\"\u003e \u003cp\u003e\u003cb\u003ePrimary Health Insurance\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eCommercial Health Plan\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e8 (47.06%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMedicare\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5 (35.29%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eOther\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3 (17.65%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMedicaid\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1 (5.88%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"2\" rowspan=\"3\"\u003e \u003cp\u003e\u003cb\u003eSmoking Status\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eFormer Smoker\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e11 (64.71%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNever Smoker\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4 (23.53%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eCurrent Smoker\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2 (11.76%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"2\" rowspan=\"3\"\u003e \u003cp\u003e\u003cb\u003eBody Mass Index\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e18.5\u0026ndash;25\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5 (29.41%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e25\u0026ndash;30\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4 (23.53%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u0026gt;\u0026thinsp;30\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e8 (47.06%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"4\" rowspan=\"5\"\u003e \u003cp\u003e\u003cb\u003eECOG Status\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4 (23.53%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5 (29.41%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e6 (35.29%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1 (5.88%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1 (5.88%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"2\" rowspan=\"3\"\u003e \u003cp\u003e\u003cb\u003eNSCLC Type\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAdenocarcinoma\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e11 (64.71%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eSquamous Cell\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5 (29.41%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePoorly Differentiated\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1 (5.88%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"2\" rowspan=\"3\"\u003e \u003cp\u003e\u003cb\u003eNSCLC Stage\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eII\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2 (11.76%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eIII\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1 (5.88%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eIV\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e14 (82.35%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"4\" rowspan=\"5\"\u003e \u003cp\u003e\u003cb\u003eICI Regimen\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePembrolizumab\u0026thinsp;+\u0026thinsp;Chemotherapy\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e7 (41.18%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePembrolizumab Monotherapy\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3 (17.65%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNivolumab Monotherapy\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2 (11.76%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAtezolizumab\u0026thinsp;+\u0026thinsp;Chemotherapy\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2 (11.76%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAtezolizumab Monotherapy\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1 (5.88%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e\u003cb\u003ePrior Chemotherapy Exposure\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e7 (41.18%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e10 (58.82%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003econtinued\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"3\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eCharacteristic\u003c/em\u003e\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cem\u003eCategories\u003c/em\u003e\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cem\u003ePatients\u003c/em\u003e (\u003cem\u003en\u003c/em\u003e\u0026thinsp;=\u0026thinsp;17)\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e\u003cb\u003ePrior ICI Therapy Exposure\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e3 (17.65%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e14 (82.35%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"10\" rowspan=\"11\"\u003e \u003cp\u003e\u003cb\u003eSystemic Medications\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAntihypertensive Medications\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e12 (70.59%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eProton Pump Inhibitors\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e11 (64.71%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eOpioid Analgesics\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e10 (58.82%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNSAIDs\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e9 (52.94%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAntidepressants\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e7 (41.18%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAntibiotics\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e5 (29.41%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAnxiolytics\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e5 (29.41%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePsychotropic Medications\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e3 (17.65%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eVitamin B Supplements\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e3 (17.65%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eVitamin D Supplements\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e2 (11.76%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAntidiabetic Medications\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e2 (11.76%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"8\" rowspan=\"9\"\u003e \u003cp\u003e\u003cb\u003eDocumented Comorbidities\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eHypertension\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e13 (76.47%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eChronic Pain\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e9 (52.94%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eObesity\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e5 (29.41%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eDepression\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e5 (29.41%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAnxiety\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e4 (23.53%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eDiabetes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e4 (23.53%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eWeight Loss\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e2 (11.76%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eDecreased Mobility\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e2 (11.76%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eHearing Loss\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e1 (5.88%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eFifteen (38.46%) out of the 17 patients were exposed to ICI therapy for at least 30 days, with 35.29% receiving ICI therapy for over 180 days. While 76.47% of patients experienced IMDC symptoms within 90 days of their last ICI infusion, four patients had delayed-onset IMDC, occurring up to 370 days after their final ICI exposure.\u003c/p\u003e \u003cp\u003eIn terms of IMDC symptom reporting, 13 out of 17 patients reported IMDC symptoms within 21 days of onset. However, four individuals had untreated low-grade diarrhea for extended periods, in some cases lasting as long as one year. The outpatient oncology clinic and emergency department (ED) were the primary settings for the initial evaluation of IMDC, with 64.71% (\u003cem\u003en\u003c/em\u003e\u0026thinsp;=\u0026thinsp;11) and 23.53% (\u003cem\u003en\u003c/em\u003e\u0026thinsp;=\u0026thinsp;4) of patients assessed in these settings, respectively. However, five of 13 patients with IMDC initially seen in an outpatient setting were later assessed at the ED. Only two patients contacted the outpatient oncology triage line to report their symptoms.\u003c/p\u003e \u003cp\u003eAll patients reported diarrhea as their chief complaint, with 88.24% presenting with moderate or severe IMDC per NCCN grading criteria. Other common symptoms included weight loss (41.18%) and nausea and/or vomiting (35.29%), while blood-tinged stools were reported by only 11.76% of patients. Additionally, 47.06% of patients had attempted an unsuccessful trial of the over-the-counter antidiarrheal agent Imodium (loperamide) before seeking medical care. Notably, 41.18% of patients developed other concurrent irAEs, with autoimmune dermatitis and hepatitis being the most prevalent. Table\u0026nbsp;\u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e3\u003c/span\u003e provides an overview of IMDC presenting symptoms and reporting patterns.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab4\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eClinical Presentation and Reporting Patterns among Patients with IMDC (n\u0026thinsp;=\u0026thinsp;17)\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"3\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eParameter\u003c/em\u003e\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cem\u003eCategories\u003c/em\u003e\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cem\u003ePatients\u003c/em\u003e (\u003cem\u003en\u003c/em\u003e\u0026thinsp;=\u0026thinsp;17)\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"3\" rowspan=\"4\"\u003e \u003cp\u003e\u003cb\u003eICI therapy exposure duration (days)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;30\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e2 (11.76%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e30\u0026ndash;90\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e6 (35.29%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e91\u0026ndash;180\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e3 (17.65%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u0026gt;\u0026thinsp;180\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e6 (35.29%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"3\" rowspan=\"4\"\u003e \u003cp\u003e\u003cb\u003eDays elapsed between last ICI dose and IMDC symptom onset\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;15\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e4 (23.53%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e15\u0026ndash;30\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e5 (29.41%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e31\u0026ndash;90\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e4 (23.53%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u0026gt;\u0026thinsp;90\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e4 (23.53%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"2\" rowspan=\"3\"\u003e \u003cp\u003e\u003cb\u003eDays elapsed between IMDC symptom onset and report\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e10 (58.82%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e7\u0026ndash;21\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e3 (17.65%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u0026gt;\u0026thinsp;21\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e4 (23.53%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"2\" rowspan=\"3\"\u003e \u003cp\u003e\u003cb\u003eSetting of Initial IMDC evaluation\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eOutpatient Clinic Visit\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e11 (64.71%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eED Evaluation\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e4 (23.53%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eOncology Triage\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e2 (11.76%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"6\" rowspan=\"7\"\u003e \u003cp\u003e\u003cb\u003eIMDC presenting symptoms\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eDiarrhea\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e17 (100.00%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eWeight Loss\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e7 (41.18%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNausea and/or Vomiting\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e6 (35.29%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAbdominal Pain\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e5 (29.41%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNocturnal Diarrhea\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e4 (23.53%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eStool Incontinence\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e3 (17.65%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eBlood in Stool\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e2 (11.76%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"2\" rowspan=\"3\"\u003e \u003cp\u003e\u003cb\u003eIMDC severity (based on number of bowel movements/day)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMild (\u0026lt;\u0026thinsp;4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e2 (11.76%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eModerate (4\u0026ndash;6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e8 (47.06%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eSevere (\u0026gt;\u0026thinsp;6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e7 (41.18%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e\u003cb\u003eTrial of Imodium\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e8 (47.06%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNo/Unknown\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e9 (52.94%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e\u003cb\u003eConcurrent irAEs\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e7 (41.18%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNo/Unknown\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e10 (58.82%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eOverall, 52.94% (\u003cem\u003en\u003c/em\u003e\u0026thinsp;=\u0026thinsp;9) of patients with IMDC were evaluated at the ED, four at initial onset and five for subsequent symptom management. Three out of four patients (75%) initially evaluated at the ED were started on the appropriate dose of systemic corticosteroids, with an average dose of 0.89 mg/kg/day, and two had diagnostic imaging and stool tests ordered. One patient, seen at a different ED location, had incomplete records on the extent of IMDC workup but was initiated on appropriate corticosteroid therapy. Additionally, two patients with severe symptoms initially seen in the oncology clinic were referred to the ED the same day, where they received diagnostic imaging, stool marker assessments, and immunosuppression consistent with NCCN recommendations. Only one ED-assessed patient did not receive adequate management, instead being given fluids, electrolytes, and Imodium despite severe symptoms.\u003c/p\u003e \u003cp\u003eIn contrast, of the 13 patients initially evaluated in the outpatient setting, only one had stool markers, and diagnostic imaging ordered the same day (excluding the two referred to the ED). However, three of these patients had undergone comprehensive imaging, including scans of the abdomen and pelvis, shortly before the onset of IMDC symptoms. Although 11 of 13 individuals (84.62%) evaluated in the oncology clinic reported moderate or severe symptoms, only four (30.78%) were started on systemic corticosteroids the same day, all at a dose below the 1 mg/kg/day recommended by the NCCN (mean\u0026thinsp;=\u0026thinsp;0.64 mg/kg/day). The remaining seven patients managed in an outpatient setting were initially advised to use Imodium, though all eventually required systemic corticosteroids, and one case necessitated infliximab. Additionally, three individuals assessed in the oncology outpatient clinics received a dose of ICI therapy despite reporting moderate IMDC symptoms. Table\u0026nbsp;\u003cspan refid=\"Tab5\" class=\"InternalRef\"\u003e4\u003c/span\u003e summarizes adherence to NCCN guideline\u0026ndash;recommended practices across ED and outpatient oncology settings.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab5\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 4\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eSummary of Adherence to NCCN Guidelines by Clinical Setting (Initial Presentation)\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"5\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cem\u003eSymptom Grading Documented\u003c/em\u003e\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cem\u003eInfectious Workup (C. difficile\u0026thinsp;\u0026plusmn;\u0026thinsp;stool markers)\u003c/em\u003e\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u003cem\u003eSteroid Dosing (\u0026ge;\u0026thinsp;1 mg/kg prednisone eq.)\u003c/em\u003e\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u003cem\u003eICI Hold/ Rechallenge (per guidelines)\u003c/em\u003e\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eEmergency Department (n\u0026thinsp;=\u0026thinsp;4)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e4 (100%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2 (50%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e3 (75%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e4 (100%) All ICIs appropriately held; 2 later rechallenged after resolution\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eOutpatient Oncology Clinic (n\u0026thinsp;=\u0026thinsp;13)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e11 (84.6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1 (7.7%) same day\u0026thinsp;+\u0026thinsp;3 (23%) had recent imaging\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e4 (30.8%) same-day start\u0026thinsp;\u0026lt;\u0026thinsp;1 mg/kg\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e10 (76.9%) ICI held appropriately; 3 received dose despite symptoms\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"5\"\u003e\u003cb\u003eNote\u003c/b\u003e. Adherence reflects initial presentation only. Two outpatients were later referred to the ED for guideline-concordant management and are not double-counted here. Data derived from institutional electronic health records (n\u0026thinsp;=\u0026thinsp;17).\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eAmong the eight patients tested for \u003cem\u003eC. difficile\u003c/em\u003e and other common pathogens, all had negative stool findings. In contrast, all patients who had inflammatory stool markers assessed had elevated calprotectin (5/5) and positive lactoferrin (4/4). Of the seven CT scans conducted as part of the IMDC evaluation or shortly before symptom onset, four revealed bowel wall thickening and edema. Only two patients (11.76%) underwent diagnostic colonoscopy, with one revealing lymphocytic colitis and the other showing no abnormal findings.\u003c/p\u003e \u003cp\u003eNearly half (47.06%) of patients were started on systemic corticosteroids the day they first reported IMDC symptoms. The remaining 52.94%, predominantly those with mild to moderate IMDC, were initially managed conservatively with Imodium and dietary modifications before progressing to steroid therapy. Oral prednisone was the initial therapy in 76.47% of cases, while the remaining 23.53% received intravenous or oral methylprednisolone. Bactrim was prescribed in 47.06% of cases for \u003cem\u003eP. jirovecii\u003c/em\u003e pneumonia prophylaxis, and 76.47% of patients were on concurrent proton pump inhibitor therapy, either initiated with steroids (11.76%) or continued from an existing prescription (64.71%). Imodium was recommended in 88.24% of cases as an adjunct for symptom management.\u003c/p\u003e \u003cp\u003eWhile only one patient required additional immunosuppression, first with infliximab and later with vedolizumab, 29.41% of patients experienced refractory diarrhea after initiating steroid taper, requiring a dose increase. Overall, 88.24% of patients remained on immunosuppressive therapy for at least 30 days, with only two patients undergoing rapid steroid taper. At the time of IMDC diagnosis, 58.82% had their ICI therapy suspended or permanently discontinued, while four patients continued ICI treatment either until symptom progression or, in mild cases, while on immunosuppressive therapy. Only four patients (23.53%) resumed ICI therapy upon IMDC resolution, all receiving the same ICI as before. One individual who developed IMDC following the completion of ICI therapy, continued with surveillance following IMDC resolution. Of the 12 patients (70.59%) who permanently discontinued ICI therapy, three (25%) transitioned to Hospice, two (16.67%) experienced disease progression and were switched to chemotherapy, one patient (8.33%) who was on a combination ICI plus targeted agent regimen continued the targeted agent without resuming the ICI, four individuals (33.33%) whose disease remained stable off treatment transitioned to surveillance. The remaining two patients were changed to alternative non-ICI therapies. Table\u0026nbsp;\u003cspan refid=\"Tab7\" class=\"InternalRef\"\u003e5\u003c/span\u003e provides an overview of IMDC diagnostic workup and clinical course.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab6\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 5\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eDiagnostic Workup, Therapeutic Management, and Clinical Course of IMDC (n\u0026thinsp;=\u0026thinsp;17)\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"3\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eParameter\u003c/em\u003e\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cem\u003eCategories\u003c/em\u003e\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cem\u003ePatients\u003c/em\u003e (\u003cem\u003en\u003c/em\u003e\u0026thinsp;=\u0026thinsp;17)\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e\u003cb\u003eC. difficile and stool pathogens\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAssessed\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e8 (47.06%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNot assessed\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e9 (52.94%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e\u003cb\u003eStool calprotectin\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAssessed\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e5 (29.41%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNot assessed\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e12 (70.59%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e\u003cb\u003eStool lactoferrin\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAssessed\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e4 (23.53%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNot assessed\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e13 (76.47%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e\u003cb\u003eAbdominal imaging\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eOrdered\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e7 (41.18%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNot ordered\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e10 (58.82%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e\u003cb\u003eGastroenterology consult\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eRequested\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e2 (11.76%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNot requested\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e15 (88.24%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e\u003cb\u003eRequired ED management\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e9 (52.94%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e8 (47.06%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"2\" rowspan=\"3\"\u003e \u003cp\u003e\u003cb\u003eDays elapsed between initial evaluation and steroid therapy initiation\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e8 (47.06%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1\u0026ndash;7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e6 (35.29%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u0026gt;\u0026thinsp;7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e3 (17.65%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"2\" rowspan=\"3\"\u003e \u003cp\u003e\u003cb\u003eInitial corticosteroid type and route\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePrednisone PO\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e13 (76.47%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMethylprednisolone IV\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e3 (17.65%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMethylprednisolone PO\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e1 (5.88%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"2\" rowspan=\"3\"\u003e \u003cp\u003e\u003cb\u003eInitial corticosteroid dose\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;1 mg/kg/day\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e7 (41.18%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 mg/kg/day\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e8 (47.06%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2 mg/kg/day\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e2 (11.76%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e\u003cb\u003eInfliximab or vedolizumab immunosuppression required?\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e1 (5.88%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e16 (94.12%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e\u003cb\u003eRefractory diarrhea following steroid taper?\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e5 (29.41%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e12 (70.59%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"3\" rowspan=\"4\"\u003e \u003cp\u003e\u003cb\u003eImmunosuppressive therapy duration (mean\u0026thinsp;=\u0026thinsp;92.29 days)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;30 days\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e2 (11.76%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e30\u0026ndash;60 days\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e7 (41.18%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e61\u0026ndash;90 days\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e6 (35.29%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u0026gt;\u0026thinsp;90 days\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e2 (11.76%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"2\" rowspan=\"3\"\u003e \u003cp\u003e\u003cb\u003eSupportive therapy\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eBactrim\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e8 (47.06%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eProton Pump Inhibitor\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e13 (76.47%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eImodium\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e15 (88.24%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"2\" rowspan=\"3\"\u003e \u003cp\u003e\u003cb\u003eWas ICI therapy interrupted at IMDC onset?\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e10 (58.82%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e4 (23.53%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNot applicable\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e3 (17.65%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e\u003cb\u003eWas ICI therapy resumed after IMDC resolution\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e10 (58.82%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e4 (23.53%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab7\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 5\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003econtinued\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"3\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eParameter\u003c/em\u003e\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cem\u003eCategories\u003c/em\u003e\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cem\u003ePatients\u003c/em\u003e (\u003cem\u003en\u003c/em\u003e\u0026thinsp;=\u0026thinsp;17)\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNot applicable\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e3 (17.65%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e\u003cb\u003eWas clinical rationale provided for discontinuing/resuming ICI therapy?\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e11 (64.71%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e6 (35.29%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e\u003cb\u003eWere NCCN guidelines referenced in clinical notes?\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0 (0.00%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e17 (100.00%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"3\"\u003e\u003csup\u003e*\u003c/sup\u003e\u003cb\u003eNote\u003c/b\u003e. \u0026ldquo;Not applicable\u0026rdquo; includes two patients whose ICI therapy was held later the same day after ED referral and one patient who developed IMDC following completion of ICI therapy.\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eResults Summary and Interpretation of Findings\u003c/p\u003e \u003cp\u003eWe observed significant variation in diagnostic workup and management of IMDC. Patients evaluated at the ED generally received care most consistent with NCCN clinical guidelines [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e], whereas seven out of 13 patients initially seen in the outpatient clinic were started on Imodium before progressing to systemic corticosteroids, and three received an additional dose of ICI therapy despite reporting moderate IMDC symptoms.\u003c/p\u003e \u003cp\u003eThe discrepancies between ED and outpatient management approaches may be explained by differences in resources available to clinicians in each setting. Additionally, ED clinicians may adhere more strictly to clinical algorithms, whereas clinicians in oncology outpatient clinics may have more flexibility in tailoring management strategies to individual patient needs and goals of care. Delayed IMDC management in outpatient clinics may also occur when IMDC symptoms are confused with chemotherapy-related toxicities in patients receiving concurrent ICI and chemotherapy, leading to missed guideline-recommended interventions and complicating timely oncology triage.\u003c/p\u003e \u003cp\u003eConsistent with prior studies [\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e, \u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e], fecal calprotectin and lactoferrin were reliable markers of IMDC, showing abnormalities in all affected individuals, while abdominal imaging and endoscopic evaluation findings were less consistent, with four out of seven CT scans and one out of two colonoscopies revealing abnormalities consistent with IMDC. Delayed onset IMDC, occurring\u0026thinsp;\u0026gt;\u0026thinsp;90 days after the last ICI exposure, was observed in 23.53% of patients, reinforcing the NCCN recommendation to follow patients previously treated with ICIs for at least two years [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eHypertension was present in over 76% (\u003cem\u003en\u003c/em\u003e\u0026thinsp;=\u0026thinsp;13) of individuals who experienced IMDC. Previous studies examining the relationship between common comorbidities and the incidence of immune-related adverse events (irAEs) have also identified hypertension as a potential risk factor [\u003cspan additionalcitationids=\"CR20\" citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e]. Additionally, 10 out of 17 patients had opioid analgesics and nine had non-steroidal anti-inflammatory drugs (NSAIDs) on their medication list. This finding aligns with studies reporting that opioid analgesics [\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e, \u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e] and NSAIDs [\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e] may have immunosuppressive effects, potentially increasing the risk of irAEs.\u003c/p\u003e \u003cp\u003eIn line with prior reports [\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e, \u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e], 76.47% of patients remained on immunosuppressive therapy for 30\u0026ndash;90 days, with a few outliers either requiring extended immunosuppression or responding to a rapid taper. Notably, 41.18% of patients with IMDC were diagnosed with co-occurring irAEs, predominately immune-mediated dermatitis. This finding closely aligns with previously published studies [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e, \u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e], highlighting the need for heightened vigilance in monitoring for additional irAEs in patients with IMDC and reinforcing the importance of comprehensive management strategies to address concurrent irAEs.\u003c/p\u003e \u003cp\u003eLastly, our findings revealed that only two out of 17 patients (11.76%) reported their IMDC symptoms directly to their oncology team. Moreover, 41.18% of patients experienced symptoms for more than seven days before seeking medical evaluation. This delay in symptom reporting underscores the need for improved patient education on common irAE presentations and the importance of timely symptom reporting to minimize the risk of complications.\u003c/p\u003e \u003cp\u003eStrengths and Limitations\u003c/p\u003e \u003cp\u003eBy focusing on the diagnostic workup and management of IMDC in a real-world clinical setting, this research adds valuable insights into the practical management of IMDC, which has not been extensively studied. The in-depth qualitative review of patient records allows for a nuanced understanding of symptom presentation, diagnostic workup, and clinical decision-making, enhancing our understanding of IMDC beyond what quantitative studies alone can reveal.\u003c/p\u003e \u003cp\u003eHowever, several limitations must also be acknowledged. First, the study was conducted at a single site, which may limit the generalizability of its findings. Second, the absence of a comparison group prevents assessment of whether specific demographic and clinical characteristics correlate with an increased risk of IMDC. Third, the relatively small patient cohort (\u003cem\u003en\u003c/em\u003e\u0026thinsp;=\u0026thinsp;17) limits the statistical power of the analysis and may introduce bias in capturing the full range of IMDC presentations and outcomes. The small sample size also reduces the ability to perform detailed subgroup analyses, which could have provided more granular insights into specific treatment approaches and patient outcomes.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003e Our findings revealed significant variation in the diagnostic workup and management of IMDC, with clinicians in the emergency department adhering more closely to clinical guidelines than those in outpatient settings. These insights underscore the need for a better understanding of real-world IMDC management and the factors contributing to deviations from established guidelines.\u003c/p\u003e \u003cp\u003eFuture research should focus on conducting large, multisite studies to gain a more comprehensive understanding of IMDC across diverse patient populations and clinical settings. A larger sample size would also enable more detailed subgroup analyses, potentially providing valuable insights into specific risk factors associated with IMDC.\u003c/p\u003e \u003cp\u003e Additionally, focused group interviews with oncology and acute care clinicians could help uncover the reasons for deviations from clinical guidelines and lay the foundation for expert panels to review, update, and disseminate best practices. Future work should also incorporate structured implementation strategies, such as standardized triage pathways, embedded stool test order panels, and EHR prompts for IMDC grading, to support prompt, guideline-concordant care. Automated patient messaging systems to flag early-onset diarrhea symptoms and IMDC checklists within oncology clinics may further streamline symptom identification and management, improving consistency across care settings.\u003c/p\u003e \u003cp\u003eCollectively, these workflow-integrated approaches can strengthen adherence to evidence-based IMDC management, support more timely and consistent diagnosis and treatment, and ultimately enhance the safety of immunotherapy delivery.\u003c/p\u003e \u003cp\u003eRelevance to Supportive Oncology\u003c/p\u003e \u003cp\u003eTimely recognition and evidence-based management of IMDC are essential to prevent avoidable symptom burden, emergency care utilization, and treatment interruptions. Identifying workflow gaps and opportunities for standardized triage and decision-support can strengthen supportive care processes for patients receiving immunotherapy.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cul\u003e\n \u003cli\u003eICI (Immune Checkpoint Inhibitor)\u003c/li\u003e\n \u003cli\u003eIMDC (Immune-Mediated Diarrhea and Colitis)\u003c/li\u003e\n \u003cli\u003eNCI (National Cancer Institute)\u003c/li\u003e\n \u003cli\u003eEHR (Electronic Health Record)\u003c/li\u003e\n \u003cli\u003eNCCN (National Comprehensive Cancer Network)\u003c/li\u003e\n \u003cli\u003eED (Emergency Department)\u003c/li\u003e\n \u003cli\u003eirAEs (Immune-Related Adverse Events)\u003c/li\u003e\n\u003c/ul\u003e"},{"header":"Declarations","content":"\u003ch2\u003eFunding\u003c/h2\u003e\n\u003cp\u003eNone.\u003c/p\u003e\n\u003ch2\u003eCompeting interests\u003c/h2\u003e\n\u003cp\u003eNone.\u003c/p\u003e\n\u003ch2\u003eEthics approval and consent to participate\u003c/h2\u003e\n\u003cp\u003eThis retrospective study was conducted in accordance with the ethical principles of the Declaration of Helsinki and all applicable regulatory requirements. The University of Utah Institutional Review Board approved the study protocol (IRB #00176995) and granted a waiver of informed consent under 45 CFR 46.116(f) and 45 CFR 164.512(i)(2)(ii).\u003c/p\u003e\n\u003ch2\u003eConsent for publication\u003c/h2\u003e\n\u003cp\u003eNot applicable.\u003c/p\u003e\n\u003ch2\u003eAvailability of data and materials\u003c/h2\u003e\n\u003cp\u003eDe-identified data available upon reasonable request.\u003c/p\u003e\n\u003ch2\u003eAuthor contributions\u003c/h2\u003e\n\u003cul\u003e\n \u003cli\u003eNatalya Alekhina: Conceptualization, Methodology, Data Preprocessing, Formal Analysis, Writing – Original Draft, Writing – Review and Editing\u003c/li\u003e\n \u003cli\u003eKathi Mooney: Conceptualization, Methodology, Writing – Review and Editing, Supervision\u003c/li\u003e\n \u003cli\u003eKatherine Sward: Conceptualization, Methodology, Data Preprocessing, Writing – Review and Editing\u003c/li\u003e\n \u003cli\u003eBob Wong: Methodology, Formal Analysis, Writing – Review and Editing\u003c/li\u003e\n \u003cli\u003eWallace Akerley: Methodology, Writing – Review and Editing.\u003c/li\u003e\n\u003c/ul\u003e\u003ch2\u003eData Availability\u003c/h2\u003e\u003cp\u003eDe-identified data available upon reasonable request.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eMartins F, Sofiya L, Sykiotis GP, et al. 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J Am Acad Dermatol. 2020;82(3):743\u0026ndash;746. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1016/j.jaad.2019.07.049\u003c/span\u003e\u003cspan address=\"10.1016/j.jaad.2019.07.049\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"supportive-care-in-cancer","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"jscc","sideBox":"Learn more about [Supportive Care in Cancer](https://www.springer.com/journal/520)","snPcode":"520","submissionUrl":"https://submission.nature.com/new-submission/520/3","title":"Supportive Care in Cancer","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false},"keywords":"Immune-related adverse events, Immune-Mediated Diarrhea and Colitis, Immune checkpoint inhibitors, Real-world evidence, Real-world practice, Clinical guideline adherence, Oncology practice, Immunotherapy toxicity.","lastPublishedDoi":"10.21203/rs.3.rs-8264047/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-8264047/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003ePurpose\u003c/h2\u003e \u003cp\u003eImmune-mediated diarrhea and colitis (IMDC) is a high-risk toxicity frequently experienced by patients treated with immune checkpoint inhibitors (ICIs) and requiring rapid supportive care interventions. Delays in IMDC reporting and inconsistent guideline adherence increase symptom burden and emergency department (ED) utilization. Although current practice guidelines provide IMDC management recommendations, adherence in routine oncology care remains uncertain. This study evaluated IMDC management and guideline concordance at a single National Cancer Institute\u0026ndash;designated comprehensive cancer center to identify workflow opportunities to improve supportive management.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eWe conducted a retrospective observational study of adults treated with ICIs between 2011 and 2024 who developed IMDC. Electronic health record (EHR) data were used to characterize patient demographics, IMDC reporting patterns, and to assess National Comprehensive Cancer Network (NCCN) guideline concordance in terms of IMDC diagnostic workup and management across care settings.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003e ED clinicians demonstrated greater adherence to NCCN guidelines than outpatient oncology providers. Of the 17 patients with IMDC, nine (52.94%) required ED management, with an average immunosuppressive therapy duration of 92.29 days, and only four (23.53%) resumed ICI therapy following IMDC resolution. Despite 88.24% of patients presenting with moderate-severe IMDC, 41.18% experienced symptoms for over a week before seeking medical care. Over 40% of patients with IMDC experienced concurrent immune-related adverse events (irAEs), with dermatitis and hepatitis being the most common.\u003c/p\u003e\u003ch2\u003eConclusion\u003c/h2\u003e \u003cp\u003eOur findings reveal actionable targets for improving IMDC supportive management. Implementing standardized workflows and decision-support tools may strengthen evidence-based IMDC care, reduce treatment delays, and improve patient outcomes.\u003c/p\u003e","manuscriptTitle":"Real-World Management and Outcomes of Immune-Mediated Diarrhea and Colitis: Gaps in Guideline Adherence and Opportunities for Implementation","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2026-01-19 17:11:55","doi":"10.21203/rs.3.rs-8264047/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2026-02-20T12:18:24+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2026-02-16T16:28:08+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"339680906670131790016272512246430887868","date":"2026-01-29T14:43:13+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2026-01-22T02:22:54+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"218855287118860035077957925878298964787","date":"2026-01-20T05:04:27+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2026-01-14T17:26:45+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-12-27T18:34:48+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2025-12-15T01:52:15+00:00","index":"","fulltext":""},{"type":"submitted","content":"Supportive Care in Cancer","date":"2025-12-02T20:35:17+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"supportive-care-in-cancer","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"jscc","sideBox":"Learn more about [Supportive Care in Cancer](https://www.springer.com/journal/520)","snPcode":"520","submissionUrl":"https://submission.nature.com/new-submission/520/3","title":"Supportive Care in Cancer","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false}}],"origin":"","ownerIdentity":"74fc6841-8ca6-4d7b-a93b-1dcc7767a8ff","owner":[],"postedDate":"January 19th, 2026","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2026-03-30T16:21:06+00:00","versionOfRecord":{"articleIdentity":"rs-8264047","link":"https://doi.org/10.1007/s00520-026-10562-9","journal":{"identity":"supportive-care-in-cancer","isVorOnly":false,"title":"Supportive Care in Cancer"},"publishedOn":"2026-03-28 16:10:35","publishedOnDateReadable":"March 28th, 2026"},"versionCreatedAt":"2026-01-19 17:11:55","video":"","vorDoi":"10.1007/s00520-026-10562-9","vorDoiUrl":"https://doi.org/10.1007/s00520-026-10562-9","workflowStages":[]},"version":"v1","identity":"rs-8264047","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-8264047","identity":"rs-8264047","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}