Health-Related Quality of Life in patients with Checkpoint Inhibitor Enterocolitis

ABSTRACT

IntroductionImmune checkpoint inhibitors (CPI) have transformed the treatment of many advanced cancers but cause immune related adverse events including enterocolitis (CPI-E). The conventional inflammatory bowel diseases ulcerative colitis (UC) and Crohn’s disease (CD) are associated with unfavourable health-related quality of life (HRQoL) outcomes, but there are currently no data on HRQoL in the setting of CPI-E. This study aimed to investigate HRQoL in CPI-E.MethodsA prospective study was conducted across two London hospital trusts between February-April 2021. UC, CD and CPI-E patient cohorts were recruited from outpatient clinics and the biologic infusion unit. Disease activity was assessed using non-invasive scoring systems modified-Partial Mayo Score (m-PMS), modified-Harvey Bradshaw Index (m-HBI), Simple Crohn’s and Colitis Activity Index (SCCAI) and Common Terminology Criteria for Adverse Events (CTCAE). HRQoL outcomes were assessed using validated questionnaires Patient Health Questionnaire-8 (PHQ-8), Generalised Anxiety Disorder-7 (GAD-7), IBD-Questionnaire (IBD-Q) and Multidimensional Assessment of Fatigue (MAF).ResultsSeventy-five patients (33 CD, 21 UC, 21 CPI-E) were recruited. 33 CD patients (100%) and 20 UC patients (95.2%) were receiving biologic therapy. Thirteen CPI-E patients (61.9%) received Anti-PD1/PDL1 monotherapy and (38.1%) received combination anti-PD1 and anti-CTLA-4 therapy. Twenty-four CD patients (72.7%), 11 UC patients (52.4%) and 16 CPI-E patients (76.2%) were shielding due to the COVID-19 pandemic. Using m-PMS, m-HBI, SCCAI and CTCAE, >80% in each of the three cohorts were either classed as being in remission or having mild disease activity. Three CPI-E patients (14.3%) had moderate depression (PHQ-8 ≥10) and a further 9 (42.9%) had mild depression (PHQ-8 score 5-9). Nine CPI-E patients (42.9%) had significant fatigue (MAF score ≥30) and 6 (28.6%) had mild or moderate anxiety (GAD-7 ≥5). There were no significant differences in PHQ-8, GAD-7, IBD-Q and MAF between CPI-E, CD and UC patients, suggesting comparable levels of psychological morbidity in the three groups. Significant correlations were found between CPI-E disease activity and IBD-Q and GAD-7 scores.ConclusionOur study suggests that psychological morbidity in CPI-E is common and comparable to rates in CD and UC, even in the setting of clinical remission. Clinicians should be aware of this complication and take a holistic approach to this patient group.