Efficacy and Safety of Vedolizumab and Infliximab Treatment for Immune-Mediated Diarrhea and Colitis in Cancer Patients: A Multi-Center Study

Abstract

Background: Current treatment guidelines for IMDC recommend steroids as first-line therapy, followed by SITs (infliximab or vedolizumab) for refractory cases. We aimed to compare the efficacy of these two SITs and their impact on cancer outcomes. Methods: We performed a multicenter, retrospective observational cohort study of patients with IMDC who received SITs following steroids from 2016 to 2020. Patients’ demographic, clinical, and overall survival data were collected and analyzed. Findings: A total of 184 patients (62 vedolizumab, 94 infliximab, 28 both) were included. The efficacy of achieving clinical remission of IMDC was similar (89% vs 88%, P =0.79) between the two groups. Compared with infliximab group, vedolizumab group had a shorter steroid exposure (35 vs. 50 days, P <0·001), less hospitalizations (16% vs. 28%, P =0·005), and a shorter hospital stay (median 10·5 vs. 13·5 days, P =0·043), but a longer time to clinical response (17.5 vs. 13 days, P =0·012). Longer durations of immune checkpoint inhibitors (ICIs) treatment (OR 1·01, P =0·004) and steroid use (OR 1·02, P =0·043), and infliximab use alone (OR 2·51, P =0·039) were associated with higher IMDC recurrence. Furthermore, vedolizumab alone ( P =0·027), ≥3 doses of SIT ( P =0·011), and fewer steroid tapering attempts ( P =0·012) were associated with favorable overall survival. Interpretation: Treatment with vedolizumab as compared to infliximab for IMDC led to comparable IMDC response rates, shorter duration of steroid use and fewer hospitalizations, though with slightly longer time to IMDC response. Vedolizumab treatment also associated with lower rates of cancer progression and better overall survival. Funding: None to declare Declaration of Interest: None to declare Ethical Approval: The ethics approval of this study was granted by the IRB committee at the University of Texas MD Anderson Cancer Center and Memorial Sloan Kettering Cancer Center. The consent was waived for this study. The datasets used and analyzed during the current study are available from the corresponding author on reasonable request.