PT - JOURNAL ARTICLE AU - Zou, Fangwen AU - Faleck, David AU - Thomas, Anusha AU - Harris, Jessica AU - Satish, Deepika AU - Wang, Xuemei AU - Charabaty, Aline AU - Ernstoff, Marc S AU - Glitza Oliva, Isabella C AU - Hanauer, Stephen AU - McQuade, Jennifer AU - Obeid, Michel AU - Shah, Amishi AU - Richards, David M AU - Sharon, Elad AU - Wolchok, Jedd AU - Thompson, John AU - Wang, Yinghong TI - Efficacy and safety of vedolizumab and infliximab treatment for immune-mediated diarrhea and colitis in patients with cancer: a two-center observational study AID - 10.1136/jitc-2021-003277 DP - 2021 Nov 01 TA - Journal for ImmunoTherapy of Cancer PG - e003277 VI - 9 IP - 11 4099 - http://jitc.bmj.com/content/9/11/e003277.short 4100 - http://jitc.bmj.com/content/9/11/e003277.full SO - J Immunother Cancer2021 Nov 01; 9 AB - Background Current treatment guidelines for immune-mediated diarrhea and colitis (IMDC) recommend steroids as first-line therapy, followed by selective immunosuppressive therapy (SIT) (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 two-center, 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.Results A total of 184 patients (62 vedolizumab, 94 infliximab, 28 combined sequentially) were included. The efficacy of achieving clinical remission of IMDC was similar (89% vs 88%, p=0.79) between the two groups. Compared with the infliximab group, the vedolizumab group had a shorter steroid exposure (35 vs 50 days, p<0.001), fewer 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 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, ≥3 doses of SIT (p=0.011), and fewer steroid tapering attempts (p=0.012) were associated with favorable overall survival.Conclusions Treatment with vedolizumab as compared with infliximab for IMDC led to comparable IMDC response rates, shorter duration of steroid use, fewer hospitalizations, and lower IMDC recurrence, though with slightly longer time to IMDC response. Higher number of SIT doses was associated with better survival outcome, while more steroid exposure resulted in worse patient outcomes.Data are available on reasonable request.