Efficacy and safety of vedolizumab and infliximab treatment for immune-mediated diarrhea and colitis in patients with cancer: A two-center observational study Journal Article
| Authors: | Zou, F.; Faleck, D.; Thomas, A.; Harris, J.; Satish, D.; Wang, X.; Charabaty, A.; Ernstoff, M. S.; Glitza Oliva, I. C.; Hanauer, S.; McQuade, J.; Obeid, M.; Shah, A.; Richards, D. M.; Sharon, E.; Wolchok, J.; Thompson, J.; Wang, Y. |
| Article Title: | Efficacy and safety of vedolizumab and infliximab treatment for immune-mediated diarrhea and colitis in patients with cancer: A two-center observational study |
| Abstract: | 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. © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ. |
| Keywords: | adult; controlled study; aged; major clinical study; overall survival; cancer growth; drug efficacy; drug safety; cancer patient; melanoma; inflammation; cohort analysis; steroid; cytotoxicity; retrospective study; risk factor; histology; length of stay; hospitalization; immunotherapy; remission; recurrent disease; colitis; observational study; cytotoxic t lymphocyte antigen 4; immunosuppressive treatment; autoimmune disease; endoscopy; ulcer; programmed death 1 ligand 1; comparative effectiveness; microscopic colitis; infliximab; immune checkpoint inhibitor; human; male; female; article; immunologic; vedolizumab; treatment response time; acute active colitis; chronic active colitis; immune mediated colitis; immune mediated diarrhea; mucosal ulcer; non ulcerative inflammation |
| Journal Title: | Journal for ImmunoTherapy of Cancer |
| Volume: | 9 |
| Issue: | 11 |
| ISSN: | 2051-1426 |
| Publisher: | Biomed Central Ltd |
| Date Published: | 2021-11-01 |
| Start Page: | e003277 |
| Language: | English |
| DOI: | 10.1136/jitc-2021-003277 |
| PROVIDER: | scopus |
| PMCID: | PMC8601082 |
| PUBMED: | 34789551 |
| DOI/URL: | |
| Notes: | Article -- Export Date: 3 January 2022 -- Source: Scopus |
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