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Δευτέρα 6 Νοεμβρίου 2017

Inflammatory gastrointestinal diseases associated with PD-1 blockade antibodies

Abstract
Background
Immune check-point blockade agents have shown clinical activity in cancer patients but are associated with immune-related adverse events that could limit their development. The aim of this study was to describe the gastrointestinal immune-related adverse events (GI-irAE) in patients with cancer treated with anti-PD-1.
Methods
this is a retrospective study of consecutive adult patients who had a suspected GI-irAE due to anti-PD-1 antibodies between 2013 and 2016. Patients were recruited through a pharmacovigilance registry. Patients' data were reviewed by a multidisciplinary committee that included gastroenterologists, oncologists and a pathologist. Quantitative variables are described by median (range), qualitative variable by frequency (percentage).
Results
Forty-four patients were addressed to a Gastroenterology unit for a suspected GI-IrAE. Twenty patients had a confirmed GI-irAE related to anti-PD-1, which occurred 4.2 months (0.2; 22.1) after the initiation of anti-PD-1. GI-IrAE incidence rate under anti-PD-1 treatment was estimated to be 1.5%. Among patients with GI-IrAE, main symptoms were diarrhoea (n =16, 80%), abdominal pain (n =13, 65%), nausea and vomiting (n =11, 55%), intestinal obstruction (n =1, 5%), and haematochezia (n =2, 10%). No patient had colectomy. Four distinct categories of GI-irAE were observed: acute colitis (n =8, 40%), microscopic colitis (n =7, 35%), upper gastrointestinal tract inflammation (n =4, 20%) and pseudo-obstruction (n =1, 5%). Response rates to corticosteroids were 87.5% (7/8) in acute colitis, 57% (4/7) in microscopic colitis and 75% (3/4) in upper gastrointestinal tract inflammation. Median time to resolution was 36 days (6–172) in acute colitis, and 98 days (42–226) in microscopic colitis.
Conclusion
This study suggests that GI-irAE are different and less frequent with anti PD-1 than with anti CTLA-4.

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