Prescreening of immune-related adverse events in our institute

Abstract

Background: In Japanese guideline of immune-related adverse events (irAEs), prescreening tests are recommended. We investigated implementation status of prescreening in patients treated with immune checkpoint inhibitor (ICI). Methods: Patients treated with nivolumab, pembrolizumab or ipilimumab in our institute were analyzed retrospectively. According to prescreening valuable, we listed 12 items as followed: chest X-ray and/or computed tomography (CT), KL-6, thyrotropin (TSH), free triiodothyronine (T3), free thyroxine (T4), aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transpeptidase (gamma-GTP), alkaline phosphatase (ALP), bilirubin, creatin kinase (CK) and blood glucose. Each item was scored as one point and implementation rate of prescreening was calculated. Results: Between September 2014 and June 2018, total of 77 patients treated with ICI agent were analyzed as followed: median age 67 years (range 22-84), female/male 32/45, nivolumab/pembrolizumab/ipilimumab 60/14/3, non-small-cell lung cancer/renal cell cancer/malignant melanoma/head and neck cancer/gastric cancer/urothelial carcinoma/Hodgkin lymphoma 41/13/9/7/4/2/1, thyroid dysfunction/liver dysfunction/pneumonitis/myositis or myasthenia gravis/colitis/infusion reaction 13 (17%)/7 (9.0%)/6 (7.8%)/3 (3.9%)/2 (2.6%)/2 (2.6%). Sixty-three patients (81.8%) were screened with more than 10 prescreening points, but 14 patients (18.2%) with 6-8 points. There was no significant difference between score of prescreening and irAE incidence. Although Xray/ CT, AST, ALT, gamma-GTP, ALP and bilirubin were checked in all cases, each detection rate of KL-6, thyroid function test, CK or blood glucose was under 80%. Conclusions: We reported prescreening of irAE real-world data in a Japanese standard hospital. Further studies are needed to build a better scoring system using a highly sensitive prescreening for early detection of irAEs.