Abstract
BACKGROUND: To evaluate the role of the novel quantitative imaging biomarker (QIB) SUV(X%) of (18)F-FDG uptake extracted from early (18)F-FDG-PET/CT scan at 4 weeks for the detection of immune-related adverse events (rAE) in a cohort of patients with metastatic melanoma (mM) patients receiving immune-checkpoint inhibitors (ICI). PATIENTS AND METHODS: In this prospective non-interventional, one-centre clinical study, patients with mM, receiving ICI treatment, were regularly followed by (18)F-FDG PET/CT. Patients were scanned at baseline, early point at week four (W4), week sixteen (W16) and week thirty-two (W32) after ICI initiation. A convolutional neural network (CNN) was used to segment three organs: lung, bowel, thyroid. QIB of irAE - SUV(X%) - was analyzed within the target organs and correlated with the clinical irAE status. Area under the receiver-operating characteristic curve (AUROC) was used to quantify irAE detection performance. RESULTS: A total of 242 (18)F-FDG PET/CT images of 71 mM patients were prospectively collected and analysed. The early W4 scan showed improved detection only for the thyroid gland compared to W32 scan (p=0.047). The AUROC for detection of irAE in the three target organs was highest when SUV(X%) was extracted from W16 scan and was 0.76 for lung, 0.53 for bowel and 0.81 for thyroid. SUV(X%) extracted from W4 scan did not improve detection of irAE compared to W16 scan (lung: p = 0.54, bowel: p = 0.75, thyroid: p = 0.3, DeLong test), as well as compared to W32 scan in lungs (p = 0.32) and bowel (p = 0.3). CONCLUSIONS: Early time point (18)F-FDG PET/CT at W4 did not lead to statistically significant earlier detection of irAE. However, organ (18)F-FDG uptake as quantified by SUV(X%) proved to be a consistent QIB of irAE. To better assess the role of (18)F-FDG PET/CT in irAE detection, the time evolution of (18)F-FDG PET/CT quantifiable inflammation would be of essence, only achievable in multi centric studies.