Surveillance With Fluorine-18 Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography of Patients With Stage I-to-III Lung Cancer After Completion of Curative treatment (SUPE_R): A Randomized Controlled Trial.

INTRODUCTION: Post-treatment surveillance is recommended for NSCLC owing to a high risk of recurrence, but evidence on the optimal surveillance method is lacking. This trial evaluates fluorine-18 fluorodeoxyglucose positron emission tomography/computed tomography ([18F]FDG PET/CT) versus contrast-enhanced CT (ceCT) for surveillance in patients with NSCLC. METHODS: In this multicenter, randomized controlled trial (SUPE_R, ClinicalTrials.gov NCT03740126), patients with stage IA-to-IIIC NSCLC were randomized one-to-one to standard surveillance (ceCT) or surveillance with [18F]FDG PET/CT after completion of curative treatment. The primary outcome was the proportion of recurrences treated with curative intent. Secondary outcomes included time to recurrence (TTR) and overall survival (OS). RESULTS: Between February 2019 and February 2022, 750 patients were randomized to PET/CT (n = 373) or CT (n = 377). Recurrences occurred in 164 patients (22%). The proportion of recurrences treated with curative intent was identical in the PET group (42/87) and CT group (37/77), both 48% (p = 0.98). More recurrences were detected through scheduled follow-up in the PET group (90%) than in the CT group (77%; p = 0.02). There were no significant differences in TTR (hazard ratio 1.12, 95% confidence interval 0.82-1.52, p = 0.48) or OS (hazard ratio 0.97, 95% confidence interval 0.66-1.43, p = 0.89) between groups. CONCLUSIONS: Surveillance with [18F]FDG PET/CT did not improve rates of curatively treated recurrences, TTR, or OS compared with ceCT in patients with NSCLC after curative treatment. These findings do not support the routine use of [18F]FDG PET/CT for post-treatment surveillance in this patient population.