ABSTRACT
Introduction: Even after completion of curative treatment for non-small cell lung cancer (NSCLC), patients have a high risk of recurrence and consequently, active surveillance is recommended. The SUPE_R trial is an ongoing trial, designed to explore whether surveillance with F-18 fluoro-deoxy-glucose positron emission tomography/computed tomography (FDG PET/CT) and cell-free tumor DNA sequencing (ctDNA) can improve recurrence detection and increase the number of treatable relapses. Methods: Patients diagnosed with NSCLC who are candidates for curative therapy, are recruited prior to therapy to obtain a baseline blood sample for ctDNA analysis (part 1). After successful completion of curative treatment verified at the first post-treatment surveillance CT scan, patients are randomized to either continue standard surveillance or surveillance with FDG PET/CT replacing CT every 6 months, for two years or until recurrence (part 2). Baseline characteristics were recorded for all patients, as well as reasons for dropout or exclusion of patients not randomized for part 2. [Formula presented] Results: Patient enrollment started in 2018 and the inclusion goal of 750 randomized patients was met in November 2021. As of February 2022, 40.4% (n = 303) of randomized patients have completed the intervention. 923 patients were enrolled in part 1 (table 1). 492 (53.3%) patients included in part 1 were not randomized for part 2. This was most frequently due to dropout before screening for part 2 (n = 203, 41.3%), refusal to participate in part 2 (n = 118, 12.8%), exclusion due to unmet inclusion criteria for part 2 (n = 97, 10.5%) or progressive disease (n = 62, 6.7%). Twenty-two patients missed screening for part 2 due to Covid-19. 319 patients were included in part 2 without prior inclusion in part 1. The proportion of patients not randomized for part 2 was higher for patients with advanced disease at diagnosis (stage III) compared to patients with localized disease (stage I-II, 64.7 vs 47.8%, p < 0.001), which is partially explained by a higher risk of death (6.3 vs 2.2%, p = 0.008) and disease progression (9.5 vs 5.5%, p = 0.063) in these patients. Conclusions: Enrollment in the SUPE_R trial was recently completed after 3 years of patient recruitment. Half of patients included in part 1 were not randomized for part 2 and the proportion of patients not randomized was higher for patients with more advanced disease at diagnosis. Whether this will affect the outcome of the SUPE_R trial remains to be explored. Keywords: Surveillance, PET/CT, ctDNA