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
ABSTRACT
INTRODUCTION: We explored transmission of the coronavirus disease 2019 (COVID-19) in severely ill patients and analysed the relationship between co-morbidity and mortality or the need for intensive care unit (ICU) care. METHODS: Clinical data, treatment and outcome were analysed in this retrospective study of 101 consecutive patients with COVID-19 admitted to a regional Danish hospital from 2 March 2020, based on data from electronic medical records. RESULTS: The mean age was 71.8 years, 33% were never smokers and 82% had one or more predefined chronic diseases. In-hospital mortality was 30%, and 20% of the patients were offered ICU care. In ICU patients, we found a male preponderance (88% versus 44%, p = 0.006), but death (50% versus 25%, p = 0.053) and other pre-defined co-morbidities did not differ significantly from non-ICU patients. The source of infection was unknown in 74% of patients, related to endemic travel in 10%, hospital acquired in 6% and related to close acquaintances in 11%. COVID-19-related symptoms were initially observed from February 21 (week 8 and week 9) in the first three patients who had no known source of infection. We found that 7% of cases had an increased risk of in-hospital transmission, based on a 7-16 days delay in coronavirus testing. CONCLUSIONS: The frequency of co-morbidity in hospital-admitted COVID-19 patients and the correlation to death and ICU attendance were analysed. In all, 74% of the infection cases were of unknown source during the first weeks of the epidemic, which points to considerable community transmission and possibly pre-or asymptomatic transmission, also several weeks before 21 February 2020. FUNDING: none. TRIAL REGISTRATION: not relevant after correspondence with the Ethics Committee of Region Zealand. Furthermore, permission was granted from The Danish Data Protection Agency, Region Zealand (REG-070-2020).