ABSTRACT
Aims: For cancer patients with oligo metastatic disease (OMD), defined as five metastases or less, a more aggressive treatment approach has been suggested. In SOFT, an international multicenter phase II trial, patients with OMD and infra-diaphragmatic soft tissue metastases were treated with online MR-guided stereotactic ablative radiotherapy (SABR). To better identify early adverse events related to SABR, longitudinal collection of electronic patient-reported outcomes (ePROs) were included. As this is a short-course treatment in an elderly population our aim was to report the feasibility of continuous ePRO for the first 100 patients. Method(s): Patients were enrolled at four sites;Herlev Hospital, Rigshospitalet, Odense University Hospital in Denmark, and Henry Ford Hospital, Detroit. They were allocated to 3-8 radiotherapy fractions depending on target site and dose to organs at risk. Early toxicity was measured with eight symptomatic AEs from the PRO-CTCAE item library and quality of life with the EUROqol EQ-5D-5L at pre-specified time points (Fig. 1). A link to the ePRO system (REDCap) was sent out electronically. In case of no computer access, a paper version was provided. The invitation was re-send after 2 days. No back-up call was provided. Result(s): The first 100 patients having reached a 24-week follow-up evaluation were included in the analysis. Five patients had a second enrollment (105 enrollments) and 19 had more than one target. The median age was 70 years. The majority were men (67%) and had oligo metastatic recurrence (54%) (Table 1).The consent rate for ePRO completion was 87% (91 electronic/13 paper/1 declined). For an elderly population with metastatic cancer, the overall adherence level to PRO completion was high (88%) and the high level remained until week 24 (retention rate 91%) (Fig. 2). Only 44% of the paper questionnaires were completed week 24. This may partly be due to in-person visits being changed to telephone consults during COVID-19. Four patients (4%) reported technical difficulties. Conclusion(s): Collecting ePROs among elderly cancer patients with OMD having short-course radiotherapy is feasible. All but one patient completed PROs with the majority doing electronic reporting. Overall, adherence was high except for patients completing paper-based PROs.
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