Early palliative care and overall survival in patients with metastatic upper gastrointestinal cancers (EPIC): a multicentre, open-label, randomised controlled phase 3 trial

Background Early palliative care (EPC) leads to an improvement in quality of life and an unexpected survival benefit fi t compared with oncological care for patients with metastatic lung cancer. The Early Palliative Integrated Care (EPIC) is aimed at examining whether EPC can improve overall survival in patients with metastatic upper gastrointestinal cancer. Methods We performed a multicentre, open-label, randomised phase-3 trial. Eligible patients were >= 18 years, had metastatic upper gastrointestinal cancer and a performance status of 0-2. - 2. Patients from 19 French centres were randomly assigned between 10/10/2016 and 17/12/2021 to receive EPC plus oncological care or standard oncological care (SOC) alone. EPC was provided by palliative care physicians and included fi ve EPC visits scheduled every month, starting within 3 weeks after randomisation. The primary endpoint was overall survival, analysed by intention-to-treat. This study was registered at ClinicalTrials.gov (NCT02853474). Findings 470 patients were randomised: 233 and 237 patients in the EPC and SOC groups, respectively. In the EPC group, 216/233 patients (92.7%) underwent >= 1EPC visit, with 159 EPC visits per protocol (68.2%). The median follow-up duration was 46 months. We did not observe any overall survival difference between the EPC (median = 7.0 months [95% confidence fi dence interval, 6.1-8.8]) - 8.8]) and SOC groups (8.6 months [6.8-9.8]) - 9.8]) (stratified fi ed hazard ratio = 1.04 [0.86-1.26], - 1.26], p = 0.68). No significant fi cant heterogeneity was found in primary tumour locations, performance status groups, sex, age groups, and inclusion periods. Interpretation Our fi ndings suggested that receiving EPC did not improve the benefit fi t of oncological care with regard to overall survival in patients with metastatic upper gastrointestinal cancer.