Abstract
Background: Early palliative care (EPC) leads to an improvement in quality of life and an unexpected survival benefit 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. 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 five 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 interval, 6.1-8.8]) and SOC groups (8.6 months [6.8-9.8]) (stratified hazard ratio = 1.04 [0.86-1.26], p = 0.68). No significant heterogeneity was found in primary tumour locations, performance status groups, sex, age groups, and inclusion periods.Interpretation: Our findings suggested that receiving EPC did not improve the benefit of oncological care with regard to overall survival in patients with metastatic upper gastrointestinal cancer.