Early palliative care and overall survival in patients with metastatic upper gastrointestinal cancers (EPIC): a multicentre, open-label, randomised controlled phase 3 trial
Year: 2024
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
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. Funding: Programme Hospitalier de Recherche Clinique, Ligue Contre le Cancer, Conseil Régional du Nord-Pas-de-Calais.
Source: EClinicalMedicine
Authors: Antoine Adenis, Arlette Da Silva, Meher Ben Abdelghani, Vincent Bourgeois, Emilie Bogart, Anthony Turpin, Adrien Evin, Aurelien Proux, Marie-Pierre Galais, Claire Jaraudias, Julia Quintin, Guillaume Bouquet, Emmanuelle Samalin, Nathalie Bremaud, Sahir Javed, Aline Henry, Jean-Emmanuel Kurtz, Delphine Cornuault-Foubert, Helene Vandamme, Elisabeth Lucchi, Diane Pannier, Christine Belletier, Murielle Paul, Licia Touzet, Nicolas Penel, Gisele Chvetzoff, Marie-Cécile Le Deley
Institutions: Inserm, Institut de Recherche en Cancérologie de Montpellier, Institut Regional du Cancer de Montpellier, Centre Oscar Lambret, Institut de Cancérologie Strasbourg, Centre Hospitalier de Boulogne sur Mer, Centre National de la Recherche Scientifique, Université de Lille, Institut Pasteur de Lille, Centre Hospitalier Universitaire de Lille, Centre de Recherches en Cancérologie de Lille, Université de Tours, Centre Hospitalier Universitaire de Nantes, methodS in Patient-centered outcomes and HEalth ResEarch, Nantes Université, Aix-Marseille Université, Institut Paoli-Calmettes, Economic & Social Sciences, Health Systems & Medical Informatics, Institut de Recherche pour le Développement, Centre François Baclesse, Centre Antoine Lacassagne, Institut de Cancérologie de l'Ouest, Centre Hospitalier de Tourcoing, Centre Georges François Leclerc, Centre Hospitalier de Valenciennes, Institut de Cancérologie de Lorraine, Centre Hospitalier de Béthune, Institut Curie, Evaluation des technologies de santé et des pratiques médicales, Lyon 1 Université, Centre Léon Bérard, Research on healthcare performance, Université Paris-Saclay, Centre de recherche en Epidémiologie et Santé des Populations
Language: English
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $5,000
OpenAlex ID: W4400106316