Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2024 Jun 28:74:102470.
doi: 10.1016/j.eclinm.2024.102470. eCollection 2024 Aug.

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

Antoine Adenis  1   2 , Arlette Da Silva  3 , Meher Ben Abdelghani  4 , Vincent Bourgeois  5 , Emilie Bogart  6 , Anthony Turpin  7   8 , Adrien Evin  9   10 , Aurelien Proux  11   12 , Marie-Pierre Galais  13 , Claire Jaraudias  14 , Julia Quintin  15 , Guillaume Bouquet  16 , Emmanuelle Samalin  1 , Nathalie Bremaud  17 , Sahir Javed  18 , Aline Henry  19 , Jean-Emmanuel Kurtz  20 , Delphine Cornuault-Foubert  21 , Helene Vandamme  22 , Elisabeth Lucchi  23 , Diane Pannier  24 , Christine Belletier  4 , Murielle Paul  25 , Licia Touzet  26 , Nicolas Penel  24   27 , Gisele Chvetzoff  28   29 , Marie-Cécile Le Deley  6   30
Affiliations

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

Antoine Adenis et al. EClinicalMedicine. .

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.

Keywords: Advanced cancer; Early palliative care; Patient-centered care; Randomised trial; Survival; Upper gastrointestinal cancer.

PubMed Disclaimer

Conflict of interest statement

Antoine Adenis: Grants or contracts from ARCUS, AstraZeneca, Bayer Pharma, BEIGENE, BMS, Roche; Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from BMS and Novartis. Support for attending meetings and/or travel from AstraZeneca, Bayer Pharma, BMS, MSD, Pierre Fabre, Servier. Participation on a Data Safety Monitoring Board or Advisory Board from Astellas, Bayer Pharma, BMS, MSD. Meher Ben Abdelghani: Support for attending meetings and/or travel from Servier, Merck, Amgen, Roche. Participation on a Data Safety Monitoring Board or Advisory Board from Incyte, Deciphera, Bayer, Pierre Fabre, Servier, BMS. Vincent Bourgeois: Grants or contracts from Servier. Support for attending meetings and/or travel from Ipsen, Astra Zeneca, Sanofi. Participation on a Data Safety Monitoring Board or Advisory Board from AstraZeneca, Pierre Fabre, Servier. Anthony Turpin: Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Servier, BMS, MSD, Viatris, AstraZeneca, Daiichi. Marie-Pierre Galais: Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Servier, BMS. Support for attending meetings and/or travel from Servier, Bayer, AAA, Merck. Emmanuelle Samalin: Grants or contracts from Merck, Bayer, Servier. Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Pierre Fabre Oncology; MSD, Amgen, BMS. Support for attending meetings and/or travel from Pierre Fabre Oncology; Servier, MSD. Participation on a Data Safety Monitoring Board or Advisory Board from Astellas, Servier, MSD. Sahir Javed: Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from AstraZeneca. Support for attending meetings and/or travel from Lilly, Pfizer. Delphine Cornuault-Foubert: Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from BMS. Support for attending meetings and/or travel from Vifor, Amgen, Leopharma, Mundipharma. Christine Belletier: Support for attending meetings and/or travel from Mundipharma, Servier and Viatris. Nicolas Penel: Grants or contracts from Bayer.

Figures

Fig. 1
Fig. 1
Flowchart.
Fig. 2
Fig. 2
Description of content of EPC visits.
Fig. 3
Fig. 3
Kaplan–Meier survival curves for overall survival.
Fig. 4
Fig. 4
Heterogeneity of treatment according to stratification factors, sex, age and timing of inclusion (intention-to-treat analysis).
Fig. 5
Fig. 5
Quality-of-life analysis (QLQ-C30). A. Box plot of differences in QLQ-C30 scores between baseline and week 24 for the 15 dimensions of the QLQ-C30 questionnaire. B. Relative treatment effect on the time until definitive deterioration of quality of life for the 15 dimensions of the QLQ-C30 questionnaire (details in Supplementary Table S2).
See this image and copyright information in PMC

References

    1. WHO Definition of palliative care. https://www.who.int/news-room/fact-sheets/detail/palliative-care/en/
    1. Ferrell B.R., Temel J.S., Temin S., et al. Integration of palliative care into standard oncology care: American Society of Clinical Oncology clinical practice guideline update. J Clin Oncol. 2017;35:96–112. - PubMed
    1. Jordan K., Aapro M., Kaasa S., et al. European Society for Medical Oncology (ESMO) position paper on supportive and palliative care. Ann Oncol. 2018;29:36–43. - PubMed
    1. Temel J.S., Greer J.A., Muzikansky A., et al. Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med. 2010;363:733–742. - PubMed
    1. Ferrell B.R., Twaddle M.L., Melnick A., Meier D.E. National consensus project clinical practice guidelines for quality palliative care guidelines, 4th edition. J Palliat Med. 2018;21:1684–1689. - PubMed

Associated data

LinkOut - more resources