Effect of Adapted Physical Activity in Patients With Advanced Pancreatic Cancer: The APACaP GERCOR Randomized Trial

Authors:
Cindy Neuzillet GERCOR, Paris, France
Department of Medical Oncology, Institut Curie – Site Saint Cloud, Versailles Saint-Quentin University, Paris Saclay University, Saint-Cloud, France

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Olivier Bouché Department of Digestive Oncology, Université de Reims Champagne-Ardenne, CHU Reims, Reims, France

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Christophe Tournigand Department of Medical Oncology, Assistance Publique–Hôpitaux de Paris, Hôpital Henri-Mondor, University Paris Est Créteil, Créteil, France

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Benoist Chibaudel Department of Medical Oncology, Hôpital Franco-Britannique – Fondation Cognacq-Jay, Levallois Perret, France

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Lucile Bauguion Department of Hepato-Gastroenterology, Hospital Center Departmental Vendée, La Roche-sur-Yon, France

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Leïla Bengrine-Lefevre Department of Medical Oncology, Georges-François Leclerc Cancer Center, UNICANCER, Dijon, France

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Daniel Lopez-Trabada Ataz Department of Medical Oncology, Saint-Antoine Hospital, Paris, France

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May Mabro Department of Medical Oncology, Foch Hospital, Suresnes, France

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Jean-Philippe Metges Cancerology and Hematology Institute, University Hospital, Brest, France

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Denis Péré-Vergé Department of Hepato-Gastroenterology, Centre Hospitalier Saint-Joseph Saint-Luc, Lyon, France

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Thierry Conroy Department of Medical Oncology, Institut de Cancérologie de Lorraine, Vandoeuvre-lès-Nancy, France
Université de Lorraine, APEMAC, équipe MICS, Nancy, France

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Astrid Lièvre Department of Gastroenterology, Rennes University Hospital, Rennes 1 University, Rennes, France

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Morgan Andre Department of Gastroenterology, Centre Hospitalier Intercommunal Mont-de-Marsan-Pays des Sources, Mont de Marsan, France

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Françoise Desseigne Department of Medical Oncology, Centre Léon Bérard, Lyon, France

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François Goldwasser Department of Medical Oncology, CARPEM, Cochin University Hospital, Assistance Publique–Hôpitaux de Paris, Paris Cité University, Paris, France

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Julie Henriques Unit of Methodology and Quality of Life in Oncology, Besançon University Hospital, Besançon, France
Bourgogne Franche-Comté University, INSERM, Etablissement Français du Sang Bourgogne Franche-Comté, UMR1098, Interactions Hôte-Greffon-Tumeur/Ingénierie Cellulaire et Génique, Besançon, France

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Amélie Anota Unit of Methodology and Quality of Life in Oncology, Besançon University Hospital, Besançon, France
Department of Clinical Research and Innovation & Human and Social Sciences Department, Centre Léon Bérard, Lyon, France

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Pascal Hammel GERCOR, Paris, France
Department of Medical and Digestive Oncology, Hôpital Beaujon, Assistance Publique–Hôpitaux de Paris, Clichy, France
Department of Digestive and Medical Oncology, Hôpital Paul Brousse, Assistance Publique–Hôpitaux de Paris, Paris Saclay University, Villejuif, France

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Volume/Issue:
Volume 21: Issue 12
Online Publication Date:
Dec 2023
DOI:
https://doi.org/10.6004/jnccn.2023.7065
Restricted access

Background: The impact of adapted physical activity (APA) on health-related quality of life (HRQoL) in patients with advanced pancreatic ductal adenocarcinoma (aPDAC) is unknown. This study evaluated whether APA in addition to standard care improved HRQoL in patients who have aPDAC who are receiving first-line chemotherapy. Patients and Methods: Patients with locally advanced/metastatic PDAC and an ECOG performance status of 0 to 2 were randomized (1:1) to receive standard care (standard arm) or standard care plus a home-based 16-week APA program (APA arm). The primary objective was the effect of the APA program on 3 dimensions of the EORTC QLQ-C30: global health status, physical function, and fatigue at week 16 (W16), with a one-sided type I error of 0.017 for each dimension. The primary HRQoL analysis was performed in patients with available baseline and W16 scores for the dimensions (ie, the modified intention-to-treat population 1 [mITT1]), and secondary longitudinal HRQoL analyses using the mixed model for repeated measures (MMRM) and time until definitive deterioration (TUDD) methods were performed in the mITT1 population and in patients with baseline and at least one follow-up questionnaire (mITT2 population). A difference of ≥5 points was considered to be clinically relevant. Results: Of 326 included patients, 313 were randomized to the standard (n=157) or APA (n=156) arms. In the mITT1 population (n=172), the mean differences in global health status, physical function, and fatigue at W16 adjusted from baseline were −0.98 (SD, 23.9; P=.39), −2.08 (SD, 21.3; P=.26), and 4.16 (SD, 29.2; P=.17), respectively, showing a non–statistically significant benefit with APA. In the mITT2 population (n=259), APA was associated with statistically significant and clinically relevant improvement in 5 and 8 dimensions of the HRQoL in the longitudinal MMRM and TUDD analyses, respectively. Conclusions: APA improved several dimensions of HRQoL in patients with aPDAC receiving first-line chemotherapy and standard care.

Submitted May 24, 2023; final revision received July 22, 2023; accepted for publication July 27, 2023.

Author contributions: Concept and design: Neuzillet, Hammel, Anota. Data acquisition, analysis, or interpretation: All authors. Statistical analysis: Anota, Henriques. Administrative, technical, or material support: Neuzillet, Bouché, Tournigand, Chibaudel, Bauguion, Bengrine-Lefevre, Lopez-Trabada Ataz, Mabro, Metges, Péré-Vergé, Conroy, Lièvre, Andre, Desseigne, Goldwasser, Hammel. Supervision: Neuzillet, Hammel. Writing—original draft: Neuzillet, Hammel, Anota, Henriques. Writing—review & editing: All authors.

Disclosures: Dr. Neuzillet has disclosed receiving honoraria from and serving as a consultant for Amgen, AstraZeneca, Baxter, Bristol Myers Squibb, Fresenius Kabi, Incyte, Merck & Co., MSD, Mundipharma, Novartis, Nutricia, Pierre Fabre, Roche, Sanofi, Servier, and Viatris; and receiving grant/research support from AstraZeneca, Fresenius Kabi, Nutricia, OSE Immunotherapeutics, Roche, Servier, and Viatris. Dr. Bouché has disclosed serving on the speaker’s bureau or as a consultant for Merck KGaA, Apmonia Therapeutics, Bayer, Grünenthal, MSD, Amgen, Servier, and Pierre Fabre. Dr. Chibaudel has disclosed serving on the speaker’s bureau or as a consultant for Amgen, Bayer, BeiGene, Biocartis, Bristol Myers Squibb, Eli Lilly & Co., Merck & Co., MSD, Pfizer, Pierre Fabre, Roche, Sanofi, SeqOne, Servier, and Takeda. The remaining authors have disclosed that they have not received any financial consideration from any person or organization to support the preparation, analysis, results, or discussion of this article.

Funding: Research reported in this publication was supported by GERCOR (C. Neuzillet) and ARCAD Foundation (C. Neuzillet).

Correspondence: Cindy Neuzillet, MD, Department of Medical Oncology, Institut Curie – Site Saint Cloud, 35 Rue Dailly, 92210 Saint Cloud, France. Email: cindy.neuzillet@curie.fr

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Print ISSN:
1540-1405
Online ISSN:
1540-1413
Publisher:
National Comprehensive Cancer Network
Cover Journal of the National Comprehensive Cancer Network
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Copyright:
Copyright © 2023 by the National Comprehensive Cancer Network 2023
Article Category:
Research Article
Received:
24 May 2023
Accepted:
27 Jul 2023
Print Publication Date:
01 Dec 2023
Online Publication Date:
Dec 2023
Keywords:
adapted physical activity; pancreatic cancer; health-related quality of life; first-line chemotherapy; PDAC

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