Physical activity program in patients with metastatic colorectal cancer who receive palliative first-line chemotherapy: A randomized controlled phase III trial—(ACTIVE-2 SAKK 41/14).
2018; Lippincott Williams & Wilkins; Volume: 36; Issue: 15_suppl Linguagem: Inglês
10.1200/jco.2018.36.15_suppl.tps3621
ISSN1527-7755
AutoresViviane Hess, Ralph C. Winterhalder, Karin Ribi, Barbara Handschin, Stefanie Pederiva, Jean-Marc Lüthi, Marc Kueng, Daniel Helbling, Peter Moosmann, Pierre Bohanes, Bernhard C. Pestalozzi, Evelyn Rickenbacher, Christine Biaggi Rudolf, Catherine Berset, Stéphanie Rondeau, Daniel Horber, Josef Thaler,
Tópico(s)Neutropenia and Cancer Infections
ResumoTPS3621 Background: Exercise has become a main focus of basic and clinical research worldwide during the current pandemic of physical inactivity. A clear link between inactivity and cancer incidence/relapse has been established, particularly for colon cancer, the third most common cancer. However, whether exercise has an impact on disease course and survival in advanced disease is unknown. Exercise modifies key host factors that are determinants of chemotherapy efficacy such as metabolic and immunologic tumor microenvironment, drug tolerability and treatment adherence. Thus, we aim to assess whether a supervised exercise program concomitant to first-line palliative chemotherapy for patients with metastatic colorectal cancer (mCRC) enhances chemotherapy efficacy and, therefore, increases survival and decreases symptom burden as compared to patients treated with chemotherapy alone. Methods: Patients with newly diagnosed mCRC are stratified (pre-diagnosis physical fitness, RAS-mutational status, primary tumor location, alkaline phosphatase levels) and randomly assigned to undergo standard systemic treatment and care-as-usual or standard systemic treatment combined with a 12-week structured physical activity (PA) program with twice weekly supervised, heart-rate guided interval training on a bike ergometer. Both groups undergo regular imaging with CT/MRI in order to assess the 1°endpoint of progression-free survival (PFS), i.e. the time between diagnosis and disease progression or death. Radiologists who are blinded to the group assignment will review imaging. A total of 439 events occurring in 524 patients will be needed to show a clinically meaningful HR of 0.75 for PFS with 80% power and an α of 0.03. Co-primary endpoint is self-reported symptom burden as measured by the revised Edmonton Symptom Assessment Scale (rESAS). 50 patients from 17 Swiss and Austrian Centers have been randomized. A planned feasibility analysis of the first 40 patients is ongoing. Clinical trial information: NCT02597075.
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