Physical Activity Supervision Does Not Up QOL in Metastatic Cancer

A home-based supervised physical activity plan was feasible but did not show improvement to quality of life (QOL) or fatigue vs recommended adapted physical activity guided by a booklet in patients with metastatic cancer receiving oral targeted therapy, according to findings from the AFSOS-Unicancer QUALIOR trial (NCT03169075) presented at the 2025 European Society for Medical Oncology (ESMO) Congress.

Results were shared by Florence Joly Lobbedez, MD, PhD, of the medical oncology department at Centre Francois Baclesse in Caen, France.

“This is one of the few randomized studies conducted in patients with metastatic cancer and the first one focused on patient treated with oral targeted therapy treatments,” Lobbedez said in his presentation. “A home-based supervised physical activity program in this population is feasible. Our primary endpoint was not met, and we didn’t see statistically significant difference with the other quality of life questionnaire. However, the patient in the program increased their physical activity level and reported better trajectory with the visual analogue scale of fatigue and energy.”

Following up on phase 2 data presented at ESMO in 2021 that showed that the program was feasible, phase 3 results presented this year showed that among 190 patients who were randomized—126 of whom underwent supervised physical activity and 64 of whom were in the control arm—and 128 who were analyzed, no difference in FACT-F score was observed at 3 months, with a mean difference of 1.3 (95% CI, -1.9 to 4.4; P = .44) adjusted on baseline score.

While at 3 months fewer patients in supervised physical activity arm reported visual analog scale loss of energy (45% vs 62%), no longitudinal differences in health-related QOL (HR-QOL), cognition, anxiety, or depression were observed between the 2 arms.

Noting that the study was under-powered due to what she described as difficulties with human resources, Lobbedez concluded her presentation by calling for further research on this topic.

“We need other clinical trials if we want to definitively conclude if this type of program at home for metastatic patients [with cancer] is viable and efficient,” she said.

More Details on the AFSOS-Unicancer QUALIOR Study

“Oral targeted therapy is nowadays largely prescribed to treat patients with metastatic cancer,” Lobbedez said. “It is widely used for a mixed range of cancer, but the main [adverse] effect induced by this treatment is fatigue, and there is some impact on patient compliance to treatment and deterioration in quality of life [as a result]. In parallel, we know that physical activity is beneficial, and we have many studies that show us now that we can reduce fatigue with physical activity and improve quality of life, but most studies are realized among patients who have localized cancer. And in fact, there are few studies conducted among patients with metastatic cancer, and the results are really mitigated. So that's why we designed this study.”

In the study, patients’ median age was 58 (range, 29-84) in the supervised physical activity arm and 59 (range, 31-79) in the control arm. In the respective arms, 87% and 89% of patients were female, and most patients (64% vs 60%) had an ECOG performance status of 0. Most patients had metastatic breast cancer (73% vs 67%), were treated with a CDK inhibitor (61% vs 62%), were receiving their first line of metastatic treatment (84% vs 82%).

The study was conducted from July 2017 to July 2023, according to Lobbedez’s presentation. Patients in the experimental supervised physical activity arm participated in a program developed by specialized coaches involved in physical activity and cancer and trained for the trial. The program included 1 standardized at-home supervised session with a specialized coach and 2 non-supervised sessions every week for 3 months, and intensification of the program was possible, according to patients’ progression, and follow-up and progression were reported in a standardized grid. On the other hand, patients in the control arm received a booklet containing advice about exercise.

Reference

Lobbedez FJ, Lefeuvre-Plesse C, Helissey CFA, et al. Home-based supervised physical activity (SPA) for metastatic cancer patients receiving oral targeted therapy: the AFSOSUnicancer QUALIOR randomized phase III study. Presented at: 2025 European Society for Medical Oncology Congress; October 17-21, 2025; Berlin, Germany. Abstract 2802O