Abstract 1680P
Background
If physical activity is already systematically proposed as part of supportive care in localized cancer patients, the implementation for metastatic patients remains a challenge. QUALIOR is a 2-part, randomized, open-label, multicenter trial which aims to assess the feasibility and the efficacy of supervised home-based SPA for metastatic cancer patients receiving oral targeted therapy (phase II: n=120; phase III: n=256). The results of the phase II study are presented here.
Methods
Patients were randomized in a 2:1 ratio to a 3-month SPA (experimental arm) or to a recommended adapted physical activity (control arm). The feasibility was assessed using the rate of patients that participated adequately in the SPA. The SPA participation was considered sufficient if 45 patients or more performed at least 50% of the theoretically planned sessions within 3 months (i.e. one home supervised session with a sport specialized coach and 2 non-supervised sessions per week). Efficacy endpoint was fatigue using the FACT-F questionnaire at baseline, every month during SPA and then every 3 months during the first year of follow-up. The analysis was performed as an intent-to-treat (ITT) analysis.
Results
Between 2017 and 2020, 129 patients were randomized. Among the 112 patients of the ITT population (74 in SPA arm and 38 in control arm), mean age was 59 (sd 13) and the main cancer site was breast (n=64, 57%). Targeted therapy was associated with hormone-therapy in 45 patients (61%) in SPA arm, versus 17 patients (45%) in control arm. In the SPA arm, 45 patients (61%) performed at least 50% of the theoretically planned sessions, 27 patients (36%) performed less than 50% and only 2 patients did not perform any physical activity. One hundred patients (89%) completed the baseline FACT-F questionnaire. At 3-month, mean scores FACT-F were 38.8 (sd 10) and 36.7 (sd 10) in SPA arm and control arm, respectively.
Conclusions
The QUALIOR study showed that the home-based SPA is feasible among metastatic cancer patients treated with oral targeted therapy. The efficacy analysis is still ongoing.
Clinical trial identification
Protocol number 2015-A01922-47, authorized by French authorities.
Editorial acknowledgement
Legal entity responsible for the study
UNICANCER.
Funding
La Ligue Contre le Cancer.
Disclosure
All authors have declared no conflicts of interest.