TY  - JOUR
IS  - 9_Supp
ID  - uneatlantico14247
JF  - Cancer Research
AV  - none
SP  - GS02
N2  - INTRODUCTION:

Patients with metastatic breast cancer (mBC) often experience cancer- and treatment-related side effects that can impair daily life activities and health-related quality of life (HRQoL). Interventions are needed that improve HRQoL by alleviating fatigue and other side effects during palliative BC cancer treatment. Recent evidence-based international guidelines (ASCO, ACSM) recommend exercise for patients with BC during adjuvant treatment for reducing side effects. However, evidence of the effectiveness of exercise in patients with mBC is scarce. The PREFERABLE-EFFECT study (NCT04120298) was designed to assess the effects of a 9-month supervised exercise program in patients with mBC on fatigue, HRQoL, and other cancer- and treatment-related side effects.

METHODS:

PREFERABLE-EFFECT is a multinational, randomized controlled trial including patients with mBC from five European countries (Germany, Poland, Spain, Sweden, The Netherlands) and Australia. Participants were randomly assigned to usual care or an individualized, structured exercise program consisting of aerobic, resistance, and balance training. The first six months included twice weekly supervised exercise sessions of one hour. In the last three months, one supervised session was replaced by an unsupervised session, supplemented by an exercise App. All participants received general exercise advice (physical activity ? 30 min/day) and an activity tracker. Our primary outcomes, physical fatigue (subscale of the EORTC QLQ-FA12) and HRQoL (summary score of the EORTC QLQ-C30), were assessed at baseline, 3, 6, and 9 months. Among other physical fitness outcomes, maximal short exercise capacity was assessed with the Steep Ramp Test. The intervention effects (intention-to-treat) were determined by comparing the change from baseline to 3, 6 (i.e., primary endpoint) and 9 months between groups using separate mixed models for repeated measures, adjusted for baseline values of the outcome variable and stratification factors (mBC line of treatment (1st/2nd vs. 3rd or higher) and study center). A significant improvement of either or both primary outcomes (applying the Bonferroni-Holm method) was considered as successful.

RESULTS:

Between 2019-2022, we included 357 patients with mBC, with 178 patients randomized to the exercise intervention and 179 to usual care. Patients were, on average, 55.4 years of age (SD=11.1), most patients received 1st or 2nd line of treatment at study enrollment (74.8%) and had bone metastases (73.9%). At 6 months (primary endpoint), participation in the exercise intervention resulted in statistically significant positive effects on both primary outcomes, compared to usual care: physical fatigue was lower (mean difference: -5.3, 95% CI -10.0; -0.6, p=0.027, effect size (ES)=0.22) and HRQoL was better (+4.8, 95% CI 2.2; 7.4, p=0.0003, ES=0.33). Beneficial effects were also found at 3 months (physical fatigue: -3.4, -7.8; 1.0, ES=0.14 and QoL: 3.9, 1.5; 6.3, ES=0.27) and 9 months (physical fatigue: -5.6, -10.9; -0.4, ES=0.24 and QoL: +4.3, 1.4; 7.3, ES=0.31). Further, at the primary endpoint, we found positive exercise effects on physical fitness (+24.3 Watts, 15.5; 33.1, ES=0.42) and numerous QLQ-C30 scales, including social functioning (+5.5, 0.2; 10.8, ES=0.20), pain (-7.1, -12.1; -1.9, ES=0.28) and dyspnea (-7.6, -12.2; -3.0, ES=0.28). Two SAEs occurred (one wrist fracture and one sacral stress fracture), neither related to bone metastases.

CONCLUSION:

This large multinational study demonstrated significant beneficial effects of a supervised exercise intervention offered during palliative treatment on mBC patients? fatigue, HRQoL, and other clinically relevant outcomes. Based on these findings, we recommend supervised resistance and aerobic exercise as part of supportive care regimens during palliative treatment of mBC.
TI  - Abstract GS02-10: Effects of a structured and individualized exercise program on fatigue and health-related quality of life in patients with metastatic breast cancer: the multinational randomized controlled PREFERABLE-EFFECT study
EP  - 10
Y1  - 2024/05//
SN  - 1538-7445
UR  - http://doi.org/10.1158/1538-7445.SABCS23-GS02-10
A1  - May, Anne
A1  - Hiensch, Anouk
A1  - Depenbusch, Johanna
A1  - Schmidt, Martina
A1  - Monninkhof, Evelyn
A1  - Peláez, Mireia
A1  - Clauss, Dorothea
A1  - Zimmer, Philipp
A1  - Belloso, Jon
A1  - Trevaskis, Mark
A1  - Rundqvist, Helene
A1  - Wiskemann, Joachim
A1  - Muller, Jana
A1  - Fremd, Carlo
A1  - Altena, Renske
A1  - Kufel-Grabowska, Joanna
A1  - Bijlsma, Rhode
A1  - van Leeuwen-Snoeks, Lobke
A1  - Bokkel-Huinink, Daan ten
A1  - Sonke, Gabe
A1  - Mann, Bruce
A1  - Francis, Prudence
A1  - Richardson, Gary
A1  - Álvarez, Isabel
A1  - Malter, Wolfram
A1  - Van der Wall, Elsken
A1  - Aaronson, Neil
A1  - Senkus, El?bieta
A1  - Urriticoechea, Ander
A1  - Zopf, Eva
A1  - Bloch, Wilhelm
A1  - Stuiver, Martijn
A1  - Wengström, Yvonne
A1  - Steindorf, Karen
VL  - 84
ER  -