Health-related quality of life and physical activity collected via mobile application and wearable device in patients with HR +/HER2 − advanced breast cancer treated with palbociclib plus endocrine therapy or endocrine therapy alone: 6-month longitudinal study (JBCRG-26)

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OBJECTIVES: To summarize descriptively health-related quality of life (HRQOL) and physical activity (PA) evaluated with a mobile application and wearable device among patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR + /HER2 -) advanced breast cancer (ABC) treated with first- or second-line palbociclib plus endocrine therapy (ET) or ET alone. METHODS: HRQOL was assessed with the EORTC QLQ-C30 at baseline and Day 15 of 6 treatment cycles (~ 24 weeks). PA metrics were averaged on a weekly basis for 24 weeks. Co-primary endpoints were mean change from baseline in Global Health Status (GHS) and sedentary time. RESULTS: Ninety-nine patients were enrolled; 78 received palbociclib plus ET (mean age: 57.2 years; 75.6% initiated first-line treatment) and 21 received ET alone (mean age: 56.3 years; 90.5% initiated first-line treatment). Baseline mean GHS score was 60.9 in the palbociclib plus ET group and 64.3 in the ET alone group; mean changes from baseline to Day 15 of Cycle 6 were +4.8 and +2.9, respectively, and not deteriorated beyond the 10-point clinically significant threshold in either treatment group. Baseline mean sedentary time was 581 min/day in the palbociclib plus ET group and 513 min/day in the ET alone group; mean changes from baseline to Week 24 were -22 and -102 min/day, respectively. CONCLUSIONS: In this real-world study of women with HR+/HER2- ABC in Japan, neither palbociclib plus ET nor ET alone had any substantial detrimental impacts on HRQOL, according to patients' assessments recorded in a smartphone-based mobile application, and PA, as measured by a wearable device. TRIAL REGISTRATION: ClinicalTrials.gov NCT04736576; registered, February 3, 2021.

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