Health-related quality of life and disease symptoms in postmenopausal women with HR+, HER2- advanced breast cancer treated with everolimus plus exemestane versus exemestane monotherapy
Everolimus (EVE)+exemestane (EXE; n?=?485) more than doubled median progression-free survival versus placebo (PBO)?+?EXE (n?=?239), with a manageable safety profile and no deterioration in health-related quality-of-life (HRQOL) in patients with hormone-receptor-positive (HR+) advanced breast cancer (ABC) who recurred or progressed on/after nonsteroidal aromatase inhibitor (NSAI) therapy. To further evaluate EVE?+?EXE impact on disease burden, we conducted additional post-hoc analyses of patient-reported HRQOL.
Research design and methods:
HRQOL was assessed using EORTC QLQ-C30 and QLQ-BR23 questionnaires at baseline and every 6 weeks thereafter until treatment discontinuation because of disease progression, toxicity, or consent withdrawal. Endpoints included the QLQ-C30 Global Health Status (QL2) scale, the QLQ-BR23 breast symptom (BRBS), and arm symptom (BRAS) scales. Between-group differences in change from baseline were assessed using linear mixed models with selected covariates. Sensitivity analysis using pattern-mixture models determined the effect of study discontinuation on/before week 24. Treatment arms were compared using differences of least squares mean (LSM) changes from baseline and 95% confidence intervals (CIs) at each timepoint and overall.
Clinical trial registration:
Main outcome measures:
Progression-free survival, survival, response rate, safety, and HRQOL.
Linear mixed models (primary model) demonstrated no statistically significant overall difference between EVE?+?EXE and PBO?+?EXE for QL2 (LSM difference?=??1.91; 95% CI?=??4.61, 0.78), BRBS (LSM difference?=??0.18; 95% CI?=??1.98, 1.62), or BRAS (LSM difference?=??0.42; 95% CI?=??2.94, 2.10). Based on pattern-mixture models, patients who dropped out early had worse QL2 decline on both treatments. In the expanded pattern-mixture model, EVE?+?EXE-treated patients who did not drop out early had stable BRBS and BRAS relative to PBO?+?EXE.