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

作者：Campone Mario^*; Beck J Thaddeus; Gnant Michael; Neven Patrick; Pritchard Kathleen I; Bachelot Thomas; Provencher Louise; Ruge Hope S; Piccart Martine; Hortobagyi Gabriel N; Nunzi Martina; Heng Daniel Y C; Baselga Jose; Komorowski Anna; Noguchi Shinzaburo; Horiguchi Jun; Bennett Lee; Ziemiecki Ryan; Zhang Jie; Cahana Ayelet; Taran Tetiana; Sahmoud Tarek; Burris Howard A III

来源：Current Medical Research and Opinion, 2013, 29(11): 1463-1473.

DOI：10.1185/03007995.2013.836078

• Advanced breast cancer
• Everolimus
• Exemestane
• Health-related quality of life
• Hormone receptor positive

Objective: 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. %26lt;br%26gt;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. %26lt;br%26gt;Clinical trial registration: Clinicaltrials. gov: NCT00863655. %26lt;br%26gt;Main outcome measures: Progression-free survival, survival, response rate, safety, and HRQOL. %26lt;br%26gt;Results: 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. %26lt;br%26gt;Key limitations: HRQOL data were not collected after disease progression. %26lt;br%26gt;Conclusions: These analyses confirm that EVE+EXE provides clinical benefit without adversely impacting HRQOL in patients with HR+ABC who recurred/progressed on prior NSAIs versus endocrine therapy alone.

• 出版日期2013-11