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. (November 2013)

• Record Type: Journal Article
• Authors: Campone, Mario; Beck, J. Thaddeus; Gnant, Michael; Neven, Patrick; Pritchard, Kathleen I.; Bachelot, Thomas; Provencher, Louise; Rugo, Hope S.; Piccart, Martine; Hortobagyi, Gabriel N.; Nunzi, Martina; Heng, Daniel Y.C.; Baselga, José; Komorowski, Anna; Noguchi, Shinzaburo; Horiguchi, Jun; Bennett, Lee; Ziemiecki, Ryan; Zhang, Jie; Cahana, Ayelet; Taran, Tetiana; Sahmoud, Tarek; Burris, Howard A.
• Is Part Of: Current medical research and opinion. Volume 29:Number 11(2013:Nov.)
• Page Start: 1463
• Page End: 1473
• Publication Date: 2013-11
• Subjects: Clinical medicine -- Periodicals; Therapeutics -- Periodicals; 615.5
• DOI: 10.1185/03007995.2013.836078
• Languages: English
• ISSNs: 0300-7995

Abstract

<abstract> <title>Abstract</title> <sec id="ss1"> <title>Objective:</title> <p>Everolimus (EVE)+exemestane (EXE; <italic>n</italic> = 485) more than doubled median progression-free survival versus placebo (PBO) + EXE (<italic>n</italic> = 239), with a manageable safety profile and no deterioration in health-related quality-of-life (HRQOL) in patients with hormone-receptor-positive (HR<sup>+</sup>) 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 <italic>post-hoc</italic> analyses of patient-reported HRQOL.</p> </sec> <sec id="ss2"> <title>Research design and methods:</title> <p>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.</p> </sec> <sec id="ss3"> <title>Clinical trial registration:</title> <p>Clinicaltrials.gov: NCT00863655.</p> </sec> <sec id="ss4"> <title>Main outcome measures:</title> <p>Progression-free survival, survival, response rate, safety, and HRQOL.</p> </sec> <sec id="ss5"> <title>Results:</title> <p>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.</p> </sec> <sec id="ss6"> <title>Key limitations:</title> <p>HRQOL data were not collected after disease progression.</p> </sec> <sec id="ss7"> <title>Conclusions:</title> <p>These analyses confirm that EVE + EXE provides clinical benefit without adversely impacting HRQOL in patients with HR<sup>+</sup> ABC who recurred/progressed on prior NSAIs versus endocrine therapy alone.</p> </sec> </abstract>