• Mario Campone, J Thaddeus Beck, Michael Gnant, Patrick Neven, Kathleen I Pritchard, Thomas Bachelot, Louise Provencher, Hope S Rugo, Martine Piccart, Gabriel N Hortobagyi, Martina Nunzi, Daniel Y C Heng, José Baselga, Anna Komorowski, Shinzaburo Noguchi, Jun Horiguchi, Lee Bennett, Ryan Ziemiecki, Jie Zhang, Ayelet Cahana, Tetiana Taran, Tarek Sahmoud, and Howard A Burris.
• Institut de Cancérologie de l'Ouest - Centre Rene Gauducheau , Saint Herblain , France.
• Curr Med Res Opin. 2013 Nov 1; 29 (11): 1463-73.

ObjectiveEverolimus (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 MethodsHRQOL 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 RegistrationClinicaltrials.gov: NCT00863655.Main Outcome MeasuresProgression-free survival, survival, response rate, safety, and HRQOL.ResultsLinear 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.Key LimitationsHRQOL data were not collected after disease progression.ConclusionsThese 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.

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