Health-related quality of life and disease symptoms in postmenopausal women with HR+, HER2advanced breast cancer treated with everolimus plus exemestane versus exemestane monotherapy Academic Article uri icon

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  • 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. 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: NCT00863655. MAIN OUTCOME MEASURES: Progression-free survival, survival, response rate, safety, and HRQOL. 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. KEY LIMITATIONS: HRQOL data were not collected after disease progression. 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.


  • Campone, Mario
  • Beck, J Thaddeus
  • Gnant, Michael
  • Neven, Patrick
  • Pritchard, Kathleen
  • Bachelot, Thomas
  • Provencher, Louise
  • Rugo, Hope S
  • Piccart, Martine
  • Hortobagyi, Gabriel N
  • Nunzi, Martina
  • Heng, Daniel YC
  • Baselga, José
  • Komorowski, Anna
  • Noguchi, Shinzaburo
  • Horiguchi, Jun
  • Bennett, Lee
  • Ziemiecki, Ryan
  • Zhang, Jie
  • Cahana, Ayelet
  • Taran, Tetiana
  • Sahmoud, Tarek
  • Burris, Howard A

publication date

  • November 2013

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