Health-related quality of life of patients with advanced breast cancer treated with everolimus plus exemestane versus placebo plus exemestane in the phase 3, randomized, controlled, BOLERO-2 trial.

摘要: BACKGROUND: The randomized, controlled BOLERO-2 (Breast Cancer Trials of Oral Everolimus) trial demonstrated significantly improved progression-free survival with the use everolimus plus exemestane (EVE + EXE) versus placebo (PBO in patients advanced breast cancer who developed disease progression after treatment nonsteroidal aromatase inhibitors. This analysis investigated effects on health-related quality life (HRQOL). METHODS: Using European Organisation for Research and Treatment Quality Life Questionnaire-Core 30 (EORTC QLQ-C30) questionnaire, HRQOL was assessed at baseline every 6 weeks thereafter until and/or discontinuation. The items 15 subscales QLQ-C30 include global health status wherein higher scores (range, 0-100) indicate better HRQOL. included a protocol-specified time to definitive deterioration (TDD) 5% decrease baseline, no subsequent increase above this threshold. authors report additional sensitivity analyses using 10-point minimal important difference decreases score baseline. arms were compared stratified log-rank test Cox proportional hazards model adjusted stratum (visceral metastases, previous hormone sensitivity), age, sex, race, Eastern Cooperative Oncology Group performance status, prognostic risk factors, history. RESULTS: Baseline found be similar between groups (64.7 vs 65.3). median TDD 8.3 months EVE EXE 5.8 PBO (hazard ratio, 0.74; P = .0084). At difference, 11.7 8.4 0.80; .1017). CONCLUSIONS: In develop inhibitors, associated longer EXE. 2013. © 2013 American Society.