539 Background: BOLERO-2, a phase III study, randomized 724 patients with hormone-receptor–positive metastatic breast cancer, who had recurrence or progression on/after prior nonsteroidal aromatase inhibitor therapy, to everolimus (EVE) plus exemestane (EXE) or EXE and placebo. A preplanned 12-month median time interim analysis demonstrated that EVE+EXE significantly improved progression-free survival (PFS) vs EXE+placebo but that EVE+EXE resulted in a higher rate of grade 3/4 toxicity. Per-protocol patient reported health-related quality-of-life (HRQoL) data are limited; here we report on additional post-hoc analyses of these outcomes. Methods: Using the EORTC–QLQ‑C30 questionnaire, HRQoL was assessed at baseline and every 6 weeks thereafter until progression. The QLQ‑C30 consists of 30 items combined into 15 subscales, including a Global Health Status (GHS) where higher scores (range 0 to 100) indicate better HRQoL. This analysis included a protocol-specified time to definitive deterioration (TTD) analysis at a 5% decrease in QoL relative to baseline, with no subsequent increase above this threshold. We report additional sensitivity analyses using 10-point minimally important difference (MID) decreases in QLQ‑C30 score relative to baseline. Treatment arms were compared using a stratified logrank test and a Cox proportional hazards model adjusted for trial stratum (visceral metastases and previous hormone sensitivity), age, sex, race, baseline score and ECOG performance status, prognostic factors, and treatment history. Results: Baseline QLQ‑C30 GHS scores were not statistically significantly different across treatment groups (64.7 vs 65.3; difference -0.7 [95% CI; -4.3, 3.0]). The median TTD in HRQoL was 7.0 months (95% CI; 5.6, 8.3) for EVE+EXE vs 5.6 (95% CI; 4.2, 7.0) for EXE (P = .0792). Adjusted HR (0.80) approached significance (95% CI; 0.63, 1.02). At the 10-point MID, median TTD for EVE+EXE was 9.7 months (95% CI; 8.3, 11.2) vs 8.4 months (95% CI; 6.3, 12.5) for EXE. Adjusted HR was 0.90 (95% CI; 0.69, 1.18). Conclusions: These additional analyses demonstrate that in addition to significantly improving PFS, EVE+EXE does not compromise HRQoL.
Impacts of Adverse Events on Health-Related Quality of Life in Patients Receiving First-Line Chemotherapy for Metastatic Breast Cancer: Results From Randomized Phase III Select BC Study
