Health-Related QOL Not Compromised
Initial study results reported that everolimus plus exemestane results in a higher rate of grade 3 or 4 toxicity compared with placebo plus exemestane. Although per-protocol patient-reported health-related QOL data from BOLERO-2 are limited, J. Thaddeus Beck, MD, of the Highlands Oncology Group, Fayetteville, AR, and colleagues reported on additional post-hoc analyses of these outcomes, which demonstrated that everolimus plus exemestane did not compromise health-related QOL.3
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Using the European Organization for Research and Treatment of Cancer (EORTC) QLQ‑C30 questionnaire, the investigators assessed health-related QOL at baseline and every following 6 weeks until disease progression. The QLQ‑C30 comprises 30 items combined into 15 subscales, including Global Health Status; higher scores (range, 0 to 100) indicate better health-related QOL.
The protocol specified a time to definitive deterioration (TTD) analysis at a 5% decrease in QOL relative to baseline, with no subsequent increase above this threshold. Additional sensitivity analyses were conducted using 10-point minimally important difference (MID) decreases in QLQ‑C30 score relative to baseline.
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, ECOG performance status, prognostic factors, and treatment history were used to compare treatment arms.
Baseline QLQ‑C30 Global Health Status scores were 64.7 in the everolimus plus exemestane group compared with 65.3 in the placebo plus everolimus group (difference -0.7 [95% CI; -4.3‑3.0]), Dr. Beck reported, which was not statistically significant. Median TTD in health-related QOL was 8.3 months (95% CI; 7.0‑9.7) for patients in the everolimus plus exemestane arm vs 5.8 months (95% CI; 4.2, 7.2) for placebo plus everolimus (P=0.0084); adjusted HR was 0.74 (95% CI; 0.58‑0.95).
At the 10-point MID, median TTD for everolimus plus exemestane was 11.7 months (95% CI; 9.7‑13.3) vs 8.4 months (95% CI; 6.6‑12.5) for placebo plus everolimus; adjusted HR was 0.80 (95% CI; 0.61‑1.06), Dr. Beck noted.
These results demonstrated that everolimus plus exemestane did not compromise health-related QOL in patients with HR+ advanced breast cancer.
