Abstract
PurposeEvaluate patient-reported outcomes (PROs) for postmenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−) advanced breast cancer treated with first-line ribociclib plus letrozole.MethodsIn the phase III MONALEESA-2 study (NCT01958021), 668 patients were randomized 1:1 to ribociclib (600 mg/day; 3-weeks-on/1-week-off) plus letrozole (2.5 mg/day) or placebo plus letrozole. PROs were assessed using the European Organisation for Research and Treatment of Cancer core quality-of-life (EORTC QLQ-C30) and breast cancer-specific (EORTC QLQ-BR23) questionnaires. Changes from baseline and time to deterioration in health-related quality of life (HRQoL) were analyzed using linear mixed-effect and stratified Cox regression models, respectively. Exploratory analysis of area-under-the-curve for change from baseline in pain score (AUC-pain) was performed.ResultsOn-treatment HRQoL scores were consistently maintained from baseline and were similar between arms. A clinically meaningful (> 5 points) reduction in pain score was observed as early as Week 8 and was maintained up to Cycle 15 in the ribociclib arm. A statistically significant increase in mean AUC-pain was also observed in the ribociclib arm. Scores for all other EORTC QLQ-C30 and EORTC QLQ-BR23 domains were maintained from baseline and were similar between arms.ConclusionsHRQoL was consistently maintained from baseline in postmenopausal women with HR+, HER2− advanced breast cancer receiving ribociclib plus letrozole and was similar to that observed in the placebo plus letrozole arm. Together with the improved clinical efficacy and manageable safety profile, these PRO results provide additional support for the benefit of ribociclib plus letrozole in this patient population.
Highlights
Ribociclib is an orally bioavailable, highly selective inhibitor of cyclin-dependent kinases (CDK) 4 and 6 (CDK4/6) [1]
Targeted combination therapies are associated with higher response rates and delayed progression in patients with HR+, HER2− advanced breast cancer when compared with single-agent endocrine therapy, but this approach can expose patients to additional treatmentrelated toxicities, which can affect their quality of life (QoL) [7]
In this analysis of the MONALEESA-2 study, we report validated patient-reported outcomes (PROs) results, including health-related QoL (HRQoL) and improvement in symptoms
Summary
Ribociclib is an orally bioavailable, highly selective inhibitor of cyclin-dependent kinases (CDK) 4 and 6 (CDK4/6) [1]. In the phase III MONALEESA-2 study, first-line treatment with ribociclib plus letrozole significantly prolonged progression-free survival (PFS) at the pre-planned interim analysis (hazard ratio: 0.556; 95% confidence interval [CI] 0.429–0.720; p = 0.00000329), showing higher overall response rates versus placebo plus letrozole in postmenopausal women with HR+, HER2− recurrent/metastatic breast cancer [4, 5]. Recent guidelines recommend that the impact of treatment on QoL should be considered in addition to efficacy and safety [9]. In this analysis of the MONALEESA-2 study, we report validated patient-reported outcomes (PROs) results, including health-related QoL (HRQoL) and improvement in symptoms
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