Health-related quality of life in premenopausal women with hormone-receptor-positive, HER2-negative advanced breast cancer treated with ribociclib plus endocrine therapy: results from a phase III randomized clinical trial (MONALEESA-7)
Journal
Therapeutic Advances in Medical Oncology
Journal Volume
12
Date Issued
2020
Author(s)
Harbeck N.
Franke F.
Villanueva-Vazquez R.
Tripathy D.
Chow L.
Babu G.K.
Im Y.-H.
Chandiwana D.
Gaur A.
Lanoue B.
Rodriguez-Lorenc K.
Bardia A.
Abstract
Background: This analysis evaluated patient-reported outcomes (PROs) to assess health-related quality of life (HRQoL) in the phase III MONALEESA-7 trial, which previously demonstrated improvements in progression-free survival (PFS) and overall survival (OS) with ribociclib (cyclin-dependent kinase 4/6 inhibitor) + endocrine therapy (ET) compared with placebo + ET in pre- and perimenopausal patients with hormone-receptor-positive, HER2-negative (HR+/HER2?) advanced breast cancer (ABC). Methods: The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire C30 (QLQ-C30) and the EQ-5D-5L were used to evaluate HRQoL. Results: EORTC QLQ-C30 assessments were evaluable for 335 patients in the ribociclib arm and 337 patients in the placebo arm. Adherence rates at baseline and ?1 postbaseline time point were 90% and 83%, respectively. Patients treated with ribociclib + ET had a longer time to deterioration (TTD) ? 10% in global HRQoL {hazard ratio (HR), 0.67 [95% confidence interval (CI), 0.52–0.86]}. TTD ? 10% in global HRQoL was delayed in ribociclib-treated patients without versus with disease progression [HR, 0.31 (95% CI, 0.21–0.48)]. TTD ? 10% in pain was longer with ribociclib + ET than with placebo + ET [HR, 0.65 (95% CI, 0.45–0.92)]. Patients who received a nonsteroidal aromatase inhibitor experienced similar benefits with ribociclib versus placebo in global HRQoL and pain. Conclusion: HRQoL was maintained longer in patients who received ribociclib + ET versus placebo + ET. These data, combined with previously reported improvements in PFS and OS, support a strong clinical benefit-to-risk ratio with ribociclib-based treatment in pre- and perimenopausal patients with HR+/HER2? ABC. ? The Author(s), 2020.
Subjects
breast cancer; endocrine therapy; quality of life; ribociclib
SDGs
Other Subjects
anastrozole; cyclin dependent kinase 6; hormone receptor; letrozole; placebo; ribociclib; adult; Article; cancer hormone therapy; cancer patient; cancer therapy; controlled study; disease exacerbation; European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30; female; global health; human; human epidermal growth factor receptor 2 negative breast cancer; major clinical study; overall survival; patient-reported outcome; phase 3 clinical trial; premenopause; priority journal; progression free survival; prospective study; quality of life; randomized controlled trial
Publisher
SAGE Publications Inc.
Type
journal article