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)

摘要

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.