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)

• Published in: Therapeutic advances in medical oncology Vol. 12; p. 1758835920943065
• Main Authors: Harbeck, Nadia, Franke, Fabio, Villanueva-Vazquez, Rafael, Lu, Yen-Shen, Tripathy, Debu, Chow, Louis, Babu, Govind K, Im, Young-Hyuck, Chandiwana, David, Gaur, Anil, Lanoue, Brad, Rodriguez-Lorenc, Karen, Bardia, Aditya
• Format: Journal Article
• Language: English
• Published: London, England SAGE Publications 2020; Sage Publications Ltd; SAGE Publishing
• Subjects: Aromatase; Breast cancer; Cyclin-dependent kinase; Cyclin-dependent kinase 4; Cyclin-dependent kinases; Endocrine therapy; Enzyme inhibitors; ErbB-2 protein; Original Research; Pain; Patients; Quality of life; Survival; Targeted cancer therapy; breast cancer; quality of life; ribociclib; endocrine therapy
• ISSN: 1758-8359; 1758-8340; 1758-8359
• DOI: 10.1177/1758835920943065

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.