Abstract P1-19-06: Patient-reported outcomes, including work productivity, from the MONALEESA-7 trial of ribociclib plus endocrine therapy in patients with HR+/HER2− advanced breast cancer
Authors: Harbeck Nadia , Hurvitz Sara , Bardia Aditya , Franke Fabio , Babu K. Gonvind , Wheatley-Price Paul , Im Young-Hyuck , Altundag Kadri , Ridolfi Antonia , Chandiwana David , Lanoue Brad , Menon Lakshmi , Tripathy Debu 
Published: March 2020

Background: MONALEESA-7 is a Phase III study (NCT02278120) and the only dedicated trial of endocrine therapy (ET) ± a cyclin-dependent kinase 4/6 inhibitor in premenopausal patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2−) advanced breast cancer (ABC). The study demonstrated that the addition of ribociclib (RIB) to a nonsteroidal aromatase inhibitor (NSAI) or tamoxifen (TAM) + goserelin (GOS) significantly extended both progression-free survival (PFS; hazard ratio, 0.55; Tripathy D et al. Lancet Oncol. 2018) and overall survival (OS; hazard ratio, 0.71; Im S-A et al. N Engl J Med. 2019). Health-related quality of life (HRQOL) and work productivity are other important aspects of clinical benefit, especially in the premenopausal population. We present analyses of QOL and work productivity from MONALEESA-7. Methods: Premenopausal or perimenopausal patients with HR+/HER2− ABC were treated with RIB or placebo (PBO) + GOS with either an NSAI (letrozole or anastrozole) or TAM. A secondary endpoint was evaluation of patient-reported outcomes (PROs) for HRQOL using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire core 30 (QLQ-C30). Assessments included global health status as well as social, emotional, and physical functioning. Description of Work Productivity and Activity Impairment (WPAI) was an exploratory endpoint and was measured using the WPAI Questionnaire: General Health (WPAI:GH; V2.0). Results: Time to deterioration (TTD) ≥ 10% in EORTC QLQ-C30 global health status was prolonged with RIB vs PBO (median, 35.8 vs 23.3 months; hazard ratio, 0.665 [95% CI, 0.517-0.855]). TTD ≥ 10% in emotional functioning was also prolonged with RIB vs PBO (hazard ratio, 0.636 [95% CI, 0.488-0.828]), as was TTD ≥ 10% in social functioning (hazard ratio, 0.813 [95% CI, 0.610-1.084]) and TTD ≥ 10% in physical functioning (hazard ratio, 0.715 [95% CI, 0.526-0.972]). Compliance rates with the WPAI:GH were &gt; 99% at baseline and &gt; 98% at the end of treatment. Neither arm had an increase from baseline to the end of treatment in mean percentage of work missed due to overall health. Change in percent activity impairment due to overall health was comparable between treatment arms, as were change in percent impairment while working due to overall health and percent overall work impairment due to overall health. The trends observed with RIB vs PBO in the EORTC QLQ-C30 and WPAI:GH in the overall population were generally similar in the NSAI cohort. Conclusions: WPAI and global health are important considerations in the premenopausal patient population. Analysis of PROs demonstrated that TTD ≥ 10% in global health status and emotional functioning were prolonged with RIB vs PBO. Social and physical functioning were maintained in both treatment arms. Results in various WPAI domains demonstrated that productivity was also maintained in both groups. These QOL and WPAI results, in addition to the significantly longer PFS and OS results with RIB vs PBO, indicate a substantial clinical benefit with RIB treatment in premenopausal patients with HR+/HER2− ABC.

Citation Format: Nadia Harbeck, Sara Hurvitz, Aditya Bardia, Fabio Franke, K. Gonvind Babu, Paul Wheatley-Price, Young-Hyuck Im, Kadri Altundag, Antonia Ridolfi, David Chandiwana, Brad Lanoue, Lakshmi Menon, Debu Tripathy. Patient-reported outcomes, including work productivity, from the MONALEESA-7 trial of ribociclib plus endocrine therapy in patients with HR+/HER2− advanced breast cancer [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P1-19-06.