Maintenance of Health-Related Quality of Life in Elderly Patients Treated with Ribociclib + Letrozole in MONALEESA-2.

1041Background: First-line ribociclib + letrozole significantly prolongs progression-free survival vs letrozole alone in patients aged ≥65 y with hormone receptor–positive (HR+), HER2− advanced breast cancer (ABC). Despite the efficacy benefits observed with combination therapy, elderly patients may be receiving single-agent therapy because of toxicity and health-related quality of life (HRQoL) concerns. Here we present key HRQoL outcomes in patients aged ≥65 y in MONALEESA-2. Methods: Postmenopausal patients with HR+, HER2− ABC (N = 668) were randomized 1:1 to receive either first-line ribociclib 600 mg or placebo once daily (QD) for 3 wk on, 1 wk off, + letrozole 2.5 mg QD. Patient-reported outcomes were the EORTC QLQ-C30 questionnaire for overall HRQoL/symptom scores and the breast cancer–specific QLQ-BR23 questionnaire for breast symptom score; changes from baseline were determined by a linear mixed-effect model, including responses through treatment cycle 28 day 1 and at end of treatment. Time to 10%...