Health-related quality of life (HRQoL) in the phase III NATALEE study of adjuvant ribociclib (RIB) plus a nonsteroidal aromatase inhibitor (NSAI) vs NSAI alone in patients (pts) with HR+/HER2− early breast cancer (EBC)

Abstract

VP3-2023: Health-related quality of life (HRQoL) in the phase III NATALEE study of adjuvant ribociclib (RIB) plus a nonsteroidal aromatase inhibitor (NSAI) vs NSAI alone in patients (pts) with HR+/HER2− early breast cancer (EBC)

Published: September 14, 2023
DOI: https://doi.org/10.1016/j.annonc.2023.08.007
Download PDF

P.A. Fasching, D. Slamon, Z. Nowecki, I. Ferrusi... Z. Li, G.N. Hortobagyi
Show authors and affiliations

Background

NATALEE showed a statistically significant invasive disease-free survival benefit with RIB + NSAI vs NSAI alone in a broad population of pts with stage II/III HR+/HER2− EBC, including pts with no no dal involvement. In metastatic BC, all 3 MONALEESA trials reported maintained or improved HRQoL with the addition of RIB to endocrine therapy. Understanding the impact of HRQoL is critical for healthcare decision-making, particularly among pts with EBC. We present the prespecified HRQoL analysis in NATALEE.

Methods

Pts were randomized to RIB + NSAI (letrozole/anastrozole) or NSAI alone, (+ LHRH agonist for premenopausal women and men). HRQoL was assessed using pt-reported outcomes (PROs). Global health status (GHS) and physical, social, and emotional functioning of EORTC QLQ-C30; breast symptoms scale of EORTC QLQ-BR23; health on a visual analog scale (VAS) of EQ-5D-5L; and anxiety and depression from the Hospital Anxiety and Depression Scale were assessed. Physical functioning was the prespecified primary PRO. A linear effects model determined least squares mean change from baseline (BL). A prespecified regression analysis used a repeated measures model for assessments over time.

Results

All pts in NATALEE (RIB + NSAI, n = 2549; NSAI, n = 2552) were assessed. Noncompletion was low in the treatment period (≈ 2%-7%, both arms). For physical functioning, GHS, and VAS, a similar decrease from BL was observed (both arms) at first assessment (≈ 0.5 SD from BL). After the initial drop, curves stabilized with 1-point average difference between RIB + NSAI and NSAI. Regression analysis confirmed consistent HRQoL between arms over time adjusted for stratification factors (menopausal status, stage, prior neo[adjuvant] chemotherapy [CT], and geographic region). Premenopausal pts (vs post) and pts with prior neo(adjuvant) CT (vs none) tended to have higher physical functioning.

Conclusions

Scores for physical functioning and GHS were similar with RIB + NSAI vs NSAI alone over the NATALEE duration. Thus, adding RIB in the adjuvant setting maintains HRQoL compared with NSAI alone in pts with HR+/HER2− EBC.

Clinical trial identification

NCT03701334; Release date: October 10, 2018.