Health-Related Quality of Life in Patients with HR+/HER2− Early Breast Cancer Treated with Ribociclib Plus a Nonsteroidal Aromatase Inhibitor: Results from the NATALEE Trial
Journal
Clinical Cancer Research
Series/Report No.
Clinical Cancer Research
Journal Volume
31
Journal Issue
9
Start Page
1625-1635
ISSN
1078-0432
1557-3265
Date Issued
2025-02-28
Author(s)
Fasching, Peter A.
Slamon, Dennis
Nowecki, Zbigniew
Kukielka-Budny, Bozena
Stroyakovskiy, Daniil
Yardley, Denise A.
Chan, Arlene
Chia, Stephen
Martín, Miguel
Rugo, Hope S.
Loi, Sherene
Hurvitz, Sara
Untch, Michael
Afenjar, Karen
Fresco, Rodrigo
Danyliv, Andriy
Ferrusi, Ilia
Li, Zheng
Hortobagyi, Gabriel
Abstract
Purpose: The phase III NATALEE trial reported a statistically significant invasive disease-free survival benefit with ribociclib plus nonsteroidal aromatase inhibitor (NSAI) versus an NSAI alone in stage II/III hormone receptor-positive, HER2-negative (HR+/HER2-) early breast cancer. In this study, we report health-related quality of life (HRQOL) data from NATALEE.
Patients and methods: Patients were randomized to receive ribociclib plus NSAI or NSAI alone. Patient-reported outcome scores [European Organisation for Research and Treatment of Cancer core quality of life questionnaire global health status and physical, social, and emotional functioning domains; the supplementary European Organisation for Research and Treatment of Cancer breast cancer-specific QOL questionnaire breast symptoms scale; health on a visual analog scale of the generic EuroQOL 5-level instrument; and the Hospital Anxiety and Depression Scale] were assessed. The prespecified primary HRQOL endpoint was physical functioning. Mean scores and time-categorical and prespecified linear-time repeated-measure models were used to evaluate HRQOL changes during treatment.
Results: HRQOL was evaluated in all patients in the ribociclib plus NSAI (n = 2,549) and NSAI alone (n = 2,552) arms. Compliance was high in both arms (≈93%-97%). Mean scores did not differ meaningfully from baseline for any analyzed domain. Likewise, neither a meaningful change from baseline (in either treatment arm) nor a difference between arms was observed during treatment in the time-categorical, model-adjusted mean scores for any HRQOL domains-using published thresholds for interpreting longitudinal and between-group differences, with all values being within 0.5 SD of their baseline values. Linear-time regression analysis confirmed these findings.
Conclusions: These analyses of NATALEE show that adding adjuvant ribociclib to an NSAI does not negatively affect HRQOL in patients with HR+/HER2- early breast cancer.
SDGs
Publisher
American Association for Cancer Research (AACR)
Type
journal article