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

Fasching, PA; Slamon, D; Nowecki, Z; Kukielka-Budny, B; Stroyakovskiy, D; Yardley, DA; Huang, CS; Chan, A; Chia, S; Mart&#237;n, M; Rugo, HS; Loi, S; Hurvitz, S; Untch, M; Afenjar, K; Fresco, R; Danyliv, A; Ferrusi, I; Li, Z; Hortobagyi, G

Author(s): Fasching, PA; Slamon, D; Nowecki, Z; Kukielka-Budny, B; Stroyakovskiy, D; Yardley, DA; Huang, CS; Chan, A; Chia, S; Martín, M; Rugo, HS; Loi, S; Hurvitz, S; Untch, M; Afenjar, K; Fresco, R; Danyliv, A; Ferrusi, I; Li, Z; Hortobagyi, G;
Details: Publication Year 2025-05-01,Volume 31,Issue #9,Page 1625-1635
Journal Title: Clinical Cancer Research
Publication Type: Research article
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.
Publisher: American Association for Cancer Research
Keywords: Adult; Aged; Female; Humans; Middle Aged; Aminopyridines/administration & dosage; *Antineoplastic Combined Chemotherapy Protocols/therapeutic use/adverse effects; Aromatase Inhibitors/administration & dosage; *Breast Neoplasms/drug therapy/pathology/genetics/metabolism; Neoplasm Staging; Patient Reported Outcome Measures; Purines/administration & dosage; *Quality of Life; Receptor, ErbB-2/metabolism/genetics; Receptors, Estrogen/metabolism; Receptors, Progesterone/metabolism; Treatment Outcome
Department(s): Medical Oncology
Publisher's Version: https://doi.org/10.1158/1078-0432.Ccr-24-1724
Open Access at Publisher's Site: https://doi.org/10.1158/1078-0432.Ccr-24-1724
Terms of Use/Rights Notice: Refer to copyright notice on published article.

Creation Date: 2025-03-18 06:23:40

Last Modified: 2025-06-02 01:58:39