Ribociclib plus Endocrine Therapy in Early Breast Cancer
- Author(s)
- Slamon, D; Lipatov, O; Nowecki, Z; McAndrew, N; Kukielka-Budny, B; Stroyakovskiy, D; Yardley, DA; Huang, CS; Fasching, PA; Crown, J; Bardia, A; Chia, S; Im, SA; Ruiz-Borrego, M; Loi, S; Xu, B; Hurvitz, S; Barrios, C; Untch, M; Moroose, R; Visco, F; Afenjar, K; Fresco, R; Severin, I; Ji, Y; Ghaznawi, F; Li, Z; Zarate, JP; Chakravartty, A; Taran, T; Hortobagyi, G;
- Details
- Publication Year 2024-03-21,Volume 390,Issue #12,Page 1080-1091
- Journal Title
- New England Journal of Medicine
- Publication Type
- Research article
- Abstract
- BACKGROUND: Ribociclib has been shown to have a significant overall survival benefit in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer. Whether this benefit in advanced breast cancer extends to early breast cancer is unclear. METHODS: In this international, open-label, randomized, phase 3 trial, we randomly assigned patients with HR-positive, HER2-negative early breast cancer in a 1:1 ratio to receive ribociclib (at a dose of 400 mg per day for 3 weeks, followed by 1 week off, for 3 years) plus a nonsteroidal aromatase inhibitor (NSAI; letrozole at a dose of 2.5 mg per day or anastrozole at a dose of 1 mg per day for ≥5 years) or an NSAI alone. Premenopausal women and men also received goserelin every 28 days. Eligible patients had anatomical stage II or III breast cancer. Here we report the results of a prespecified interim analysis of invasive disease-free survival, the primary end point; other efficacy and safety results are also reported. Invasive disease-free survival was evaluated with the use of the Kaplan-Meier method. The statistical comparison was made with the use of a stratified log-rank test, with a protocol-specified stopping boundary of a one-sided P-value threshold of 0.0128 for superior efficacy. RESULTS: As of the data-cutoff date for this prespecified interim analysis (January 11, 2023), a total of 426 patients had had invasive disease, recurrence, or death. A significant invasive disease-free survival benefit was seen with ribociclib plus an NSAI as compared with an NSAI alone. At 3 years, invasive disease-free survival was 90.4% with ribociclib plus an NSAI and 87.1% with an NSAI alone (hazard ratio for invasive disease, recurrence, or death, 0.75; 95% confidence interval, 0.62 to 0.91; P = 0.003). Secondary end points - distant disease-free survival and recurrence-free survival - also favored ribociclib plus an NSAI. The 3-year regimen of ribociclib at a 400-mg starting dose plus an NSAI was not associated with any new safety signals. CONCLUSIONS: Ribociclib plus an NSAI significantly improved invasive disease-free survival among patients with HR-positive, HER2-negative stage II or III early breast cancer. (Funded by Novartis; NATALEE ClinicalTrials.gov number, NCT03701334.).
- Publisher
- Massachusetts Medical Society
- Keywords
- Female; Humans; Aminopyridines/administration & dosage/adverse effects/therapeutic use; *Antineoplastic Combined Chemotherapy Protocols/administration & dosage/adverse; effects/therapeutic use; *Breast Neoplasms/drug therapy/metabolism/mortality/pathology; *Letrozole/administration & dosage/adverse effects/therapeutic use; Purines/administration & dosage/adverse effects/therapeutic use; Receptor, ErbB-2/metabolism; *Aromatase Inhibitors/administration & dosage/adverse effects/therapeutic use; Receptors, Estrogen; Receptors, Progesterone; Goserelin/administration & dosage/adverse effects/therapeutic use; Antineoplastic Agents, Hormonal; Male
- Department(s)
- Medical Oncology
- Publisher's Version
- https://doi.org/10.1056/NEJMoa2305488
- Terms of Use/Rights Notice
- Refer to copyright notice on published article.
Creation Date: 2024-04-18 04:53:26
Last Modified: 2024-04-18 05:10:25