Overall Survival with Ribociclib plus Endocrine Therapy in Breast Cancer
Ribociclib combined with letrozole significantly extends progression‑free survival compared with placebo plus letrozole in postmenopausal women with HR‑positive, HER2‑negative advanced breast cancer.
In a randomized, placebo‑controlled phase 3 trial, 668 postmenopausal women with HR‑positive, HER2‑negative recurrent or metastatic breast cancer received either ribociclib (600 mg daily on a 3‑week‑on, 1‑week‑off schedule) plus letrozole (2.5 mg daily) or placebo plus letrozole. The primary endpoint was investigator‑assessed progression‑free survival. Ribociclib plus letrozole produced a hazard ratio of 0.56 (P=3.29×10⁻⁶) for superiority, with a median follow‑up of 15.3 months. The 18‑month progression‑free survival rate was 63.0% versus 42.2% for placebo, and the overall response rate was 52.7% versus 37.1%. Common grade 3/4 adverse events included neutropenia and leukopenia.
The study demonstrates a clinically meaningful improvement in progression‑free survival for patients with first‑line HR‑positive, HER2‑negative advanced breast cancer, establishing ribociclib with letrozole as a new standard of care.
Bizonyítékszint: Irányelv / elfogadott gyakorlat. Magas szintű klinikai elfogadottság.
Kapcsolódó jelek
- 20‑Year Risks of Breast‑Cancer Recurrence after Stopping Endocrine Therapy at 5 Years
- Breast Cancer: The good, the bad, and an important call to effective risk reduction strategies
- Clinical Trials in Cancer - Transforming Clinical Research in the United States - NCBI Bookshelf
- Decoding Clinical Trials in Metastatic Breast Cancer: Practical Insights for Optimal Therapy Sequencing
- The SURVIVE study (NCT05658172): Bringing breast cancer aftercare to the 21st century: Study protocol of a Phase III clinical trial comparing liquid biopsy guided vs. Standard of care surveillance for intermediate to high-risk breast cancer survivors - PMC