ASCO
ASCO 2024: Ribociclib plus endocrine therapy reduces recurrence risk in early breast cancer
New data from the phase 3 NATALEE trial showed that ribociclib (RIB) plus endocrine therapy (ET), compared with ET alone, led to improved rates of invasive disease-free survival (iDFS), distant recurrence-free survival (DRFS), and distant disease-free survival (DDFS) in high-risk early breast cancer (EBC) patients with node-negative (N0) disease.
- Patients with stage II/III HR+/HER2− EBC were randomized 1:1 to RIB 400 mg/day (3 wk on/1 wk off for 36 mo) + non-steroidal aromatase inhibitor (NSAI; letrozole or anastrozole for ≥60 mo) or NSAI alone.
- Of 2,549 pts randomized to RIB + NSAI and 2,552 to NSAI alone, 285 (11%) and 328 (13%) had N0 disease, respectively. Patients could receive any standard (neo)adjuvant ET ≤12 mo before randomization. In the intent-to-treat (ITT) population, 78% of pts completed 3 years of RIB treatment or discontinued early with 21% still on treatment at the time of this analysis. The N0 subgroup included patients with T2N0, T3N0, and T4N0 (stage IIIB); T1N0 was excluded.
- Consistent with the ITT population, RIB + NSAI improved iDFS, DDFS, and DRFS in patients with high-risk N0 disease.
- The safety profile of RIB in the N0 subgroup was consistent with the ITT population. The rate of discontinuation due to all grade adverse events was 24% vs. 8% with RIB + NSAI vs NSAI alone.
- The findings support the use of RIB in patients with HR+/HER2− EBC at increased risk of recurrence, including those with N0 disease.
Source:
Yardley, D., et al. Baseline (BL) characteristics and efficacy endpoints for patients (pts) with node-negative (N0) HR+/HER2- early breast cancer (EBC): NATALEE trial. Abstract #512. Presented at: 2024 ASCO Annual Meeting; May 31 – June 4. Chicago, IL. https://meetings.asco.org/abstracts-presentations/233536