Ribociclib Plus Endocrine Therapy in Hormone Receptor‑Positive/ERBB2‑Negative Early Breast Cancer: 4‑Year Outcomes From the NATALEE Randomized Clinical Trial
In a 4‑year exploratory analysis of the NATALEE phase‑3 trial, ribociclib combined with a non‑steroidal aromatase inhibitor (NSAI) significantly improved invasive disease‑free survival (iDFS) and distant disease‑free survival (DDFS) compared with NSAI alone, reducing recurrence risk by 28.5 % and increasing the absolute iDFS benefit from 3 to 4 years.
The NATALEE trial evaluated the addition of 3 years of ribociclib to standard adjuvant NSAI in 5 101 patients with stage II/III hormone‑receptor positive/ERBB2‑negative early breast cancer. In a 4‑year exploratory analysis, ribociclib plus NSAI demonstrated a hazard ratio of 0.72 for iDFS versus NSAI alone, producing a 28.5 % relative reduction in recurrence and an absolute increase in 4‑year iDFS rates from 83.6 % (NSAI alone) to 88.5 % (ribociclib+NSAI). The benefit was consistent across clinical subgroups, and the incidence of adverse events remained stable. Overall survival data were immature but trended favorably.
This study confirms that extending adjuvant ribociclib beyond the planned 3‑year period continues to reduce recurrence risk in high‑risk hormone‑receptor positive/ERBB2‑negative breast cancer, informing clinicians and patients on long‑term therapeutic benefits and influencing future guidelines on adjuvant CDK4/6 inhibitor use.
Evidence level: Sejtvonalas. Laboratóriumi sejtekben vizsgálták.
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