ESMO 2024: 4-Year NATALEE Outcomes Support Ribociclib-Based Therapy in Early Breast Cancer

By: Joshua D. Madera, MD
Posted: Friday, September 27, 2024

The 4-year analysis from the phase III NATALEE trial supports the addition of ribociclib to a nonsteroidal aromatase inhibitor (NSAI) in hormone receptor (HR)-positive, HER2-negative, early-stage breast cancer. Based on the findings presented at the European Society for Medical Oncology (ESMO) Congress 2024 (Abstract LBA13), Peter A. Fasching, MD, of the University Hospital Erlangen and Comprehensive Cancer Center, Germany, and colleagues reported that including the CDK4/6 inhibitor in the regimen reduced the risk of recurrence in this patient population.

Patients with HR-positive, HER2-negative, early-stage breast cancer were recruited for the study. All patients were stratified based on nodal status and disease stage. Premenopausal women and men received treatment with goserelin. Patients were randomly assigned to receive treatment with ribociclib plus an NSAI or an NSAI alone.

The study authors reported a significantly improved invasive disease–free survival rate with the addition of ribociclib vs the NSAI alone (hazard ratio [HR] = 0.715). The invasive disease–free survival rates were 90.8% and 88.1% at the 3-year interval and 88.5% and 83.6% at the 4-year interval, respectively. The improved invasive disease–free survival rate was noted regardless of nodal status or disease stage. Furthermore, combined treatment with ribociclib plus an NSAI improved distant disease–free survival compared with an NSAI alone (HR = 0.715). Moreover, trends in predicted overall survival seem to favor the addition of ribociclib, but overall survival data remain immature.

Disclosure: For full disclosures of the study authors, visit cslide.ctimeetingtech.com.

ESMO Congress 2024

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