22 Efficacy and Safety of Ribociclib + Nonsteroidal Aromatase Inhibitor in Younger Patients With HR+/HER2− Early Breast Cancer in NATALEE

Publication
Article
Miami Breast Cancer Conference® Abstracts Supplement42nd Annual Miami Breast Cancer Conference® - Abstracts
Volume 39
Issue 4
Pages: 13-14

22 Efficacy and Safety of Ribociclib + Nonsteroidal Aromatase Inhibitor in Younger Patients With HR+/HER2− Early Breast Cancer in NATALEE

22 Efficacy and Safety of Ribociclib + Nonsteroidal Aromatase Inhibitor in Younger Patients With HR+/HER2− Early Breast Cancer in NATALEE

Background

NATALEE showed a statistically significant invasive disease-free survival (iDFS) benefit of ribociclib plus nonsteroidal aromatase inhibitor (NSAI) vs NSAI (HR, 0.749; 95% CI, 0.628-0.892; P = .0006) in patients with hormone receptor–positive (HR+)/HER2-negative (HER2–) early breast cancer (EBC). We report ribociclib efficacy/safety in patients < 40 vs ≥ 40 years in NATALEE.

Materials and Methods

Patients were treated with ribociclib plus NSAI or NSAI alone. Premenopausal patients received goserelin. Efficacy/safety/patient-reported outcomes were assessed (data cutoff: July 21, 2023; median follow-up, 36.7 months).

Results

Of 5101 patients, 543 (10.6% ribociclib plus NSAI) were
< 40 years (93.9% premenopausal), with 4558 (89.4% ribociclib plus NSAI) ≥ 40 years (38.2% premenopausal). Patients < 40 years were generally at higher risk prior to surgery vs patients ≥ 40 years (neoadjuvant chemotherapy, 61.1% vs 40.5%; G3, 26.5% vs 20.3%; N1-3, 70.0% vs 58.5%). Ribociclib plus NSAI showed iDFS benefit (< 40 years, HR 0.546; 95% CI, 0.321-0.929; ≥ 40 years, HR 0.780; 95% CI, 0.648-0.939), with similar trends for distant recurrence-free, recurrence-free, and distant disease-free survival. 3-year iDFS rates were higher in patients on ribociclib plus NSAI vs NSAI alone among patients < 40 years (90.1% vs 85.0%) and ≥ 40 years (90.7% vs 87.9%). Adverse effect (AE) rates and ribociclib dose reductions/discontinuations are presented in the Table. Global health status and physical functioning scores showed no evidence of difference between arms in patients aged < 40 or ≥ 40 years.

Table. Safety Assessed in the NATALEE Trial

Table. Safety Assessed in the NATALEE Trial

Conclusion

Adjuvant ribociclib plus NSAI showed treatment benefit in patients with HR+/HER2− EBC, including in patients < 40 years, who had more aggressive disease than patients ≥ 40 years. Safety profiles were consistent between age groups, but patients < 40 years were less likely to discontinue ribociclib due to AEs with or without prior dose reduction.

Articles in this issue

2 Preventive Care and Screening Adherence Among Women Surviving Breast Cancer
2 Preventive Care and Screening Adherence Among Women Surviving Breast Cancer
3 Intraoperative Radiotherapy: Alive and Well in the Bronx
3 Intraoperative Radiotherapy: Alive and Well in the Bronx
4 Evaluating AI-Driven Responses in Breast Reconstruction: A Comparative Study of Response Formats
4 Evaluating AI-Driven Responses in Breast Reconstruction: A Comparative Study of Response Formats
5 Correlation Between Visual Impairment and Breast Cancer: A Cross-Sectional Study Based on the National Health Interview Surveys
5 Correlation Between Visual Impairment and Breast Cancer: A Cross-Sectional Study Based on the National Health Interview Surveys
6 Peer Support Programming Among Women At-Risk for Surviving Breast Cancer: Facilitators and Barriers to Community-Based Patient Navigation and the Role of Quality of Life
6 Peer Support Programming Among Women At-Risk for Surviving Breast Cancer: Facilitators and Barriers to Community-Based Patient Navigation and the Role of Quality of Life
7 Metaplastic Breast Cancer: A Retrospective Chart Review of Clinical Features
7 Metaplastic Breast Cancer: A Retrospective Chart Review of Clinical Features
8 A Case Series Exploring Characteristics and Outcomes of Metachronous Primary Breast and Lung Cancer in a Diverse Cohort
8 A Case Series Exploring Characteristics and Outcomes of Metachronous Primary Breast and Lung Cancer in a Diverse Cohort
9 Body Mass Index, Cancer Risk Behaviors, and Readiness for Dietary Change Among Women Surviving With Breast Cancer
9 Body Mass Index, Cancer Risk Behaviors, and Readiness for Dietary Change Among Women Surviving With Breast Cancer
10 AI as a Bridge: Can ChatGPT Help Patients Understand Their Breast Radiology Reports?
10 AI as a Bridge: Can ChatGPT Help Patients Understand Their Breast Radiology Reports?
12 Gut Microbiome Composition and Pathological Complete Response After Chemotherapy in Breast Cancer: Insights From a Pilot Study
12 Gut Microbiome Composition and Pathological Complete Response After Chemotherapy in Breast Cancer: Insights From a Pilot Study
13 Preliminary Analysis of Change During Treatment of Financial Toxicity and Quality of Life in Breast Cancer Patients
13 Preliminary Analysis of Change During Treatment of Financial Toxicity and Quality of Life in Breast Cancer Patients
15 Utilizing Circulating Tumor Cells to Guide HER2-Directed Therapy in IHC/FISH-Negative HER2+ Metastatic Breast Cancer
15 Utilizing Circulating Tumor Cells to Guide HER2-Directed Therapy in IHC/FISH-Negative HER2+ Metastatic Breast Cancer
16 A Miami Hospital’s Infrastructure to Help Decrease Late-Stage Breast Cancer Diagnosis and Improve Health Equity
16 A Miami Hospital’s Infrastructure to Help Decrease Late-Stage Breast Cancer Diagnosis and Improve Health Equity
17 Salmonella and the Breast: A Literature Review of Salmonella-Induced Breast Abscesses
17 Salmonella and the Breast: A Literature Review of Salmonella-Induced Breast Abscesses
18 Tolerability of First-Line Treatment With Ribociclib for Metastatic Breast Cancer Using 2 Large US Data Sources
18 Tolerability of First-Line Treatment With Ribociclib for Metastatic Breast Cancer Using 2 Large US Data Sources
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