Treatment Outcomes of Patients with Early-Stage Breast Cancer Meeting NATALEE Eligibility Criteria. A Real-World Cohort Study
- 1Section of Hematology and Medical Oncology, Department of Internal Medicine, King Hussein Cancer Center, Amman, 11941, Jordan
- 2School of Medicine, The University of Jordan, Amman, 11941, Jordan
Abstract
Purpose: Adjuvant CDK4/6 inhibitors have demonstrated significant disease-free survival (DFS) benefits in high-risk early-stage hormone receptor (HR)-positive /HER2-negative breast cancer. However, real-world outcome data describing patients who would meet contemporary eligibility criteria remain limited. This study evaluates treatment outcomes in patients retrospectively classified as eligible for adjuvant ribociclib treatment.
Patients and Methods: A retrospective cohort analysis was conducted using clinical data from patients with early-stage HR-positive/HER2-negative breast cancer. Eligibility for adjuvant ribociclib was assigned using the NATALEE trial-based criteria. Differences in treatment outcomes in those eligible versus ineligible patients are reported.
Results: Among the 2730 patients included, 1,955 (71.6%) were high risk and would have met NATALEE eligibility, including 1,679 (85.9%) with node-positive disease, 602 (30.8%) with cT3-4 tumors, and 686 (35.1%) with grade 3 disease; 775 (28.4%) were ineligible due to lower-risk features. Across the cohort, the 5-year DFS rate was significantly worse in CDK4/6i-eligible patients compared to those deemed ineligible: 78.4% versus 91.5% (HR=2.51; 95% CI: 2.01–3.14; p<0.0001). Though median OS was not reached, survival curve separation became evident by 36 months and widened progressively. Multivariable Cox regression identified low/intermediate ER expression (<50%), node-positive disease, larger tumors (cT3-4), and grade 3 histology as independent predictors of worse overall survival. Low/intermediate ER expression was associated with significantly poorer OS (HR 1.85, 95% CI 1.27–2.70; p=0.001), while lower-grade and smaller tumors were associated with improved survival.
Conclusion: A significant proportion of patients in this real-world cohort would have met criteria for adjuvant CDK4/6 inhibition. These patients experienced worse survival outcomes compared to their ineligible counterparts. These findings provide real-world historical outcome data for patients who would now be considered candidates for adjuvant ribociclib and may serve as a benchmark for evaluating outcomes following adoption of adjuvant ribociclib.
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BibTeX
@article{abdelrazeq2026treatment,
title = {{Treatment Outcomes of Patients with Early-Stage Breast Cancer Meeting NATALEE Eligibility Criteria. A Real-World Cohort Study}},
author = {Hikmat Abdel-Razeq and Malek Horani and Faris Tamimi and Tamer Al-Batsh and Osama El Khatib and Yosra Almasri and Ameed Sameer Ghanem and Qutaiba Jawarneh and Maram Ismat Al-yag’oub and Adel Yousef Jaffal and Rnad Khader and Asala Alanani and Baha Sharaf and Maryam El-Atrash and Tala Abuhamdah and Ayat Taqash},
journal = {Drug Design, Development and Therapy},
year = {2026},
month = oct,
doi = {10.2147/dddt.s637101},
url = {https://doi.org/10.2147/dddt.s637101},
note = {CC BY-NC 4.0},
}
RIS
TY - JOUR
TI - Treatment Outcomes of Patients with Early-Stage Breast Cancer Meeting NATALEE Eligibility Criteria. A Real-World Cohort Study
AU - Hikmat Abdel-Razeq
AU - Malek Horani
AU - Faris Tamimi
AU - Tamer Al-Batsh
AU - Osama El Khatib
AU - Yosra Almasri
AU - Ameed Sameer Ghanem
AU - Qutaiba Jawarneh
AU - Maram Ismat Al-yag’oub
AU - Adel Yousef Jaffal
AU - Rnad Khader
AU - Asala Alanani
AU - Baha Sharaf
AU - Maryam El-Atrash
AU - Tala Abuhamdah
AU - Ayat Taqash
PY - 2026
DA - 2026/10/22
JO - Drug Design, Development and Therapy
DO - 10.2147/dddt.s637101
UR - https://doi.org/10.2147/dddt.s637101
AB - Purpose: Adjuvant CDK4/6 inhibitors have demonstrated significant disease-free survival (DFS) benefits in high-risk early-stage hormone receptor (HR)-positive /HER2-negative breast cancer. However, real-world outcome data describing patients who would meet contemporary eligibility criteria remain limited. This study evaluates treatment outcomes in patients retrospectively classified as eligible for adjuvant ribociclib treatment. Patients and Methods: A retrospective cohort analysis was conducted using clinical data from patients with early-stage HR-positive/HER2-negative breast cancer. Eligibility for adjuvant ribociclib was assigned using the NATALEE trial-based criteria. Differences in treatment outcomes in those eligible versus ineligible patients are reported. Results: Among the 2730 patients included, 1,955 (71.6%) were high risk and would have met NATALEE eligibility, including 1,679 (85.9%) with node-positive disease, 602 (30.8%) with cT3-4 tumors, and 686 (35.1%) with grade 3 disease; 775 (28.4%) were ineligible due to lower-risk features. Across the cohort, the 5-year DFS rate was significantly worse in CDK4/6i-eligible patients compared to those deemed ineligible: 78.4% versus 91.5% (HR=2.51; 95% CI: 2.01–3.14; p<0.0001). Though median OS was not reached, survival curve separation became evident by 36 months and widened progressively. Multivariable Cox regression identified low/intermediate ER expression (<50%), node-positive disease, larger tumors (cT3-4), and grade 3 histology as independent predictors of worse overall survival. Low/intermediate ER expression was associated with significantly poorer OS (HR 1.85, 95% CI 1.27–2.70; p=0.001), while lower-grade and smaller tumors were associated with improved survival. Conclusion: A significant proportion of patients in this real-world cohort would have met criteria for adjuvant CDK4/6 inhibition. These patients experienced worse survival outcomes compared to their ineligible counterparts. These findings provide real-world historical outcome data for patients who would now be considered candidates for adjuvant ribociclib and may serve as a benchmark for evaluating outcomes following adoption of adjuvant ribociclib.
SN - 1177-8881
ER -