The Clinical Relevance of the NATALEE Study: Application of the NATALEE Criteria to a Real-World Cohort from Two Large German Breast Cancer Centers

Abstract

The NATALEE study showed a significant benefit in invasive disease-free survival (iDFS) for patients with HR+/HER2− early breast cancer (eBC) at intermediate and high risk of recurrence who were treated with the CDK4/6 inhibitor Ribociclib in combination with endocrine therapy (ET). This retrospective study aims to apply the NATALEE inclusion criteria to a representative real-world cohort to estimate the proportion of HR+/HER2− breast cancer patients eligible for adjuvant Ribociclib therapy. Patients who underwent full surgical treatment for eBC between January 2018 and December 2020 at two large German university breast cancer centers (University of Ulm, University of Tuebingen) were included. Descriptive statistics were used to characterize the patient population eligible for Ribociclib treatment based on the NATALEE study’s inclusion criteria. Out of 2384 enrolled patients, 1738 had HR+/HER2− eBC, of whom 43% (747/1738) met the NATALEE inclusion criteria. Of note, these patients were older, received less chemotherapy and presented with less advanced tumor stages compared to the NATALEE study cohort. Additionally, compared to the NATALEE study cohort, fewer patients had lymph node involvement (72.4% vs. 88.7%). Our analysis suggests that approximately 43% of all HR+/HER2− breast cancer patients will qualify for Ribociclib treatment. Given the numerous treatment options for patients with HR+/HER2− eBC, as well as the differences between the NATALEE cohort and patients in the real-world clinical setting, future analyses will be needed to determine which patients would benefit most from adjuvant CDK4/6 inhibitor treatment.

Implementation and Evaluation of a Breast Cancer Disease Model Using Real-World Claims Data in Germany from 2010 to 2020

“…Overall, the estimated tumor subtype in this analysis closely matched those reported in the current literature. However, in our analysis, the proportion of triple-negative breast cancer was higher, while the proportion of HR+ and HER2+ breast cancer was lower when compared to real-world data [6,7,10]. This observation can be explained by primary nonadherence to endocrine therapy and HER2-targeted therapy since patients might be refraining from filling the prescription for endocrine therapy at the pharmacy or have refused to undergo systemic therapy from the beginning [37].…”

“…To characterize the clinical and epidemiological components of breast cancer in a realworld setting, different data sources can be utilized: retrospective reviews of clinical cases, retrospective state-wide, national, or international cancer registries, prospective clinical trials, and prospective clinical registries [5][6][7][8][9][10]. However, retrospective claims data analysis has emerged as an important tool to further elucidate patient characteristics, comorbidities, treatment algorithms, and clinical outcomes [11][12][13].…”