The Clinical Relevance of the NATALEE Study: Application of the NATALEE Criteria to a Real-World Cohort from Two Large German Breast Cancer Centers
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Published:2023-11-15
Issue:22
Volume:24
Page:16366
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ISSN:1422-0067
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Container-title:International Journal of Molecular Sciences
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language:en
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Short-container-title:IJMS
Author:
Schäffler Henning1, Mergel Franziska1, Pfister Kerstin1, Lukac Stephan1, Fink Angelina1, Veselinovic Kristina1, Rack Brigitte1, Fink Visnja1, Leinert Elena1, Dimpfl Moritz2, Englisch Alexander3, Tegeler Christian Martin3ORCID, Seller Anna3, Grischke Eva-Maria3, Hahn Markus3, Volmer Léa Louise3, Engler Tobias3ORCID, Frevert Marie Louise4, Taran Florin Andrei4ORCID, Janni Wolfgang1, Brucker Sara Yvonne3ORCID, Hartkopf Andreas Daniel13ORCID, Dannehl Dominik3ORCID
Affiliation:
1. Department of Gynecology and Obstetrics, University Hospital Ulm, 89075 Ulm, Germany 2. Department of Gynecology and Obstetrics, University Hospital Mannheim, 68135 Mannheim, Germany 3. Department of Women’s Health, Tuebingen University, 72076 Tuebingen, Germany 4. Department of Obstetrics and Gynecology, University of Freiburg, 79106 Freiburg, Germany
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.
Subject
Inorganic Chemistry,Organic Chemistry,Physical and Theoretical Chemistry,Computer Science Applications,Spectroscopy,Molecular Biology,General Medicine,Catalysis
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