Clinical Treatment Score Post-5 Years (CTS5) and Late Recurrence Risk in Hormone Receptor–Positive, HER2-Positive Breast Cancer
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UPMC Hillman Cancer Center, University of Pittsburgh School of Medicine, Pittsburgh, PA
UPMC Magee-Women’s Hospital, Pittsburgh, PA
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Background: The Clinical Treatment Score post-5 years (CTS5) is a risk stratification tool used to determine the risk of late recurrence in hormone receptor–positive (HR+), HER2-negative breast cancer (BC). Limited data exist on its use in HR+, HER2-positive (HER2+) BC. Patients and Methods: CTS5 was evaluated in HR+, HER2+ BC in the North Central Cancer Treatment Group (NCCTG) N9831 (Alliance) and NSABP B-31 (NRG) trials. Results: A total of 1,862 patients with HR+, HER2+ BC without recurrence 5 years after enrollment were included. Overall, the CTS5 score was significantly associated with recurrence-free survival (RFS), with a hazard ratio (HR) of 1.35 (95% CI, 1.12–1.63; P=.002), but did not reach statistical significance in patients who received trastuzumab (n=829; HR, 1.29; 95% CI, 0.98–1.71; P=.07). CTS5 risk category was not significantly associated with RFS. In patients who received trastuzumab, other variables used in CTS5, including patient age and tumor size, were not significantly associated with RFS. N3 was significantly associated with worse outcomes (HR, 1.86; 95% CI, 1.09–3.17; P=.02) compared with N0–N1. Paradoxically, higher tumor grade was associated with better outcomes after 5 years in the multivariate analysis (HR, 0.71; 95% CI, 0.50–1.00; P=.05). The incidence of recurrences or deaths between years 5 to 10 was 10.6% in the CTS5 low-risk category, 5.6% in the intermediate-risk category, and 9.8% in the high-risk category. Conclusions: The CTS5 model does not accurately predict the risk of late recurrence in HR+, HER2+ BC treated with adjuvant trastuzumab in the N9831 and B-31 trials. This study underlines the need to develop a new prognostic model to better delineate the risk of late recurrence in patients with HR+, HER2+ BC receiving adjuvant trastuzumab.
ClinicalTrials.gov identifiers: NCT00005970 (NCCTG N9831) and NCT00004067 (NRG/NSABP B-31).
Submitted August 21, 2023; final revision received December 24, 2023; accepted for publication February 1, 2024. Published online August 26, 2024.
Previous presentation: Data included in this manuscript were presented at the 2021 San Antonio Breast Cancer Symposium; December 7–10, 2021; San Antonio, Texas. Abstract PS6-03.
Author contributions: Conceptualization: Chumsri. Data curation: Pai, Gil. Formal analysis: Chumsri, Ma, Li. Funding acquisition: Thompson. Investigation: Chumsri. Supervision: Moreno-Aspitia, Colon-Otero, Pogue-Geile, Rasgoti, Paik, Perez, Thompson. Writing—original draft: Chumsri. Writing—review & editing: Chumsri, Pai, Ma, Li, Moreno-Aspitia, Colon-Otero, Pogue-Geile, Rasgoti, Paik, Perez, Thompson.
Disclosures: Dr. Chumsri has disclosed receiving grant/research support from and serving as a principal investigator for Merck & Co., Inc., Pfizer Inc., Salix Pharmaceuticals, Rebiotix Inc., Novartis, and BriaCell Therapeutics; serving as a scientific advisor for AstraZeneca, Daiichi Sankyo, Immunomedics, BioTheranostics, Novartis, Athenex, Syndax Pharmaceuticals, Puma Biotechnology, Eisai, and Seagen; and serving as a consultant for Axiom, Cardinal Health, CEPTON Strategies, Eradigm Consulting, Equinox Group, and Novartis. The remaining authors have disclosed that they have not received any financial consideration from any person or organization to support the preparation, analysis, results, or discussion of this article.
Funding: Research reported in this publication was supported by the National Cancer Institute of the National Institutes of Health under award numbers U10CA180821, U24CA196171 (to the Alliance for Clinical Trials in Oncology), UG1CA232760, U10CA180868, UG1CA189867, U10CA180822, and U24CA196067 (to NRG Oncology). This work was also supported in part by funds from the Breast Cancer Research Foundation and Susan G. Komen Foundation.
Disclaimer: The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Supplementary material: Supplementary material associated with this article is available online at https://doi.org/10.6004/jnccn.2024.7015. The supplementary material has been supplied by the author(s) and appears in its originally submitted form. It has not been edited or vetted by JNCCN. All contents and opinions are solely those of the author. Any comments or questions related to the supplementary materials should be directed to the corresponding author.
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