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. 2025 Jun 3;31(11):2222-2229.
doi: 10.1158/1078-0432.CCR-24-3836.

Identification of Early-Stage Breast Cancer with a Minimal Risk of Recurrence by the Breast Cancer Index

Marie-France Jilderda  1 , Yi Zhang  2 , Valerie Rebattu  1 , Ranelle Salunga  2 , Wilma Mesker  1 , Jenna Wong  2 , Linda de Munck  3 , Tommy Fornander  4 , Bo Nordenskjöld  5 , Olle Stål  5 , Amanda K L Anderson  2 , Esther Bastiaannet  6 , Kai Treuner  2 , Gerrit-Jan Liefers  1
Affiliations

Identification of Early-Stage Breast Cancer with a Minimal Risk of Recurrence by the Breast Cancer Index

Marie-France Jilderda et al. Clin Cancer Res. .

Abstract

Purpose: This study assessed the prognostic ability of the breast cancer index (BCI) to identify patients at a minimal risk (<5%) of 10-year distant recurrence (DR) who are unlikely to benefit from adjuvant endocrine therapy.

Experimental design: This prospective translational study included postmenopausal patients with early-stage, hormone receptor-positive N0 breast cancer from the Stockholm (STO-3) trial who underwent surgery alone ("untreated") or surgery plus adjuvant tamoxifen ("treated") and from the Netherlands Cancer Registry (surgery alone). The primary endpoint was time to DR. An adjusted BCI model with an additional cutpoint was developed, which stratified patients into four prognostic risk groups.

Results: Across cohorts, 16% to 22% of patients were classified as minimal risk of 10-year DR. In the Stockholm untreated cohort (n = 283), risks in the minimal-, low-, intermediate-, and high-risk groups were 2.3%, 15.5% [hazard ratio, 4.71 (95% confidence interval, 1.09-20.29) vs. minimal risk], 19.8% [6.97 (1.61-30.18)], and 35.9% [13.21 (3.07-56.76)], respectively (P < 0.001). In the Stockholm treated cohort (n = 317), risks were 4.3%, 5.0% [1.16 (0.35-3.85)], 11.7% [2.45 (0.74-8.14)], and 21.1% [5.27 (1.72-16.16); P < 0.001]. In the Netherlands Cancer Registry cohort (n = 1245), risks were 4.5%, 7.5% [subdistribution hazard ratio, 1.67 (95% confidence interval, 0.81-3.45)], 10.3% [2.40 (1.14-5.03)], and 13.1% [3.13 (1.50-6.55); P = 0.005]. BCI risk scores provided additional independent information over standard prognostic factors (likelihood ratio, χ2 = 7.98; P = 0.004).

Conclusions: The adjusted BCI model identified women with early-stage, hormone receptor-positive N0 breast cancer at a minimal risk of DR who may consider de-escalating adjuvant endocrine therapy.

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Conflict of interest statement

M. F. Jilderda reports grants from Hologic/Biotheranostics during the conduct of the study. Y. Zhang reports a patent for the biomarker analyzed in this work pending and issued. V. Rebattu reports grants from Hologic/Biotheranostics during the conduct of the study. O. Stål reports grants from The Swedish Cancer Society outside the submitted work. A.K.L. Anderson reports other support from Hologic outside the submitted work. K. Treuner reports a patent for BCI pending. G.-J. Liefers reports other support from Hologic during the conduct of the study. No disclosures were reported by the other authors.

Figures

Figure 1.
Figure 1.
CONSORT diagram for patient selection in the NCR cohort.
Figure 2.
Figure 2.
Performance of the adjusted BCI model in the Stockholm cohorts. The new cutpoint for the BCI minimal-risk group was trained using the untreated patients. (A) Untreated and (B) TAM-treated. TAM, tamoxifen.
Figure 3.
Figure 3.
Performance of the adjusted BCI model in the NCR cohort (A) overall and (B–D) in clinical subsets. G2/G3, grade 2/3; T1/T2, T stage 1/2.
See this image and copyright information in PMC

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