J. Wong (San Diego, CA, United States of America)
Biotheranostics, Inc.Author Of 1 Presentation
- G. Liefers (Leiden, Netherlands)
- I. Noordhoek (Leiden, Netherlands)
- Y. Zhang (San Diego, CA, United States of America)
- D. Sgroi (Boston, MA, United States of America)
- H. Putter (Leiden, Netherlands)
- K. Treuner (San Diego, CA, United States of America)
- J. Wong (San Diego, CA, United States of America)
- E. Meershoek-Klein Kranenbarg (Leiden, Netherlands)
- M. Duijm-De Carpentier (Leiden, Netherlands)
- C. Van de Velde (Leiden, Netherlands)
- C. Schnabel (San Diego, CA, United States of America)
7P - An optimized Breast Cancer Index node-positive (BCIN+) prognostic model for late distant recurrence in patients with hormone receptor-positive (HR+) node-positive breast cancer
Abstract
Background
BCI is a gene expression-based assay that reports a prognostic BCI score that significantly predicts risk of overall (10y), early (0-5y), and late (≥5y) distant recurrence (DR) in HR+, node-negative (N0) and node-positive (N1) breast cancer. The BCIN+ prognostic model was trained in the Trans-ATAC cohort, which evaluated primary adjuvant anastrozole versus tamoxifen. The current study optimized the BCIN+ prognostic model for late DR in N+ patients from the arm treated with 7.5 years of endocrine therapy in the translational cohort of the IDEAL trial.
Methods
Patients with 1 to 3 positive nodes (N1) in the 7.5-year endocrine treatment arm of the translational IDEAL cohort were used to examine cut-points for BCIN+ model across the range of 1 to 9 to classify patients into Low- and High-risk groups. Kaplan-Meier analysis was used to calculate the 15-year (post-diagnosis, 10-year post-randomization) late DR free interval (DRFI) as the primary endpoint. The cut-point was selected based on the classification of a low-risk group with <5% 15-year late DRFI. Initial validation of the optimized prognostic model was performed in a single institution retrospective cohort using Cox proportional hazards regression.
Results
241 N1 IDEAL patients (85% ≥ 55 y, 54% T1, 52% G2) were included. Evaluation of the BCIN+ prognostic model led to an adjusted cut-point, which classified 44 patients as BCIN+ Low Risk with a 15-year late DRFI of 3.2%, and 197 patients as BCIN+ High Risk with a DRFI of 19.0% (HR: 7.11, 95% CI: 0.97-52.17; p=0.024). Independent validation in a retrospective cohort of 349 patients (64% ≥55 y, 66% T1, 58% G2) showed that the optimized BCIN+ model was significantly prognostic for late DR (HR: 9.25, 95% CI: 1.27-67.45; p=0.007), and classified 66 and 283 patients as BCI Low- and High-risk with 1.6% and 15.2% 15-year late DRFI, respectively.
Conclusions
An optimized BCIN+ prognostic model was determined from patients in the randomized IDEAL trial, which was significantly prognostic for late DR in HR+ N1 patients. Additional studies in randomized N+ cohorts are required for further validation of this BCIN+ model optimized for late DR.
Clinical trial identification
BOOG 2006-05.
Legal entity responsible for the study
Biotheranostics, Inc.
Funding
Biotheranostics Inc.; Leiden University Medical Center Institutional Grant; Novartis.
Disclosure
G-J. Liefers: Advisory/Consultancy, Research grant/Funding (institution): Biotheranostics, Inc. Y. Zhang: Travel/Accommodation/Expenses, Shareholder/Stockholder/Stock options, Licensing/Royalties, Full/Part-time employment: Biotheranostics, Inc. D.C. Sgroi: Advisory/Consultancy: Merrimack Pharmaceuticals; Licensing/Royalties: Biotheranostics, Inc. K. Treuner: Travel/Accommodation/Expenses, Shareholder/Stockholder/Stock options, Licensing/Royalties, Full/Part-time employment: Biotheranostics, Inc. J. Wong: Travel/Accommodation/Expenses, Shareholder/Stockholder/Stock options, Full/Part-time employment: Biotheranostics, Inc. C.A. Schnabel: Leadership role, Travel/Accommodation/Expenses, Shareholder/Stockholder/Stock options, Licensing/Royalties, Full/Part-time employment, Officer/Board of Directors: Biotheranostics, Inc. All other authors have declared no conflicts of interest.