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Mini Oral session: Breast cancer, early stage

138MO - Prognostic performance of Breast Cancer Index (BCI) in postmenopausal women with early-stage HR+ breast cancer in the TEAM trial

Date

12 Sep 2022

Session

Mini Oral session: Breast cancer, early stage

Topics

Clinical Research;  Endocrine Therapy

Tumour Site

Breast Cancer

Presenters

John Bartlett

Citation

Annals of Oncology (2022) 33 (suppl_7): S55-S84. 10.1016/annonc/annonc1038

Authors

J.M. Bartlett1, K. Xu2, J. Wong3, G. Pond4, Y. Zhang3, M. Spears1, R. Salunga3, E. Mallon5, K.J. Taylor6, A. Hasenburg7, C. Markopoulos8, L.Y. Dirix9, C. Seynaeve10, C. van de Velde11, D. Rea12, C.A. Schnabel3, K. Treuner3, J. Bayani2

Author affiliations

  • 1 Diagnostic Development, Ontario Institute for Cancer Research, M5G 0A3 - Toronto/CA
  • 2 Diagnostics Development, Ontario Institute for Cancer Research, M5G 0A3 - Toronto/CA
  • 3 Diagnostics Oncology Research & Development, Biotheranostics, A Hologic Company, 92121 - San Diego/US
  • 4 Biostatistics, McMaster University Medical Centre - Hamilton Health Sciences, L8N 3Z5 - Hamilton/CA
  • 5 Institute Of Cancer Sciences, University of Glasgow, G12 OZD - Glasgow/GB
  • 6 Institute Of Genetics And Cancer, Cancer Research UK Edinburgh Centre, EH4 2XR - Edinburgh/GB
  • 7 Gynecology And Obstetrics, University Center Mainz, 55131 - Mainz/DE
  • 8 Division Of Breast Surgery, National and Kapodistrian University of Athens, 157 84 - Athens/GR
  • 9 Translational Cancer Research Unit, Sint-Augustinus Cancer Center, 2610 - Wilrijk-Antwerp/BE
  • 10 Medical Oncology, Erasmus MC Cancer Institute, 3015 GD - Rotterdam/NL
  • 11 Surgical Oncology, Leiden University Medical Center, Amsterdam/NL
  • 12 Cancer Research Uk Clinical Trials Unit, University of Birmingham, B15 2SY - Birmingham/GB
More

Resources

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Abstract 138MO

Background

Early-stage HR+ breast cancer patients face a prolonged risk of recurrence even after adjuvant endocrine therapy. The Breast Cancer Index (BCI) and BCIN+ prognostic models are significantly prognostic for risk of overall (0-10y) and late (5-10y) distant recurrence (DR) in N0 and N1 breast cancer, respectively. Here, the prognostic performance of BCI and BCIN+ was evaluated in a cohort of HR+ postmenopausal women from the Tamoxifen and Exemestane Adjuvant Multinational (TEAM) trial.

Methods

BCI testing was performed blinded to clinical outcome with BCI/BCIN+ risk groups calculated based on pre-specified cut-points. Kaplan-Meier analysis and log-rank test were used to assess the prognostic significance of BCI/BCIN+ risk groups based on DR. Cox proportional hazard models with and without clinical covariates were used to estimate hazard ratios (HRs) and the associated 95% confidence intervals (CIs).

Results

1520 HR+ N0 and 2249 N1 patients were included. For overall 10y DR, BCI stratified 1197 N0 patients who did not receive chemotherapy into three prognostic groups: 47% low-, 29% intermediate- and 24% high-risk. BCIN+ stratified 1319 N1 patients into two groups: 23% low- and 77% high-risk. In the 3053 patients who were DR-free for 5 years, the 10-year late DR rates for low- and high-risk were 5.4% (95%CI: 3.0%-7.8%) and 9.3% (95%CI: 6.7%-11.8%) in the N0 cohort (N= 1285) and 5.5% (95%CI: 2.9%-8.0%) and 12.2% (95%CI: 10.2%-14.1%) in the N1 cohort (N= 1768). Similarly, significant prognostic results were observed in the multivariate analysis adjusting for age, tumor size, grade, treatment as well as in HER2- patients (Table). Table: 138MO

Cohort N Risk groups Univariate HR Multivariate HR P-value
All patients
Overall DR N0, no chemo 1197 Intermediate vs Low 2.1 (1.4-3.4) 2.2 (1.3-3.5) <0.001
High vs Low 4.0 (2.6-6.2) 3.9 (2.5-6.3)
N1, no chemo 1319 High vs Low 2.5 (1.7-3.7) 2.2 (1.5-3.3) <0.001
Late DR N0 1285 High vs Low 2.1 (1.3-3.5) 2.3 (1.3-3.9) 0.004
N1 1768 High vs Low 2.3 (1.4-3.9) 2.0 (1.2-3.3) <0.001
HER2-
Overall DR N0, no chemo 978 Intermediate vs Low High vs Low 2.4 (1.4 -4.0) 2.5 (1.4-4.5) <0.001
4.6 (2.7-7.6) 5.0 (2.8-8.8)
N1, no chemo 1132 High vs Low 2.5 (1.6-3.7) 2.1 (1.4-3.3) <0.001
Late DR N0 1063 High vs Low 2.2 (1.2-3.9) 2.5 (1.4 -4.7) 0.006
N1 1507 High vs Low 2.5 (1.4-4.3) 2.1 (1.2-3.7) <0.001

Conclusions

BCI and BCIN+ are significantly prognostic for risk of overall DR (0-10y) and late DR (5-10y) for N0 and N1 patients, respectively. These results provide further validation of BCI clinical utility as an aid in the decision-making for adjuvant therapies for HR+ breast cancer.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

Biotheranostics, Inc., a Hologic Company.

Funding

Biotheranostics, Inc., a Hologic Company.

Disclosure

J.M. Bartlett: Financial Interests, Personal, Other, Honoraria: Nanostring Technologies, Inc., Oncology Education, Biotheranostics, A Hologic Company, MedcomXchange, Communications Inc; Financial Interests, Personal, Advisory Role: Insight Genetics, Inc., BioNTech AG, Biotheranostics, A Hologic Company, Pfizer, Rna Diagnostics Inc, oncoXchange/MedcomXchange Communications Inc., Herbert Smith French Solicitors, OncoCyte Corporation; Financial Interests, Personal, Funding: Thermo Fisher Scientific, Genoptix, Agendia, NanoString Technologies, Inc., Stratifyer GmbH, Biotheranostics, A Hologic Company; Financial Interests, Personal, Other, Patents - Jan 2017: Methods and Devices for Predicting Anthracycline Treatment Efficacy, US utility – 15/325,472; EPO – 15822898.1; Canada – not yet assigned Jan 2017: Systems, Devices and Methods for Constructing and Using a Biomarker, US utility – 15/328,108; EPO – 15824751.0; Canada – not yet assigned Oct 2016: Histone gene module predicts anthracycline benefit, PCT/CA2016/000247 Dec 2016: 95-Gene Signature of Residual Risk Following Endocrine Treatment, PCT/CA2016/000304 Dec 2016: Immune Gene Signature Predicts Anthracycline Benefit, PCT/CA2016/000305 June 2020: Use of Molecular Classifiers to Diagnose, Treat and Prognose Prostate Cancer, US Provisional 63/040.692, Disclosure Name: A Molecular Classifier for Personalized Risk Stratification for Patients with Prostate Cancer, Date: 21/08/2019: Other - Patents; Financial Interests, Personal, Other, Travel, Accomodations, Expenses: Biotheranostics, A Hologic Company, NanoString Technologies, Inc., Breast Cancer Society of Canada. J. Wong: Financial Interests, Personal, Full or part-time Employment: Biotheranostics, A Hologic Company; Financial Interests, Personal, Stocks/Shares: Biotheranostics, A Hologic Company; Financial Interests, Personal, Other, Travel, Accomodations, Expenses: Biotheranostics, A Hologic Company. G. Pond: Financial Interests, Personal, Other, Honoraria: Astra-Zeneca, Takeda; Financial Interests, Personal, Advisory Role: Merck, Profound Medical; Financial Interests, Personal, Stocks/Shares: Roche Ltd. Y. Zhang: Financial Interests, Personal, Full or part-time Employment: Biotheranostics, A Hologic Company; Financial Interests, Personal, Stocks/Shares: Biotheranostics, A Hologic Company; Financial Interests, Personal, Other, Travel, Accomodations, Expenses: Biotheranostics, A Hologic Company; Financial Interests, Personal, Other, Patents: Predicting likelihood of response to combination therapy, Registered United States of America Application no: 14/724,732 Application date: 5/28/2015 Registration No: 10,253,369 Registration date: 4/9/2019; Integration of tumor characteristics with breast cancer index, pending united States of America Application no: 15/349,915 Application date: 11/11/2016; Predicting breast cancer recurrence; Pending United States of America Application no: 14/483,108 Application date: 9/10/2014; Post-treatment breast cancer prognosis, Pending United States of America Application no: 15/298,128 Application date: 10/19/2016; Neuroendocrine tumors, Pending United States of America Application no: 15/656,998 Application date: 7/21/2017: Biotheranostics, A Hologic Company. R. Salunga: Financial Interests, Personal, Full or part-time Employment: Biotheranostics, A Hologic Company; Financial Interests, Personal, Stocks/Shares: Biotheranostics, A Hologic Company; Financial Interests, Institutional, Funding: Biotheranostics, A Hologic Company. C. Markopoulos: Financial Interests, Personal, Advisory Role: Exact Sciences. D. Rea: Financial Interests, Personal, Other, Honoraria: Daiichi Sankyo, Lilly, Novartis, Pfizer, Roche; Financial Interests, Personal, Advisory Role: Genomic Health, MSD Oncology; Financial Interests, Institutional, Funding: Celgene, Roche, Biotheranostics, A Hologic Company; Financial Interests, Personal, Other, Travel, Accomodations, Expenses: Daiichi Sankyo, Eisai, Novartis, Pfizer. C.A. Schnabel: Financial Interests, Personal, Full or part-time Employment: Biotheranostics, A Hologic Company; Financial Interests, Personal, Stocks/Shares: Biotheranostics, A Hologic Company; Financial Interests, Personal, Officer: Biotheranostics, A Hologic Company; Financial Interests, Personal, Other, Patents: Predicting likelihood of response to combination therapy, Registered United States of America Application no: 14/724,732 Application date: 5/28/2015 Registration No: 10,253,369 Registration date: 4/9/2019; Integration of tumor characteristics with breast cancer index, Pending United States of America Application no: 15/349,915 Application date: 11/11/2016; Predicting breast cancer recurrence; pending united states of america application no: 14/483,108 Application date: 9/10/2014; Post-treatment breast cancer prognosis, pending united states of america application no: 15/298,128 Application date: 10/19/2016; Neuroendocrine tumors, Pending United States of America Application no: 15/656,998 Application date: 7/21/2017: Biotheranostics, A Hologic Company; Financial Interests, Personal, Other, Travel, Accomodations, Expenses: Biotheranostics, A Hologic Company. K. Treuner: Financial Interests, Personal, Full or part-time Employment: Biotheranostics, A Hologic Company; Financial Interests, Personal, Stocks/Shares: Biotheranostics, A Hologic Company; Financial Interests, Personal, Other, Travel, Accomodations, Expenses: Biotheranostics, A Hologic Company; Financial Interests, Personal, Leadership Role: Biotheranostics, A Hologic Company. J. Bayani: Financial Interests, Personal, Other, Honoraria: Thermo Fisher Scientific, NanoString Technologies; Financial Interests, Personal and Institutional, Research Grant: Thermo Fisher Scientific. All other authors have declared no conflicts of interest.

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