Prediction of late distant recurrence in patients with oestrogen-receptor-positive breast cancer: a prospective comparison of the breast-cancer index (BCI) assay, 21-gene recurrence score, and IHC4 in the TransATAC study population
Dennis C. Sgroi,Ivana Sestak,Jack Cuzick,Yi Zhang,Catherine A. Schnabel,Brock Schroeder,Mark G. Erlander,Anita K. Dunbier,Anita K. Dunbier,Kally Sidhu,Elena Lopez-Knowles,Paul E. Goss,Mitch Dowsett +12 more
TLDR
This prospective comparison study compared the prognostic ability of the breast-cancer index (BCI) assay, 21-gene recurrence score (Oncotype DX), and an immunohistochemical prognostic model (IHC4) for both early and late recurrence in patients with oestrogen-receptor-positive, node-negative breast cancer who took part in the Arimidex, Tamoxifen, Alone or in Combination clinical trial.Abstract:
Summary Background Biomarkers to improve the risk–benefit of extended adjuvant endocrine therapy for late recurrence in patients with oestrogen-receptor-positive breast cancer would be clinically valuable. We compared the prognostic ability of the breast-cancer index (BCI) assay, 21-gene recurrence score (Oncotype DX), and an immunohistochemical prognostic model (IHC4) for both early and late recurrence in patients with oestrogen-receptor-positive, node-negative (N0) disease who took part in the Arimidex, Tamoxifen, Alone or in Combination (ATAC) clinical trial. Methods In this prospective comparison study, we obtained archival tumour blocks from the TransATAC tissue bank from all postmenopausal patients with oestrogen-receptor-positive breast cancer from whom the 21-gene recurrence score and IHC4 values had already been derived. We did BCI analysis in matched samples with sufficient residual RNA using two BCI models—cubic (BCI-C) and linear (BCI-L)—using previously validated cutoffs. We assessed prognostic ability of BCI for distant recurrence over 10 years (the primary endpoint) and compared it with that of the 21-gene recurrence score and IHC4. We also tested the ability of the assays to predict early (0–5 years) and late (5–10 years) distant recurrence. To assess the ability of the biomarkers to predict recurrence beyond standard clinicopathological variables, we calculated the change in the likelihood-ratio χ 2 (LR-Δχ 2 ) from Cox proportional hazards models. Findings Suitable tissue was available from 665 patients with oestrogen-receptor-positive, N0 breast cancer for BCI analysis. The primary analysis showed significant differences in risk of distant recurrence over 10 years in the categorical BCI-C risk groups (p 2 =22·69; p 2 =13·68; p=0·0002) and IHC4 was similar (HR 1·69 [95% CI 1·51–2·56]; LR-Δχ 2 =22·83; p 2 =15·42, p 2 =18·48, p 2 =29·14, p 2 =7·97, p=0·0048; 21-gene recurrence score HR 1·13 [0·82–1·56], LR-Δχ 2 =0·48, p=0·47; IHC4 HR 1·30 [0·88–1·94], LR-Δχ 2 =1·59, p=0·20). Interpretation BCI-L was the only significant prognostic test for risk of both early and late distant recurrence and identified two risk populations for each timeframe. It could help to identify patients at high risk for late distant recurrence who might benefit from extended endocrine or other therapy. Funding Avon Foundation, National Institutes of Health, Breast Cancer Foundation, US Department of Defense Breast Cancer Research Program, Susan G Komen for the Cure, Breakthrough Breast Cancer through the Mary-Jean Mitchell Green Foundation, AstraZeneca, Cancer Research UK, and the National Institute for Health Research Biomedical Research Centre at the Royal Marsden (London, UK).read more
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Endocrine Therapy in Early Breast Cancer.
Katja Krauss,Elmar Stickeler +1 more
TL;DR: In the adjuvant setting this treatment reduces the 15-year mortality rates by about 30 and 40% with tamoxifen and aromatase inhibitor, respectively, respectively.
Journal ArticleDOI
Precision Medicine and the Role of Biomarkers of Radiotherapy Response in Breast Cancer.
James Meehan,Mark Gray,Mark Gray,Carlos Martinez-Perez,Charlene Kay,Lisa Y. Pang,Jennifer Fraser,Amy V. Poole,Ian H. Kunkler,Simon P. Langdon,David Argyle,Arran K Turnbull +11 more
TL;DR: The investigation of biomarkers related to radiation-induced toxicity could provide another means by which radiotherapy could become personalized, and studies that have used these methods to identify or develop prognostic/predictive signatures of radiosensitivity could be used in the future.
Journal ArticleDOI
Estrogen Receptor Expression in 21-Gene Recurrence Score Predicts Increased Late Recurrence for Estrogen-Positive/HER2-Negative Breast Cancer
Mitch Dowsett,Ivana Sestak,Richard Buus,Elena Lopez-Knowles,Elizabeth Mallon,Anthony Howell,John F. Forbes,Aman U. Buzdar,Jack Cuzick +8 more
TL;DR: Patients with tumors with high estrogen receptor transcript levels benefit most from 5 years' endocrine therapy but show increased recurrence rates after 5 years and may benefit from extended therapy.
Journal ArticleDOI
New Advances in Molecular Breast Cancer Pathology.
Emad A. Rakha,Fresia Pareja +1 more
TL;DR: An update on the molecular classification of BC and molecular prognostic assays is provided and Companion diagnostics, contribution of massive parallel sequencing and the use of liquid biopsy are highlighted.
Book ChapterDOI
Prognostic and Predictive Biomarkers of Endocrine Responsiveness for Estrogen Receptor Positive Breast Cancer
TL;DR: There is much work ahead toward the development of a molecular classification that informs the biology and novel therapeutic targets in high-risk disease as chemotherapy has only modest benefit in this population.
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TL;DR: The ability to identify patients who have a favourable prognosis could, after independent confirmation, allow clinicians to avoid adjuvant systemic therapy or to choose less aggressive therapeutic options.
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