Predictive testing for selection of patients for extended endocrine therapy: Clinical utilization of Breast Cancer Index (BCI) in early-stage, ER+, LN- breast cancer.

Authors

Stephen Malamud

Stephen C. Malamud

Beth Israel Medcl Ctr, New York, NY

Stephen C. Malamud , Brock Schroeder , Theresa N. Operana , Catherine A. Schnabel

Organizations

Beth Israel Medcl Ctr, New York, NY, bioTheranostics, San Diego, CA

Research Funding

No funding sources reported

Background: Randomized trials have demonstrated significant but modest (3-5%) benefit from extended (10y) endocrine therapy (EET) vs 5y in pts with early stage ER+ breast cancer. Clinical practice guidelines have speculated on the risk vs benefit of EET in pts with a low clinicopathologic risk profile. Breast Cancer Index (BCI) is a gene expression-based test that that is prognostic for risk of late (> 5y) recurrence and predictive of EET benefit. This study examined the clinical utility and utilization of BCI in clinical practice, and its ability to identify pts likely to benefit from EET in an otherwise low risk population. Methods: Consecutive cases (N = 853) from LN- pts submitted for BCI prognostic and BCI predictive [HoxB13/IL17BR (H/I) ratio] analyses were investigated. Patient characteristics, clinician testing patterns, and clinical results were analyzed descriptively. Results: Patient characteristics are shown in the top table. BCI identified 54% and 46% as having low and high risk of late recurrence, respectively. Predictive testing identified 42% of pts with a high likelihood vs. 58% with a low likelihood of benefit from EET. The bottom table shows the integrated prognostic and predictive results. In the subset of pts with a low clinicopathologic risk profile (LN-, T1, Grade 1-2, HER2-neg; n = 321), BCI identified 23% of pts with both a high risk of late recurrence (mean, 7.1% DRR) and likely to benefit from EET. Physicians utilized BCI across a range of intervals from time of diagnosis: 11% < 2y; 14% ≥ 2 to < 4y; 57% ≥ 4 to < 6y; and 18% ≥ 6y. Conclusions: Data from this large retrospective analysis further define BCI clinical utility in selection of which early-stage, ER+ pts are at risk of late recurrence and likely to benefit from EET vs those that may be adequately treated with 5y of endocrine therapy.

Characteristics (N = 853)

Mean Age
> 65y
57y
27%
Size
≤ 1cm
> 1 - ≤ 2cm
> 2 - ≤ 5 cm
>5 cm
%
26
49
23
2%
Grade
1
2
3
%
29
52
19
HER2
Neg
Pos
%
89
19

Stratification by BCI prognostic (risk of late recurrence) and BCI predictive (H/I)

All pts (N=853)
Likelihood of Benefit
Risk GroupLowHigh
Low43%11%
High15%31%
LN-, T1, Grade 1-2, HER2- (n = 321)
LowHigh
Low54%12%
High11%23%

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Abstract Details

Meeting

2015 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Breast Cancer—HER2/ER

Track

Breast Cancer

Sub Track

ER+

Citation

J Clin Oncol 33, 2015 (suppl; abstr 545)

DOI

10.1200/jco.2015.33.15_suppl.545

Abstract #

545

Poster Bd #

33

Abstract Disclosures