Breast Cancer Index^SM

Changing the way you stratify breast cancer recurrence risk

Accurate assessment of prognosis in patients with early stage breast cancer is essential to guiding adjuvant treatment decisions. Traditionally, evaluation of prognosis and risk of recurrence has been based on clinicopathologic features, such as age, tumor size, and grade which can be subjective. Treating patients identified with features of intermediate risk remain a clinical challenge.

Traditional risk stratification is inadequate for optimal therapy selection

Risk stratification with a traditional method such as St. Gallen Criteria¹ classifies as many as 86% of patients as intermediate – a designation that is problematic as well as inaccurate. Without a clearer delineation of high or low risk, there is real danger of under treating higher risk patients and over treating lower risk patients.

Improving breast cancer risk stratification for better patient management

The Breast Cancer Index improves patient management by refining risk assessment and identifying patients likely to benefit from endocrine therapy, and whose tumors are likely to be sensitive or resistant to chemotherapy.

A combination of two powerful indexes

By simultaneous assessment of H/I^SM (HOXB13:IL17BR) and MGI^SM (Molecular Grade Index) , the Breast Cancer Index has the capability of significantly re-stratifying the majority of “intermediate risk score” patients into either low or high-risk groups. This in turn enables the treating oncologist to objectively identify those patients who are in need of, and would most likely benefit from, certain therapies.

Independent and significant prognostic information

H/I and MGI independently evaluate two distinct biological pathways.

• H/I is a two-gene index that stratifies ER-positive breast cancer into low or high risk for recurrence and is predictive of benefit from endocrine therapy.^2,3
• MGI is a five-gene index that provides quantitative and objective molecular assessment of tumor grade and proliferative status, stratifies breast cancers into low or high risk for recurrence, and identifies tumors likely to be responsive to chemotherapy.^3-5

These two biomarkers, when combined into the molecular diagnostic Breast Cancer Index, provide a more complete picture of both risk of recurrence and viable therapeutic options, such as endocrine therapy or chemotherapy, for each individual patient.

The Breast Cancer Index delivers significant clinical benefits

• Indication of likely sensitivity or resistance to specific therapeutic agents
• Prediction of distant metastasis-free survival
• Accurate tumor grading

References:
1. Goldhirsch A, Coates AS, Gelber RD, Glick JH, Thurlimann B, Senn HJ. First – select the target: better choice of adjuvant treatments for breast cancer patients. Ann Oncol. 2006;17(12):1772-1776.
2. Data on file, bioTheranostics Inc, San Diego, CA.
3. Ma XJ, Salunga R, Dahiya S, et al. A five-gene molecular grade index and HOXB13:IL17BR are complementary prognostic factors in early stage breast cancer. Clin Cancer Res. 2008;14(9):2601-2608.
4. Page DL, Gray R, Allred DC, et al. Prediction of node-negative breast cancer outcome by histologic grading and S-phase analysis by flow cytometry: an Eastern Cooperative Oncology Group Study (2192). Am J Clin Oncol. 2001;24(1):10-18.
5. Ma X-J, Erlander M, Goss P, et al. A robust five-gene RT-PCR molecular grade index stratifies recurrence risk for grade 2 tumors, predicts chemo-sensitivity and is compatible with formalin-fixed paraffin-embedded tissue. Paper presented at: 25th Annual Miami Breast Cancer Conference; February 20-23, 2008; Orlando, FL.