Anthracyclines
➤ The clinician should NOT use TOP2A gene amplification or TOP2A
protein expression by IHC to guide adjuvant chemotherapy selection.
(Moderate Recommendation; EB-H)
➤ The clinician should NOT use HER2 and TOP2A gene coamplification;
CEP17 duplication; or TIMP-1, FOXP3, or p53 to guide adjuvant
chemotherapy selection. (Moderate Recommendation; EB-I)
Trastuzumab
➤ If a patient has HER2-positive breast cancer, the clinician should
NOT use phosphatase and tensin homolog (PTEN) to guide adjuvant
therapy selection. (Moderate Recommendation; EB-I)
➤ If a patient has HER2-positive breast cancer, the clinician should NOT
use soluble HER2 levels to guide selection of type of adjuvant therapy.
(Moderate Recommendation; EB-L)
Table 1. Requirements for a Marker-Based Test to Reach
Level IB Evidence of Clinical Utility on the Basis of
Prospective-Retrospective Studies
Requirements
1. Adequate amounts of archived specimen must be available from enough
patients from a prospective trial (which for predictive factors should
generally be a randomized design) for analyses to have adequate
statistical power and for the patients included in the evaluation to be
clearly representative of the patients in the trial.
2. The marker-based test should be analytically and preanalytically
validated for use with archived specimens.
3. The plan for marker evaluation should be completely specified in writing
before the performance of marker assays on archived specimens and
should be focused on the evaluation of a completely defined marker-
based test.
4. The results from archived specimens should be validated by using
specimens from one or more similar, but separate studies.
NOTE. Adapted from Simon et al. J Natl Cancer Inst. 2009;101:1446-1452.
Abbreviations
ER, estrogen receptor; HER2, human epidermal growth factor receptor 2; IHC,
immunohistochemistry; PR, progesterone receptor; PTEN, phosphatase and tensin homolog ;
RS, recurrence score; TN, triple negative
