Supplementary Tables from Development of Circulating Tumor Cell-Endocrine Therapy Index in Patients with Hormone Receptor–Positive Breast Cancer

Table S1. Antibodies used for CTC and tissue studies. Table S2. Stage 2 stopping rules for the cumulative number of successfully assayed patients. Table S3. A. CTC-Enumeration Points based on CTC Enumeration B. CTC-Bio-Pointsa Footnotes:aOnly aliquots with CTC {greater than or equal to}5/7.5 ml WB evaluated bLow or negative ER expression is weighed more than BCL-2, HER2, and Ki67 due to its fundamental role in endocrine responsiveness. C. Calculation of CTC-ETI Scores. D. CTC-ETI Categories. Footnote: Abbreviations: CTC= circulating tumor cells; ER = estrogen receptor; ET= Endocrine Therapy; MBC = metastatic breast cancer; ET= endocrine therapy. Table S4. CTC-ETI determination in cultured human breast cancer cell lines spiked into normal human blood and evaluated by the CellSearch® system. Table S5. Examples of low, intermediate, and high CTC-ETI from patient samples. A. LOW CTC-ETI Patient # 5 (Primary Tissue: ER 90% positive, HER2 negative by FISH; Metastatic tissue: ER positive, HER2 negative by FISH)* B. INTERMEDIATE CTC-ETI Patient #4 (Primary Tissue: ER {greater than or equal to}95% positive, HER2 0 by IHC; Metastatic tissue: insufficient tissue to evaluate ER and HER2)* C. HIGH CTC-ETI Patient # 3 (Primary Tissue: ER 60% positive, HER2 1+/2+ by IHC; Metastatic tissue: ER 75% positive; HER2 1+ by IHC)* Footnote: *ER and HER2 as per initial clinical laboratory using the laboratory's criteria for positivity or negativity. Table S6.< CTC-ETI for each patient. Footnote: aAF =Analytical Failure (CTCbTF=Technical Failure (Machine failure in at least one of 4 aliquots). Table S7. Concordance between biomarkers in primary and metastatic tissues and CTC. aKappa score for concordance between CTC and tissue biomarker for respective biomarker.