Oncotype DX for breast cancer

^[1]^[2]^[3]^[4]^[5]

Indications

quantifies the likelihood of disease recurrence in women with early-stage breast cancer
assesses likely benefit from certain types of chemotherapy
developed for women with early-stage invasive breast cancer who are estrogen receptor positive with negative lymph nodes
assessment of need for chemotherapy* in women with hormone receptor positive, axillary node negative breast cancer

obtained fron tissue removed during the original surgery (lumpectomy, mastectomy, or core biopsy)
thin sections of the formalin-fixed, paraffin-embedded tissue are sent to Genomic Health

RT-PCR analysis of a panel of 21 genes obtained from biopsy
- expression of 16 cancer-related genes^[2]
  - Ki67, STK15, Survivin or BIRC5, CCNB1 or cyclin B1, MYBL2, GRB7, HER2, ER, PGR, BCL2, SCUBE2, MMP11 or stromelysin 3, CTSL2 or cathepsin L2, GSTM1, CD68, & BAG1
- 5 reference genes
  - ACTB (beta-actin), GAPDH, RPLPO, GUS, TFRC^[2]
recurrence Score is a number between 0 & 100 that corresponds to a specific likelihood of breast cancer recurrence within 10 years of the initial diagnosis

↑ Wikipedia: Oncotype DX http://en.wikipedia.org/wiki/Oncotype_DX
↑ ^2.0 ^2.1 ^2.2 Paik S, Tang G, Shak S et al Gene expression and benefit of chemotherapy in women with node-negative, estrogen receptor-positive breast cancer. J Clin Oncol. 2006 Aug 10;24(23):3726-34 PMID: https://www.ncbi.nlm.nih.gov/pubmed/16720680
↑ ^3.0 ^3.1 Sparano JA, Gray RJ, Makower DF et al Adjuvant Chemotherapy Guided by a 21-Gene Expression Assay in Breast Cancer. N Engl J Med. June 3, 2018 PMID: https://www.ncbi.nlm.nih.gov/pubmed/29860917 https://www.nejm.org/doi/full/10.1056/NEJMoa1804710
ASCO News Release. June 3, 2018 Most Women With Early Stage Breast Cancer Can Forgo Chemotherapy When Guided by a Diagnostic Test. https://www.asco.org/about-asco/press-center/news-releases/most-women-early-stage-breast-cancer-can-forgo-chemotherapy
↑ Sparano JA, Gray RJ, Makower DF et al Prospective Validation of a 21-Gene Expression Assay in Breast Cancer. N Engl J Med. 2015 Nov 19;373(21):2005-14. Epub 2015 Sep 27. PMID: https://www.ncbi.nlm.nih.gov/pubmed/26412349 Free PMC Article
↑ ARUP Consult: Breast Cancer Biomarkers The Physician's Guide to Laboratory Test Selection & Interpretation https://www.arupconsult.com/content/breast-cancer
ARUP Consult: Hereditary Breast and Ovarian Cancer https://arupconsult.com/ati/hereditary-breast-and-ovarian-cancer