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Pharmaceuticals 2015, 8(1), 107-122;

A Retrospective Study of the Impact of 21-Gene Recurrence Score Assay on Treatment Choice in Node Positive Micrometastatic Breast Cancer

Main Line HealthCare Breast Surgical Specialists, Susquehanna Bank Building, 101 South Bryn Mawr Ave, Suite 201, Bryn Mawr, PA 19010, USA
Rena Rowan Breast Center at the Abramson Cancer Center of the University of Pennsylvania, 3400 Civic Center Boulevard, 3 West Pavilion, Philadelphia, PA 19104, USA
Penn State Hershey Breast Center, Penn State College of Medicine, 30 Hope Drive, MC EC008, P.O. Box 859, Hershey, Pennsylvania 17033, USA
Lee Moffitt Cancer Center and Research Institute, 12902 Magnolia Drive, Tampa, FL 33612, USA
The George Washington University, GW Medical Faculty Associates, 2300 M Street, NW 8th floor, DC Level, Washington, DC 20037, USA
Rocky Mountain Cancer Centers, 4700 East Hale Parkway, Suite 400, Denver, CO 80220, USA
University of Maryland St. Joseph Medical Center, 7601 Osler Drive, Towson, MD 21204, USA
Midwest Cancer Care Physicians at the Menorah Medical Center, 2316 East Meyer Boulevard, 1 West, Kansas City, MO 64132, USA
The Maine Center for Cancer Medicine, 100 Campus Drive, unit 108, Scarborough, Maine 04074, USA
Genomic Health, Inc., 301 Penobscot Drive, Redwood City, CA 94063, USA
Partnership for Health Analytic Research, LLC, 280 S. Beverly Drive, Suite 404, Beverly Hills, CA 90212, USA
Keck School of Medicine, University of Southern California, Los Angeles, CA 90089, USA
Author to whom correspondence should be addressed.
These authors contributed equally to this work.
Academic Editor: Jean Jacques Vanden Eynde
Received: 21 November 2014 / Revised: 4 January 2015 / Accepted: 9 February 2015 / Published: 17 March 2015
PDF [699 KB, uploaded 17 March 2015]


To assess clinical utility of the 21-gene assay (Oncotype DX® Recurrence Score®), we determined whether women with HER2(−)/ER+ pN1mi breast cancer with low (<18) Recurrence Scores results are given adjuvant chemotherapy in a lower proportion than those with high scores (≥31). This was a multicenter chart review of ≥18 year old women with pN1mi breast cancer, HER2(−)/ER+ tumors, ductal/lobular/mixed histology, with the assay ordered on or after 1 January 2007. One hundred and eighty one patients had a mean age of 60.7 years; 82.9% had ECOG performance status 0; 33.7% had hypertension, 22.7% had osteoporosis, 18.8% had osteoarthritis, and 8.8% had type-2 diabetes. Mean Recurrence Score was 17.8 (range: 0–50). 48.6% had a mastectomy; 55.8% had a lumpectomy. 19.8% of low-risk group patients were recommended chemotherapy vs. 57.9% in the intermediate-risk group and 100% in the high-risk group (p < 0.001). A total of 80.2% of the low-risk group were recommended endocrine therapy alone, while 77.8% of the high-risk group were recommended both endocrine and chemotherapy (p < 0.001). The Oncotype DX Recurrence Score result provides actionable information that can be incorporated into treatment planning for women with HER2(−)/ER+ pN1mi breast cancer. The Recurrence Score result has clinical utility in treatment planning for HER2(−)/ER+ pN1mi breast cancer patients. View Full-Text
Keywords: clinical utility; genomics; recurrence risk; chemotherapy; breast cancer clinical utility; genomics; recurrence risk; chemotherapy; breast cancer
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited (CC BY 4.0).

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Frazier, T.G.; Fox, K.R.; Smith, J.S.; Laronga, C.; McSwain, A.; Paul, D.; Schultz, M.; Stilwill, J.; Teal, C.; Weisberg, T.; Vacchino, J.F.; Sing, A.P.; Cherepanov, D.; Hsiao, W.; Chang, E.; Broder, M.S. A Retrospective Study of the Impact of 21-Gene Recurrence Score Assay on Treatment Choice in Node Positive Micrometastatic Breast Cancer. Pharmaceuticals 2015, 8, 107-122.

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