Gene Score Identified Breast Cancer Patients Who Don’t Benefit From Chemotherapy

Dr. Kathy D. Miller, MD Indiana University Melvin and Bren Simon Cancer Interview with:
Dr. Kathy D. Miller, MD
Indiana University Melvin and Bren Simon Cancer Center

Medical Research: What is the background for this study? What are the main findings?

Dr. Miller: Previous studies had found a small but real benefit with the addition of chemotherapy to anti-estrogen treatment in patients with hormone sensitive disease. The challenge for patients and clinicians has always been that the benefit of chemotherapy is quite small and the toxicity can be substantial. The Oncotype Dx recurrence score assay was developed to identify patients who could safely be treated with anti-estrogen therapy alone (and conversely those who truly need and would derive a much larger benefit from chemotherapy). When the Oncotype Dx RS was applied to samples stored from a previous randomized trial, patients with low risk scores didn’t seem to benefit from chemotherapy. While those initial results had some impact on treatment, many were concerned about eliminating chemotherapy on the basis of one small retrospective trial.

The overall trial enrolled 10,253 women. 1626 (15.9%) had a Recurrence Score of 0-10 and were assigned to receive antiestrogen therapy alone without chemotherapy. After five years 99.3% (98.7, 99.6%) for were free of distant relapse (that is to say, 99.3% of women had NOT had recurrence of breast cancer at distant sites in the body). Overall survival was 98%.

Medical Research: What should clinicians and patients take away from your report?

Dr. Miller: This study shows that the Oncotype DX Recurrence Score identifies a group patients with stage I/II hormone sensitive disease with an excellent prognosis after anti-estrogen therapy alone. The risk of distant recurrence is so low in this group that there would be no possible benefit from chemotherapy.

Medical Research: What recommendations do you have for future research as a result of this study?

Dr. Miller: We will need additional follow-up to determine the benefit (or lack of benefit) of chemotherapy in patients with Recurrence Scores between 11-25. We are also interested in comparing these results with results using other genetic assays.


Joseph A. Sparano, Robert J. Gray, Della F. Makower, Kathleen I. Pritchard, Kathy S. Albain, Daniel F. Hayes, Charles E. Geyer, Elizabeth C. Dees, Edith A. Perez, John A. Olson, JoAnne Zujewski, Tracy Lively, Sunil S. Badve, Thomas J. Saphner, Lynne I. Wagner, Timothy J. Whelan, Matthew J. Ellis, Soonmyung Paik, William C. Wood, Peter Ravdin, Maccon M. Keane, Henry L. Gomez Moreno, Pavan S. Reddy, Timothy F. Goggins, Ingrid A. Mayer, Adam M. Brufsky, Deborah L. Toppmeyer, Virginia G. Kaklamani, James N. Atkins, Jeffrey L. Berenberg, George W. Sledge. Prospective Validation of a 21-Gene Expression Assay in Breast Cancer. New England Journal of Medicine, 2015; 150927220039001 DOI: 1056/NEJMoa1510764

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Dr. Kathy D. Miller, MD (2015). Gene Score Identified Breast Cancer Patients Who Don’t Benefit From Chemotherapy