Originally published as JCO Early Release 10.1200/JCO.2007.14.4501 on August 4 2008

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Prognostic Utility of the 21-Gene Assay in Hormone Receptor–Positive Operable Breast Cancer Compared With Classical Clinicopathologic Features

Lori J. Goldstein, Robert Gray, Sunil Badve, Barrett H. Childs, Carl Yoshizawa, Steve Rowley, Steven Shak, Frederick L. Baehner, Peter M. Ravdin, Nancy E. Davidson, George W. Sledge, Jr, Edith A. Perez, Lawrence N. Shulman, Silvana Martino, Joseph A. Sparano

From the Eastern Cooperative Oncology Group, Boston, MA; Sanofi-aventis, Bridgewater, NJ; Genomic Health, Inc, Redwood City, CA; The University of Texas M.D. Anderson Cancer Center, Houston; Southwest Oncology Group, San Antonio, TX; North Central Cancer Treatment Group, Rochester, MN; Cancer and Leukemia Group B, Chicago, IL

Corresponding author: Joseph A. Sparano, MD, Albert Einstein Cancer Center, Montefiore Medical Center, Weiler Division, 1825 Eastchester Rd, 2 South, Rm 47-48, Bronx, NY 10461; e-mail: jsparano{at}montefiore.org

Purpose Adjuvant! is a standardized validated decision aid that projects outcomes in operable breast cancer based on classical clinicopathologic features and therapy. Genomic classifiers offer the potential to more accurately identify individuals who benefit from chemotherapy than clinicopathologic features.

Patients and Methods A sample of 465 patients with hormone receptor (HR) –positive breast cancer with zero to three positive axillary nodes who did (n = 99) or did not have recurrence after chemohormonal therapy had tumor tissue evaluated using a 21-gene assay. Histologic grade and HR expression were evaluated locally and in a central laboratory.

Results Recurrence Score (RS) was a highly significant predictor of recurrence, including node-negative and node-positive disease (P < .001 for both) and when adjusted for other clinical variables. RS also predicted recurrence more accurately than clinical variables when integrated by an algorithm modeled after Adjuvant! that was adjusted to 5-year outcomes. The 5-year recurrence rate was only 5% or less for the estimated 46% of patients who have a low RS (< 18).

Conclusion The 21-gene assay was a more accurate predictor of relapse than standard clinical features for individual patients with HR-positive operable breast cancer treated with chemohormonal therapy and provides information that is complementary to features typically used in anatomic staging, such as tumor size and lymph node involvement. The 21-gene assay may be used to select low-risk patients for abbreviated chemotherapy regimens similar to those used in our study or high-risk patients for more aggressive regimens or clinical trials evaluating novel treatments.

published online ahead of print at www.jco.org August 4, 2008.

Supported in part by the United States Department of Health and Human Services and the National Institutes of Health (Grants No. CA23318 to the Eastern Cooperative Oncology Group [ECOG] statistical center, CA66636 to the ECOG data management center, CA21115 to the ECOG coordinating center, CA25224 to North Central Cancer Treatment Group, CA32291 to Cancer and Leukemia Group B, and CA32012 to Southwest Oncology Group), and by a grant from Sanofi-aventis.

Presented in part at the 43rd Annual Meeting of the American Society of Clinical Oncology, June 1-5, 2007, Chicago, IL; and at the San Antonio Breast Cancer Symposium, San Antonio, TX, December 13-16, 2007.

Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this article.

Clinical trial information can be found for the following: NCT00003519 [ClinicalTrials.gov] .

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