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JCO Early Release, published online ahead of print May 23 2006
Journal of Clinical Oncology, 10.1200/JCO.2005.04.7985

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Received November 10, 2005
Accepted April 18, 2006

Gene Expression and Benefit of Chemotherapy in Women With Node-Negative, Estrogen Receptor-Positive Breast Cancer

Soonmyung Paik *, Gong Tang , Steven Shak , Chungyeul Kim , Joffre Baker , Wanseop Kim , Maureen Cronin , Frederick L. Baehner , Drew Watson , John Bryant , Joseph P. Costantino , Charles E. Geyer Jr , D. Lawrence Wickerham , and Norman Wolmark

From the Division of Pathology, Operations Center, and Biostatistical Center, National Surgical Adjuvant Breast and Bowel Project; Department of Biostatistics, School of Public Health, University of Pittsburgh; Department of Human Oncology, Allegheny General Hospital, Pittsburgh, PA; Genomic Health Inc, Redwood City, CA; and University of California, San Francisco, San Francisco, CA.

* To whom correspondence should be addressed. E-mail: soon.paik{at}nsabp.org

Purpose: The 21-gene recurrence score (RS) assay quantifies the likelihood of distant recurrence in women with estrogen receptor-positive, lymph node-negative breast cancer treated with adjuvant tamoxifen. The relationship between the RS and chemotherapy benefit is not known.

Methods: The RS was measured in tumors from the tamoxifen-treated and tamoxifen plus chemotherapy-treated patients in the National Surgical Adjuvant Breast and Bowel Project (NSABP) B20 trial. Cox proportional hazards models were utilized to test for interaction between chemotherapy treatment and the RS.

Results: A total of 651 patients were assessable (227 randomly assigned to tamoxifen and 424 randomly assigned to tamoxifen plus chemotherapy). The test for interaction between chemotherapy treatment and RS was statistically significant (P = .038). Patients with high-RS (≥ 31) tumors (ie, high risk of recurrence) had a large benefit from chemotherapy (relative risk, 0.26; 95% CI, 0.13 to 0.53; absolute decrease in 10-year distant recurrence rate: mean, 27.6%; SE, 8.0%). Patients with low-RS (< 18) tumors derived minimal, if any, benefit from chemotherapy treatment (relative risk, 1.31; 95% CI, 0.46 to 3.78; absolute decrease in distant recurrence rate at 10 years: mean, -1.1%; SE, 2.2%). Patients with intermediate-RS tumors did not appear to have a large benefit, but the uncertainty in the estimate can not exclude a clinically important benefit.

Conclusion: The RS assay not only quantifies the likelihood of breast cancer recurrence in women with node-negative, estrogen receptor-positive breast cancer, but also predicts the magnitude of chemotherapy benefit.


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