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Originally published as JCO Early Release 10.1200/JCO.2005.04.7985 on May 23 2006

Journal of Clinical Oncology, Vol 24, No 23 (August 10), 2006: pp. 3726-3734
© 2006 American Society of Clinical Oncology.
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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, 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

Address reprint requests to Soonmyung Paik, MD, NSABP Foundation, Four Allegheny Center, 5th floor, East Commons Professional Building, Pittsburgh, PA 15212; 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.

published online ahead of print at www.jco.org on May 23, 2006.

Supported by Public Health Service Grants No. U10-CA-12027, U10-CA-69651, U10-CA-37377, and U10-CA-69974 from the National Cancer Institute, National Institutes of Health, Bethesda, MD; and by Genomic Health Inc, Redwood City, CA.

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

Terms in blue are defined in the glossary, found at the end of this article and online at www.jco.org.


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F. Andre, C. Hatzis, K. Anderson, C. Sotiriou, C. Mazouni, J. Mejia, B. Wang, G. N. Hortobagyi, W. F. Symmans, and L. Pusztai
Microtubule-Associated Protein-tau is a Bifunctional Predictor of Endocrine Sensitivity and Chemotherapy Resistance in Estrogen Receptor-Positive Breast Cancer
Clin. Cancer Res., April 1, 2007; 13(7): 2061 - 2067.
[Abstract] [Full Text] [PDF]

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J. P. A. Ioannidis
Is Molecular Profiling Ready for Use in Clinical Decision Making?
Oncologist, March 1, 2007; 12(3): 301 - 311.
[Abstract] [Full Text] [PDF]

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L. D. True and X. Gao
Quantum Dots for Molecular Pathology: Their Time Has Arrived
J. Mol. Diagn., February 1, 2007; 9(1): 7 - 11.
[Abstract] [Full Text] [PDF]

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R. S. Herbst and S. M. Lippman
Molecular Signatures of Lung Cancer -- Toward Personalized Therapy
N. Engl. J. Med., January 4, 2007; 356(1): 76 - 78.
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M. Dowsett
Estrogen Receptor: Methodology Matters
J. Clin. Oncol., December 20, 2006; 24(36): 5626 - 5628.
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M. N. Levine and T. Whelan
Adjuvant Chemotherapy for Breast Cancer -- 30 Years Later
N. Engl. J. Med., November 2, 2006; 355(18): 1920 - 1922.
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A. C. Wolff and N. E. Davidson
Still Waiting After 110 Years: The Optimal Use of Ovarian Ablation As Adjuvant Therapy for Breast Cancer
J. Clin. Oncol., November 1, 2006; 24(31): 4949 - 4951.
[Full Text] [PDF]

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S. M. Swain
A Step in the Right Direction
J. Clin. Oncol., August 10, 2006; 24(23): 3717 - 3718.
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