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A Multigene Assay to Predict Recurrence of Tamoxifen-Treated, Node-Negative Breast Cancer

Open access
Paik, Soonmyung, Shak, Steven, Tang, Gong, Kim, Chungyeul, Baker, Joffre, Cronin, Maureen, Baehner, Frederick L., Walker, Michael G., Watson, Drew, Park, Taesung, Hiller, William, Fisher, Edwin R., Wickerham, D. Lawrence, Bryant, John, Wolmark, Norman·2004·New England Journal of Medicine

Abstract

BACKGROUND: The likelihood of distant recurrence in patients with breast cancer who have no involved lymph nodes and estrogen-receptor-positive tumors is poorly defined by clinical and histopathological measures. METHODS: We tested whether the results of a reverse-transcriptase-polymerase-chain-reaction (RT-PCR) assay of 21 prospectively selected genes in paraffin-embedded tumor tissue would correlate with the likelihood of distant recurrence in patients with node-negative, tamoxifen-treated breast cancer who were enrolled in the National Surgical Adjuvant Breast and Bowel Project clinical trial B-14. The levels of expression of 16 cancer-related genes and 5 reference genes were used in a prospectively defined algorithm to calculate a recurrence score and to determine a risk group (low, intermediate, or high) for each patient. RESULTS: Adequate RT-PCR profiles were obtained in 668 of 675 tumor blocks. The proportions of patients categorized as having a low, intermediate, or high risk by the RT-PCR assay were 51, 22, and 27 percent, respectively. The Kaplan-Meier estimates of the rates of distant recurrence at 10 years in the low-risk, intermediate-risk, and high-risk groups were 6.8 percent (95 percent confidence interval, 4.0 to 9.6), 14.3 percent (95 percent confidence interval, 8.3 to 20.3), and 30.5 percent (95 percent confidence interval, 23.6 to 37.4). The rate in the low-risk group was significantly lower than that in the high-risk group (P<0.001). In a multivariate Cox model, the recurrence score provided significant predictive power that was independent of age and tumor size (P<0.001). The recurrence score was also predictive of overall survival (P<0.001) and could be used as a continuous function to predict distant recurrence in individual patients. CONCLUSIONS: The recurrence score has been validated as quantifying the likelihood of distant recurrence in tamoxifen-treated patients with node-negative, estrogen-receptor-positive breast cancer.

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Metadata

Authors
Paik, S., Shak, S., Tang, G., Kim, C., Baker, J., Cronin, M., Baehner, F. L., Walker, M. G., Watson, D., Park, T., Hiller, W., Fisher, E. R., Wickerham, D. L., Bryant, J., & Wolmark, N.
Venue
New England Journal of Medicine
Published
2004-12-30
Volume
351
Issue
27
Pages
2817-2826
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
OpenAlex
W2105882193
Cited by
6,277
References
2
FWCI
85.95
Type
journal article
Language
en
Open access
bronze

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CoChat. (2026). Citation check: A Multigene Assay to Predict Recurrence of Tamoxifen-Treated, Node-Negative Breast Cancer. https://app.cochat.ai/papers/10.1056/nejmoa041588
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Paik, S., Shak, S., Tang, G., Kim, C., Baker, J., Cronin, M., Baehner, F. L., Walker, M. G., Watson, D., Park, T., Hiller, W., Fisher, E. R., Wickerham, D. L., Bryant, J., & Wolmark, N. (2004). A Multigene Assay to Predict Recurrence of Tamoxifen-Treated, Node-Negative Breast Cancer. New England Journal of Medicine. https://doi.org/10.1056/nejmoa041588

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