• J. Clin. Oncol. · Aug 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, D Lawrence Wickerham, and Norman Wolmark.
    • Division of Pathology, Operations Center, and Biostatistical Center, National Surgical Adjuvant Breast and Bowel Project, Pittsburgh, PA 15212, USA. soon.paik@nsabp.org
    • J. Clin. Oncol. 2006 Aug 10; 24 (23): 3726-34.

    PurposeThe 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.MethodsThe 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.ResultsA 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 (> or = 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.ConclusionThe 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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