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Goldstein LJ , Gray R , Badve S , Childs BH , Yoshizawa C , Rowley S , Shak S , Baehner FL , Ravdin PM , Davidson NE , Sledge GW Jr , Perez EA , Shulman LN , Martino S , Sparano JA
Prognostic utility of the 21-gene assay in hormone receptor-positive operable breast cancer compared with classical clinicopathologic features
J Clin Oncol. 2008 Sep 1;26(25) :4063-71
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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.
Goldstein, Lori J Gray, Robert Badve, Sunil Childs, Barrett H Yoshizawa, Carl Rowley, Steve Shak, Steven Baehner, Frederick L Ravdin, Peter M Davidson, Nancy E Sledge, George W Jr Perez, Edith A Shulman, Lawrence N Martino, Silvana Sparano, Joseph A CA21115/CA/United States NCI CA23318/CA/United States NCI CA25224/CA/United States NCI CA32012/CA/United States NCI CA32291/CA/United States NCI CA66636/CA/United States NCI Research Support, N.I.H., Extramural Research Support, Non-U.S. Gov't United States Journal of clinical oncology : official journal of the American Society of Clinical Oncology J Clin Oncol. 2008 Sep 1;26(25):4063-71. Epub 2008 Aug 4.