TY - JOUR
T1 - 70-Gene signature as an aid to treatment decisions in early-stage breast cancer
AU - MINDACT Investigators
AU - Cardoso, Fatima
AU - Van't Veer, L. J.
AU - Bogaerts, J.
AU - Slaets, L.
AU - Viale, G.
AU - Delaloge, S.
AU - Pierga, J. Y.
AU - Brain, E.
AU - Causeret, S.
AU - DeLorenzi, M.
AU - Glas, A. M.
AU - Golfinopoulos, V.
AU - Goulioti, T.
AU - Knox, S.
AU - Matos, E.
AU - Meulemans, B.
AU - Neijenhuis, P. A.
AU - Nitz, U.
AU - Passalacqua, R.
AU - Ravdin, P.
AU - Rubio, I. T.
AU - Saghatchian, M.
AU - Smilde, T. J.
AU - Sotiriou, C.
AU - Stork, L.
AU - Straehle, C.
AU - Thomas, G.
AU - Thompson, A. M.
AU - Van Der Hoeven, J. M.
AU - Vuylsteke, P.
AU - Bernards, R.
AU - Tryfonidis, K.
AU - Rutgers, E.
AU - Piccart, M.
N1 - Publisher Copyright:
Copyright © 2016 Massachusetts Medical Society.
PY - 2016/8/25
Y1 - 2016/8/25
N2 - BACKGROUND: The 70-gene signature test (MammaPrint) has been shown to improve prediction of clinical outcome in women with early-stage breast cancer. We sought to provide prospective evidence of the clinical utility of the addition of the 70-gene signature to standard clinical-pathological criteria in selecting patients for adjuvant chemotherapy. METHODS: In this randomized, phase 3 study, we enrolled 6693 women with early-stage breast cancer and determined their genomic risk (using the 70-gene signature) and their clinical risk (using a modified version of Adjuvant! Online). Women at low clinical and genomic risk did not receive chemotherapy, whereas those at high clinical and genomic risk did receive such therapy. In patients with discordant risk results, either the genomic risk or the clinical risk was used to determine the use of chemotherapy. The primary goal was to assess whether, among patients with high-risk clinical features and a low-risk gene-expression profile who did not receive chemotherapy, the lower boundary of the 95% confidence interval for the rate of 5-year survival without distant metastasis would be 92% (i.e., the noninferiority boundary) or higher. RESULTS: A total of 1550 patients (23.2%) were deemed to be at high clinical risk and low genomic risk. At 5 years, the rate of survival without distant metastasis in this group was 94.7% (95% confidence interval, 92.5 to 96.2) among those not receiving chemotherapy. The absolute difference in this survival rate between these patients and those who received chemother apy was 1.5 percentage points, with the rate being lower without chemotherapy. Similar rates of survival without distant metastasis were reported in the subgroup of patients who had estrogen-receptor-positive, human epidermal growth factor receptor 2-negative, and either node-negative or node-positive disease. CONCLUSIONS: Among women with early-stage breast cancer who were at high clinical risk and low genomic risk for recurrence, the receipt of no chemotherapy on the basis of the 70-gene signature led to a 5-year rate of survival without distant metastasis that was 1.5 percentage points lower than the rate with chemotherapy. Given these findings, approximately 46% of women with breast cancer who are at high clinical risk might not require chemotherapy.
AB - BACKGROUND: The 70-gene signature test (MammaPrint) has been shown to improve prediction of clinical outcome in women with early-stage breast cancer. We sought to provide prospective evidence of the clinical utility of the addition of the 70-gene signature to standard clinical-pathological criteria in selecting patients for adjuvant chemotherapy. METHODS: In this randomized, phase 3 study, we enrolled 6693 women with early-stage breast cancer and determined their genomic risk (using the 70-gene signature) and their clinical risk (using a modified version of Adjuvant! Online). Women at low clinical and genomic risk did not receive chemotherapy, whereas those at high clinical and genomic risk did receive such therapy. In patients with discordant risk results, either the genomic risk or the clinical risk was used to determine the use of chemotherapy. The primary goal was to assess whether, among patients with high-risk clinical features and a low-risk gene-expression profile who did not receive chemotherapy, the lower boundary of the 95% confidence interval for the rate of 5-year survival without distant metastasis would be 92% (i.e., the noninferiority boundary) or higher. RESULTS: A total of 1550 patients (23.2%) were deemed to be at high clinical risk and low genomic risk. At 5 years, the rate of survival without distant metastasis in this group was 94.7% (95% confidence interval, 92.5 to 96.2) among those not receiving chemotherapy. The absolute difference in this survival rate between these patients and those who received chemother apy was 1.5 percentage points, with the rate being lower without chemotherapy. Similar rates of survival without distant metastasis were reported in the subgroup of patients who had estrogen-receptor-positive, human epidermal growth factor receptor 2-negative, and either node-negative or node-positive disease. CONCLUSIONS: Among women with early-stage breast cancer who were at high clinical risk and low genomic risk for recurrence, the receipt of no chemotherapy on the basis of the 70-gene signature led to a 5-year rate of survival without distant metastasis that was 1.5 percentage points lower than the rate with chemotherapy. Given these findings, approximately 46% of women with breast cancer who are at high clinical risk might not require chemotherapy.
UR - http://www.scopus.com/inward/record.url?scp=84984697640&partnerID=8YFLogxK
U2 - 10.1056/NEJMoa1602253
DO - 10.1056/NEJMoa1602253
M3 - Article
C2 - 27557300
AN - SCOPUS:84984697640
SN - 0028-4793
VL - 375
SP - 717
EP - 729
JO - New England Journal of Medicine
JF - New England Journal of Medicine
IS - 8
ER -