| Content Provider |
World Health Organization (WHO)-Global Index Medicus |
| Author |
Straehle, Carolyn Van Der Hoeven, Jacobus M. Sotiriou, Christos Brain, Etienne Delorenzi, Mauro Meulemans, Bart Knox, Susan Rubio, Isabel T. Thompson, Alastair M. Bogaerts, Jan Slaets, Leen Goulioti, Theodora Tryfonidis, Konstantinos Bernards, René Van't Veer, Laura J. Pierga, Jean-yves Matos, Erika Nitz, Ulrike Delaloge, Suzette Viale, Giuseppe Smilde, Tineke J. Golfinopoulos, Vassilis Causeret, Sylvain Glas, Annuska M. Vuylsteke, Peter Saghatchian, Mahasti Ravdin, Peter Stork, Lisette Cardoso, Fatima Rutgers, Emiel Piccart, Martine Passalacqua, Rodolfo Thomas, Geraldine Neijenhuis, Peter A. |
| Description |
Author Affiliation: Cardoso F ( From Champalimaud Clinical Center-Champalimaud Foundation, Lisbon, Portugal (F.C.)); van't Veer LJ ( From Champalimaud Clinical Center-Champalimaud Foundation, Lisbon, Portugal (F.C.)); Bogaerts J ( From Champalimaud Clinical Center-Champalimaud Foundation, Lisbon, Portugal (F.C.)); Slaets L ( From Champalimaud Clinical Center-Champalimaud Foundation, Lisbon, Portugal (F.C.)); Viale G ( From Champalimaud Clinical Center-Champalimaud Foundation, Lisbon, Portugal (F.C.)); Delaloge S ( From Champalimaud Clinical Center-Champalimaud Foundation, Lisbon, Portugal (F.C.)); Pierga JY ( From Champalimaud Clinical Center-Champalimaud Foundation, Lisbon, Portugal (F.C.)); Brain E ( From Champalimaud Clinical Center-Champalimaud Foundation, Lisbon, Portugal (F.C.)); Causeret S ( From Champalimaud Clinical Center-Champalimaud Foundation, Lisbon, Portugal (F.C.)); DeLorenzi M ( From Champalimaud Clinical Center-Champalimaud Foundation, Lisbon, Portugal (F.C.)); Glas AM ( From Champalimaud Clinical Center-Champalimaud Foundation, Lisbon, Portugal (F.C.)); Golfinopoulos V ( From Champalimaud Clinical Center-Champalimaud Foundation, Lisbon, Portugal (F.C.)); Goulioti T ( From Champalimaud Clinical Center-Champalimaud Foundation, Lisbon, Portugal (F.C.)); Knox S ( From Champalimaud Clinical Center-Champalimaud Foundation, Lisbon, Portugal (F.C.)); Matos E ( From Champalimaud Clinical Center-Champalimaud Foundation, Lisbon, Portugal (F.C.)); Meulemans B ( From Champalimaud Clinical Center-Champalimaud Foundation, Lisbon, Portugal (F.C.)); Neijenhuis PA ( From Champalimaud Clinical Center-Champalimaud Foundation, Lisbon, Portugal (F.C.)); Nitz U ( From Champalimaud Clinical Center-Champalimaud Foundation, Lisbon, Portugal (F.C.)); Passalacqua R ( From Champalimaud Clinical Center-Champalimaud Foundation, Lisbon, Portugal (F.C.)); Ravdin P ( From Champalimaud Clinical Center-Champalimaud Foundation, Lisbon, Portugal (F.C.)); Rubio IT ( From Champalimaud Clinical Center-Champalimaud Foundation, Lisbon, Portugal (F.C.)); Saghatchian M ( From Champalimaud Clinical Center-Champalimaud Foundation, Lisbon, Portugal (F.C.)); Smilde TJ ( From Champalimaud Clinical Center-Champalimaud Foundation, Lisbon, Portugal (F.C.)); Sotiriou C ( From Champalimaud Clinical Center-Champalimaud Foundation, Lisbon, Portugal (F.C.)); Stork L ( From Champalimaud Clinical Center-Champalimaud Foundation, Lisbon, Portugal (F.C.)); Straehle C ( From Champalimaud Clinical Center-Champalimaud Foundation, Lisbon, Portugal (F.C.)); Thomas G ( From Champalimaud Clinical Center-Champalimaud Foundation, Lisbon, Portugal (F.C.)); Thompson AM ( From Champalimaud Clinical Center-Champalimaud Foundation, Lisbon, Portugal (F.C.)); van der Hoeven JM ( From Champalimaud Clinical Center-Champalimaud Foundation, Lisbon, Portugal (F.C.)); Vuylsteke P ( From Champalimaud Clinical Center-Champalimaud Foundation, Lisbon, Portugal (F.C.)); Bernards R ( From Champalimaud Clinical Center-Champalimaud Foundation, Lisbon, Portugal (F.C.)); Tryfonidis K ( From Champalimaud Clinical Center-Champalimaud Foundation, Lisbon, Portugal (F.C.)); Rutgers E ( From Champalimaud Clinical Center-Champalimaud Foundation, Lisbon, Portugal (F.C.)); Piccart M ( From Champalimaud Clinical Center-Champalimaud Foundation, Lisbon, Portugal (F.C.)) |
| Abstract |
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 chemotherapy 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. (Funded by the European Commission Sixth Framework Program and others; ClinicalTrials.gov number, NCT00433589; EudraCT number, 2005-002625-31.). |
| ISSN |
00284793 |
| Issue Number |
8 |
| Volume Number |
375 |
| e-ISSN |
15334406 |
| Journal |
New England Journal of Medicine |
| Language |
English |
| Publisher |
Massachusetts Medical Society (United States) |
| Publisher Date |
2016-08-25 |
| Publisher Place |
United States |
| Access Restriction |
Subscribed |
| Subject Keyword |
Antineoplastic Agents Therapeutic Use Breast Neoplasms Genetics Chemotherapy, Adjuvant Gene Expression Profiling Genetic Predisposition To Disease Neoplasm Metastasis Prevention & Control Adult Aged Drug Therapy Mortality Surgery Disease-Free Survival Female Gene Expression Genetic Testing Humans Kaplan-Meier Estimate Mastectomy Middle Aged Neoplasm Staging Oligonucleotide Array Sequence Analysis Prospective Studies Risk Risk Assessment Clinical Trial, Phase III Journal Article Multicenter Study Randomized Controlled Trial Research Support, N.I.H., Extramural Research Support, Non-U.S. Gov't Medicine |
| Content Type |
Text |
| Resource Type |
Article |
| Subject |
Medicine |
