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2. 70-Gene Signature as an Aid to Treatment Decisions in Early-Stage Breast Cancer

Author

Fatima, Cardoso, Laura J, van't Veer, Jan, Bogaerts, Leen, Slaets, Giuseppe, Viale, Suzette, Delaloge, Jean-Yves, Pierga, Etienne, Brain, Sylvain, Causeret, Mauro, DeLorenzi, Annuska M, Glas, Vassilis, Golfinopoulos, Theodora, Goulioti, Susan, Knox, Erika, Matos, Bart, Meulemans, Peter A, Neijenhuis, Ulrike, Nitz, Rodolfo, Passalacqua, Peter, Ravdin, Isabel T, Rubio, Mahasti, Saghatchian, Tineke J, Smilde, Christos, Sotiriou, Lisette, Stork, Carolyn, Straehle, Geraldine, Thomas, Alastair M, Thompson, Jacobus M, van der Hoeven, Peter, Vuylsteke, René, Bernards, Konstantinos, Tryfonidis, Emiel, Rutgers, Martine, Piccart, Marc, Buyse, Commission of the European Communities, MINDACT Investigators, Benn, K., Bogaerts, J., Cardoso, F., Ciruelos, E., Corochan, S., Cuny, J., de la Pena, L., Delaloge, S., DeLorenzi, M., Dudek-Peric, A., Eekhout, I., Gluz, O., Golfinopoulos, V., Goulioti, T., Harbeck, N., Hilal, V., Knox, S., Lemonnier, J., Ławniczak, M., Marini, L., Matos, E., Morales, P., Murray, K., Nitz, U., Passalaqua, R., Piccart, M., Remmelzwaal, J., Rubio, I., Rutgers, E., Saghatchian, M., Slaets, L., Sotiriou, C., Straehle, C., Straley, M., Theron, N., Thompson, A., Tryfonidis, K., Todeschini, R., Urunkar, M., van 't Veer, L., Viale, G., Aalders, K., Bines, J., Bedard, P., Bozovic, I., Braga, S., Castaneda, C., Celebic, A., Colichi, C., Criscitiello, C., Dal Lago, L., Demonty, G., Drukker, C., Fei, F., Lia, M., Loi, S., Messina, C., Mook, S., Moulin, C., Sreseli, R., Therasse, P., Werutsky, G., Corachan, S., Wheeler, L., Dif, N., Rizzetto, G., Beauvois, M., Meirsman, L., Breyssens, H., Decker, N., Engelen, K., Akropovic, A., Harrison, J., Henot, F., Celis, M., De Jongh, B., Delmotte, I., Daubie, V., Goossens, R., Helsen, N., Hourt, L., Janssen, S., Soete, V., Vansevenant, K., Hermans, C., Hart, G., Brink, G., Floore, A., Sixt, B., and Buyse, M.

Subjects
0301 basic medicine, Oncology, medicine.medical_treatment, Gene Expression, Kaplan-Meier Estimate, law.invention, 0302 clinical medicine, MammaPrint, Randomized controlled trial, law, Prospective Studies, Neoplasm Metastasis, Prospective cohort study, Mastectomy, Oligonucleotide Array Sequence Analysis, medicine.diagnostic_test, 11 Medical And Health Sciences, General Medicine, Middle Aged, Chemotherapy, Adjuvant, 030220 oncology & carcinogenesis, Female, Adult, Aged, Antineoplastic Agents/therapeutic use, Breast Neoplasms/drug therapy, Breast Neoplasms/genetics, Breast Neoplasms/mortality, Breast Neoplasms/surgery, Disease-Free Survival, Gene Expression Profiling, Genetic Predisposition to Disease, Genetic Testing, Humans, Neoplasm Metastasis/prevention & control, Neoplasm Staging, Risk, Risk Assessment, Risk assessment, medicine.medical_specialty, Antineoplastic Agents, Breast Neoplasms, 03 medical and health sciences, Breast cancer, General & Internal Medicine, Internal medicine, medicine, Gynecology, business.industry, Gene signature, medicine.disease, Clinical trial, 030104 developmental biology, business
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.).

Published
2016
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