1. Impact of 21-Gene Breast Cancer Assay on Treatment Decision for Patients with T1–T3, N0–N1, Estrogen Receptor-Positive/Human Epidermal Growth Receptor 2-Negative Breast Cancer: Final Results of the Prospective Multicenter ROXANE Study
- Author
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Dieci, M. V., Guarneri, V., Zustovich, F., Mion, M., Morandi, P., Bria, Emilio, Merlini, L., Bullian, P., Oliani, C., Gori, S., Giarratano, T., Orvieto, E., Griguolo, G., Michieletto, S., Saibene, T., Del Bianco, P., De Salvo, G. L., Conte, Pietro, Bria E. (ORCID:0000-0002-2333-704X), Dieci, M. V., Guarneri, V., Zustovich, F., Mion, M., Morandi, P., Bria, Emilio, Merlini, L., Bullian, P., Oliani, C., Gori, S., Giarratano, T., Orvieto, E., Griguolo, G., Michieletto, S., Saibene, T., Del Bianco, P., De Salvo, G. L., Conte, Pietro, and Bria E. (ORCID:0000-0002-2333-704X)
- Abstract
Background: The ROXANE Italian prospective study evaluated the impact of the 21-gene Recurrence Score (RS) results on adjuvant treatment decision for patients with early breast cancer. Materials and Methods: Nine centers participated. Physicians used the RS test whenever unsure about adjuvant treatment recommendation for patients with estrogen receptor-positive/human epidermal growth receptor 2-negative, T1–T3, N0–N1 early breast cancer. Pre-RS and post-RS treatment recommendations were collected. Results: A total of 251 patients were included. N0 patients (61%) showed higher grade (p <.001) and higher Ki67 (p =.001) and were more frequently progesterone receptor negative (p =.012) as compared with N1 patients. RS results were as follows: <11, n = 63 (25.1%); 11–25, n = 143 (57%); and ≥26, n = 45 (17.9%). Higher RS was found in N0 vs. N1 patients (p =.001) and in cases of G3 (p <.001) and higher Ki67 (p <.001). The rate of change in treatment decision was 30% (n = 75), mostly from chemotherapy (CT) plus hormone therapy (CT + HT) to hormone therapy (HT; 76%, n = 57/75). The proportion of patients recommended to CT + HT was significantly reduced from pre-RS to post-RS (52% to 36%, p <.0001). CT use reduction was more evident for N1 patients (55% to 27%) than for N0 patients (50% to 42%) and was observed only in cases of RS ≤17. Conclusion: Physicians predominantly used the 21-gene assay in N0 patients with a more aggressive biology or in N1 patients showing more indolent biology. In this selected patient population, the use of RS testing led to a 30% rate of change in treatment decision. In the N1 patient subgroup, the use of RS testing contributed to reduce CT use by more than half. Implications for Practice: This study shows that, even in a context in which physicians recommend a high proportion of patients to endocrine treatment alone before knowing the results of the Recurrence Score (RS) assay, the use of the RS test, whenever uncertainty regarding
- Published
- 2019