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

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 adjuvant treatment recommendation is present, significantly contributes in further reducing the use of chemotherapy, especially for N1 patients.

Using Breast Cancer Gene Expression Signatures in Clinical Practice: Unsolved Issues, Ongoing Trials and Future Perspectives

“…A pooled analysis of four prospective European studies assessing the impact of using the OncotypeDX © recurrence score in node-negative HR+/HER2− early breast cancer demonstrated that chemotherapy recommendation rate decreased from 55% to 34% [ 111 , 112 ]. Similar results were reported in node-negative [ 113 ] but also node-positive early breast cancer [ 114 , 115 , 116 ]. The Prosigna © PAM50 [ 117 , 118 , 119 , 120 ] and EndoPredict © [ 121 ] assays also demonstrated a 20–35% decreasing of chemotherapy indications in HR+/HER2− early breast cancer.…”

The use of genomic tests in patients with breast cancer in Lombardy: a successful healthcare model

“…The results showed that in 50% of the patients for whom chemotherapy was initially recommended according to traditional clinical practice, the Oncotype DX RS was low, thus allowing delivery of hormone therapy only; on the other hand, in only 4% of the patients for whom hormone therapy alone was originally recommended (about two-thirds of the patients in the study), the Oncotype DX test RS was high, providing evidence of a clinical benefit from adding chemotherapy. The results of the BONDX study, 15 in line with the literature and in particular with a previous Italian study (ROXANE study), 16 confirm that the multigene tests bear clinical utility, improve quality of life, and are cost-effective for the healthcare system.…”

“…Patients with RS results <11 were treated with hormone therapy only, while patients with high RS results (RS >25) received chemotherapy associated with hormone therapy. Patients with intermediate RS results (11)(12)(13)(14)(15)(16)(17)(18)(19)(20)(21)(22)(23)(24)(25) were randomized to hormone therapy only or chemotherapy associated with hormone therapy. The results demonstrated (with a level of evidence 1A) that patients with RS results 11-25 do not benefit from the addition of chemotherapy to hormone therapy and can be safely spared its toxicities.…”

Invasive Ductal Breast Cancer with Osteoclast-Like Giant Cells: A Case Report Based on the Gene Expression Profile for Changes in Management

“…Among the 121 BC patients, candidates for exclusive hormone therapy without the Oncotype Dx, 18 (15%) patients obtained an RS that referred to chemotherapy treatment followed by hormone therapy. The percentage of patients initially recommended for hormone therapy alone for whom the recommendation changed to chemotherapy plus hormone therapy was low (7%) [ 40 ].…”