Abstract
BackgroundTo evaluate the effect of Recurrence Score® results (RS; Oncotype DX® multigene assay ODX) on treatment recommendations by Swiss multidisciplinary tumor boards (TB).MethodsSAKK 26/10 is a multicenter, prospective cohort study of early breast cancer patients: Eligibility: R0-resection, ≥10% ER+ malignant cells, HER2–, pN0/pN1a. Patients were stratified into low-risk (LR) and non-low-risk (NLR) groups based on involved nodes (0 vs 1–3) and five additional predefined risk factors. Recommendations were classified as hormonal therapy (HT) or chemotherapy plus HT (CT + HT). Investigators were blinded to the statistical analysis plan. A 5%/10% rate of recommendation change in LR/NLR groups, respectively, was assumed independently of RS (null hypotheses).ResultsTwo hundred twenty two evaluable patients from 18 centers had TB recommendations before and after consideration of the RS result. A recommendation change occurred in 45 patients (23/154 (15%, 95% CI 10–22%) in the LR group and 22/68 (32%, 95% CI 22–45%) in the NLR group). In both groups the null hypothesis could be rejected (both p < 0.001). Specifically, in the LR group, only 5/113 (4%, 95% CI 1–10%) with HT had a recommendation change to CT + HT after consideration of the RS, while 18/41 (44%, 95% CI 28–60%) of patients initially recommended CT + HT were subsequently recommended only HT. In the NLR group, 3/19 (16%, 95% CI 3–40%) patients were changed from HT to CT + HT, while 19/48 (40%, 95% CI 26–55%) were changed from CT + HT to HT.ConclusionThere was a significant impact of using the RS in the LR and the NLR group but only 4% of LR patients initially considered for HT had a recommendation change (RC); therefore these patients could forgo ODX testing. A RC was more likely for NLR patients considered for HT. Patients considered for HT + CT have the highest likelihood of a RC based on RS.
Highlights
To evaluate the effect of Recurrence Score® results (RS; Oncotype DX® multigene assay ODX) on treatment recommendations by Swiss multidisciplinary tumor boards (TB)
While initial trials in unselected women with early-stage ER-positive breast cancer failed to demonstrate a beneficial effect from adding chemotherapy to adjuvant endocrine therapy [1,2,3,4], it later became apparent that adjuvant chemo-endocrine therapy does reduce the recurrence rate compared with adjuvant endocrine therapy alone in certain selected populations
The NSABP B-20 [6] and SWOG 8814 [7] trials demonstrated that gene expression profiling is a useful tool for selecting patients who are most likely to benefit from adding chemotherapy to adjuvant treatment in patients with node-negative and node-positive breast cancers, respectively
Summary
To evaluate the effect of Recurrence Score® results (RS; Oncotype DX® multigene assay ODX) on treatment recommendations by Swiss multidisciplinary tumor boards (TB). The NSABP B-20 [6] and SWOG 8814 [7] trials demonstrated that gene expression profiling is a useful tool for selecting patients who are most likely to benefit from adding chemotherapy to adjuvant treatment in patients with node-negative and node-positive breast cancers, respectively. In both these trials, patients were stratified into three distinct groups following measurement of RNA expression using the ODX assay developed by Genomic Health Incorporated (GHI). These categories have been shown to correlate with the rate of distant recurrence in multiple studies in node negative [8,9,10,11] and node positive disease [7, 12] at 10 years as well as overall survival [8]
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