Abstract
The 21-gene test is a validated multi-gene diagnostic test that predicts chemotherapy (CT) benefit in oestrogen receptor positive (ER+), lymph node-negative (N0) breast cancer (BC) patients (pts). Ireland was the first public health care system to reimburse this test in Europe. Study objectives were to assess the impact of this test on decision-making and to analyse the economic impact of testing. Between October 2011 and February 2013, a national, retrospective, cross-sectional observational study of ER+, N0 BC pts tested with the 21-gene test was conducted. Surveyed breast medical oncologists, provided the assumption for the decision impact analysis that grade (G) 1 pts would not have received CT before testing and G2/3 pts would have received CT before testing. Descriptive statistical analyses were performed. 592 pts were identified; Low, intermediate and high recurrence score were identified in 53, 36 and 10 % pts, respectively. 384 (70 %) pts had G2, 129 (22 %) G3 and 76 (13 %) G1 tumours. Post testing, 345 pts (59 %) experienced a change in CT decision; 339 changed to hormone therapy alone and 6 advised to receive CT. 172 (30 %) pts received CT, 12 (3.9 %) of pts with low scores, 108 (50.9 %) of intermediate risk and 50 (90.9 %) of pts with high risk scores. Net reduction in CT use was 58 % and net savings achieved were €793,565. Since public reimbursement, the introduction of the 21-gene test has resulted in a significant reduction in chemotherapy administration and cost savings for the Irish public healthcare system.
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Acknowledgments
The data management staff of each cancer centre in Ireland contributed significantly to this work. The authors have disclosed that they have no financial or commercial interests with the manufacturers of any products discussed in this article or their competitors. This article was produced by employees of the Irish health service.
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This study was funded by Genomic health.
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The authors JW and MJK declare consultant roles for Roche and Genomic Health, respectively. The authors KV and OS declare funding from Pharmerit GmbH. All other authors declare that they have no conflict of interest.
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Smyth, L., Watson, G., Walsh, E.M. et al. Economic impact of 21-gene recurrence score testing on early-stage breast cancer in Ireland. Breast Cancer Res Treat 153, 573–582 (2015). https://doi.org/10.1007/s10549-015-3555-4
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DOI: https://doi.org/10.1007/s10549-015-3555-4