A prospective clinical utility and pharmacoeconomic study of the impact of the 21-gene Recurrence Score® assay in oestrogen receptor positive node negative breast cancer

Abstract Purpose The primary purpose of this study was to measure the impact of the 21-gene Recurrence Score® result on systemic treatment recommendations and to perform a prospective health economic analysis in stage I–II, node-negative, oestrogen receptor positive (ER+) breast cancer. Methods Cons...

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Bibliographic Details
Published in:European journal of cancer (1990) 2013-07, Vol.49 (11), p.2469-2475
Main Authors: Davidson, J.A, Cromwell, I, Ellard, S.L, Lohrisch, C, Gelmon, K.A, Shenkier, T, Villa, D, Lim, H, Sun, S, Taylor, S, Taylor, M, Czerkawski, B, Hayes, M, Ionescu, D.N, Yoshizawa, C, Chao, C, Peacock, S, Chia, S.K
Format: Article
Language:English
Subjects:
21-Gene Recurrence Score
Adult
Aged
Biological and medical sciences
Breast Neoplasms - diagnosis
Breast Neoplasms - drug therapy
Breast Neoplasms - economics
Breast Neoplasms - genetics
Chemotherapy
Clinical utility
Cost effective
Cost-Benefit Analysis
Economics, Pharmaceutical
ER+ breast cancer
Female
Hematology, Oncology and Palliative Medicine
Hormonal therapy
Humans
Medical sciences
Middle Aged
Multiple tumors. Solid tumors. Tumors in childhood (general aspects)
Neoplasm Staging
Pharmacology. Drug treatments
Prospective Studies
Receptors, Estrogen - biosynthesis
Risk Assessment
Risk Factors
Transcriptome
Tumors
Young Adult
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Summary:Abstract Purpose The primary purpose of this study was to measure the impact of the 21-gene Recurrence Score® result on systemic treatment recommendations and to perform a prospective health economic analysis in stage I–II, node-negative, oestrogen receptor positive (ER+) breast cancer. Methods Consenting patients with ER+ node negative invasive breast cancer and their treating medial oncologists were asked to complete questionnaires about treatment preferences, level of confidence in those preferences and a decisional conflict scale (patients only) after a discussion of their diagnosis and risk without knowledge of the Recurrence Score. At a subsequent visit, the assay result and final treatment recommendations were discussed prior to both parties completing a second set of questionnaires. A Markov health state transition model was constructed, simulating the costs and outcomes experienced by a hypothetical ‘assay naïve’ population and an ‘assay informed’ population. Results One hundred and fifty-six patients across two cancer centres were enrolled. Of the 150 for whom successful assay results were obtained, physicians changed their chemotherapy recommendations in 45 cases (30%; 95% confidence interval (CI) 22.8–38.0%); either to add (10%; 95% CI 5.7–16.0%) or omit (20%; 95% CI 13.9–27.3%) adjuvant chemotherapy. There was an overall significant improvement in physician confidence post-assay ( p < 0.001). Patient decisional conflict also significantly decreased following the assay ( p < 0.001). The simulation model found an incremental cost-effectiveness ratio of Canadian Dollars (CAD) $6630/quality-adjusted life years (QALY). Conclusion Within the context of a publicly funded health care system, the Recurrence Score assay significantly affects adjuvant treatment recommendations and is cost effective in ER+ node negative breast cancer.
ISSN:0959-8049
1879-0852
DOI:10.1016/j.ejca.2013.03.009