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

被引：46

作者：

Davidson, J. A. ^{[1
]}

Cromwell, I. ^{[2
]}

Ellard, S. L. ^{[3
]}

Lohrisch, C. ^{[1
]}

Gelmon, K. A. ^{[1
]}

Shenkier, T. ^{[1
]}

Villa, D. ^{[1
]}

Lim, H. ^{[1
]}

Sun, S. ^{[1
]}

Taylor, S. ^{[3
]}

Taylor, M. ^{[3
]}

Czerkawski, B. ^{[3
]}

Hayes, M. ^{[1
]}

Ionescu, D. N. ^{[1
]}

Yoshizawa, C. ^{[4
]}

Chao, C. ^{[4
]}

Peacock, S. ^{[5
]}

Chia, K. ^{[1
]}

机构：

[1] British Columbia Canc Agcy, Vancouver, BC V5Z 4E6, Canada

[2] British Columbia Canc Res Ctr, Canadian Ctr Appl Res Canc Control, Vancouver, BC V5Z 1L3, Canada

[3] BCCA, Kelowna, BC, Canada

[4] Genom Hlth Inc, Redwood City, CA USA

[5] Univ British Columbia, Sch Populat & Publ Hlth, Vancouver, BC V5Z 1M9, Canada

来源：

EUROPEAN JOURNAL OF CANCER | 2013年 / 49卷 / 11期

关键词：

21-Gene Recurrence Score; ER plus breast cancer; Cost effective; Clinical utility; Chemotherapy; Hormonal therapy; DECISION-MAKING; GENE-EXPRESSION; CHEMOTHERAPY; THERAPY; WOMEN;

D O I：

10.1016/j.ejca.2013.03.009

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Purpose: The primary purpose of this study was to measure the impact of the 21-gene Recurrence Score (R) 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 naive' 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. (c) 2013 Published by Elsevier Ltd.

引用

页码：2469 / 2475

页数：7

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