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Impact of a 21-gene RT-PCR assay on treatment decisions in early-stage breast cancer
An economic analysis based on prognostic and predictive validation studies†
Article first published online: 20 FEB 2007
Copyright © 2007 American Cancer Society
Volume 109, Issue 6, pages 1011–1018, 15 March 2007
How to Cite
Lyman, G. H., Cosler, L. E., Kuderer, N. M. and Hornberger, J. (2007), Impact of a 21-gene RT-PCR assay on treatment decisions in early-stage breast cancer. Cancer, 109: 1011–1018. doi: 10.1002/cncr.22506
Presented, in part, at the 42nd Annual Meeting of the American Society of Clinical Oncology, June 2–5, 2006, Atlanta, GA.
- Issue published online: 7 MAR 2007
- Article first published online: 20 FEB 2007
- Manuscript Accepted: 14 NOV 2006
- Manuscript Revised: 13 NOV 2006
- Manuscript Received: 29 SEP 2006
- breast cancer;
- 21-gene RT-PCR;
- lymph node-negative;
- estrogen receptor-positive;
- adjuvant chemotherapy;
- economic analysis;
The prognostic accuracy for distant recurrence-free survival using a 21-gene reverse-transcriptase polymerase chain reaction (RT-PCR) assay underwent validation in 668 lymph node-negative, estrogen receptor-positive women with early-stage breast cancer receiving tamoxifen on National Surgical Adjuvant Breast Program (NSABP) B-14. The predictive accuracy for treatment efficacy also underwent validation in 651 patients randomized on NSABP B-20 and 645 patients on NSABP B-14.
Patients were classified as high (recurrence score [RS] ≥ 31), intermediate (RS 18–30), or low (RS < 18) risk for distant recurrence at 10 years. Cost-effectiveness ratios were estimated for RS-guided treatment compared with either tamoxifen alone or the combined chemotherapy and tamoxifen.
Distant recurrence was reported in RS low-risk, intermediate-risk, and high-risk patients at 10 years in 3.7%, 17.8%, and 38.3% receiving tamoxifen alone and 5.0%, 10.1%, and 11.1% receiving the chemotherapy and tamoxifen. RS-guided therapy is associated with a gain in individual life expectancy of 2.2 years compared with tamoxifen alone, whereas it is associated with similar life expectancy to that seen with the chemotherapy and tamoxifen strategy. RS-guided therapy is estimated to provide a net cost savings of $2256 compared with chemotherapy and tamoxifen with an incremental cost-effectiveness ratio of $1944 per life year saved compared with tamoxifen alone.
Treatment decisions based on RS-guided therapy compared with tamoxifen alone are associated with greater efficacy with acceptable cost-effectiveness ratios, and associated with similar efficacy and lower cost compared with chemotherapy and tamoxifen for patients with lymph node-negative, estrogen receptor-positive early-stage breast cancer. Cancer 2007 © 2007 American Cancer Society.