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. 2008 May 15;14(10):2988-93.
doi: 10.1158/1078-0432.CCR-07-4723.

Analysis of the MammaPrint breast cancer assay in a predominantly postmenopausal cohort

Ben S Wittner  1 , Dennis C Sgroi, Paula D Ryan, Tako J Bruinsma, Annuska M Glas, Anitha Male, Sonika Dahiya, Karleen Habin, Rene Bernards, Daniel A Haber, Laura J Van't Veer, Sridhar Ramaswamy
Affiliations

Analysis of the MammaPrint breast cancer assay in a predominantly postmenopausal cohort

Ben S Wittner et al. Clin Cancer Res. .

Abstract

Purpose: Most node-negative breast cancer patients are older and postmenopausal and are increasingly being offered adjuvant chemotherapy despite their low overall risk of distant relapse. A molecular diagnostic test with high negative predictive value (NPV) for distant metastasis in this subgroup would spare many older breast cancer patients adjuvant treatment.

Experimental design: We determined the NPV and positive predictive value of the MammaPrint assay in breast cancer patients who were consecutively diagnosed and treated at the Massachusetts General Hospital between 1985 and 1997. Primary tumors from 100 patients with node-negative, invasive breast cancer (median age, 62.5 years; median follow-up, 11.3 years) were subjected to MammaPrint analysis and classified as being at either low or high risk for distant metastasis.

Results: The MammaPrint 70-gene signature displayed excellent NPV as in previous studies, correctly identifying 100% of women at low risk for distant metastases at 5 years. However, this assay had a lower positive predictive value (12% at 5 years) than previously observed.

Conclusions: The MammaPrint assay was originally designed to identify younger breast cancer patients at low risk for distant metastasis, who might consequently be spared systemic treatment. We show here that the same signature has a very high NPV for distant recurrence after adjuvant treatment in older breast cancer patients.

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Conflict of interest statement

Disclosure of Potential Conflicts of Interest

L.J.Van’t Veer, A.M. Glass, and T. Bruinsma are employed by Agendia BV. L.J. Van’t Veer has an ownership interest in MammaPrint. L.J.Van’tVeer and R. Bernards are named inventors on a patent to use microarray technology to ascertain breast cancer prognosis and hold equity interests in Agendia BV.

Figures

Fig. 1
Fig. 1
Overall clinical outcome of node-negative MGH versus NKI patients. Kaplan-Meier analysis of time to metastasis as a first event for the MGH and node-negative NKI cohorts. Green, MGH; black, NKI node negative; thin lines, 95% confidence interval (95% CI); black lines, previously published data (11).
Fig. 2
Fig. 2
Molecular classification of MGH patients. Kaplan-Meier analysis of time to metastasis as a first event for the MGH cohort based on classification with the 70-gene signature. Red, MammaPrint high risk; blue, MammaPrint low risk; thin lines, 95% CI.
Fig. 3
Fig. 3
Classification of MGH patients using Adjuvant! Online compared with MammaPrint. Adjuvant! Online – based relapse risk for individual patients classified as MammaPrint lowor high risk for (A) all 100 patients, (B) strictly considering 10-y distant metastasis-free survival. Solid square, patient with distant metastasis as a first event; circle, patient without distant metastasis as a first event; + in circle, patient identified as low risk by MammaPrint beyond Adjuvant! Online – based classification; horizontal line, threshold that simultaneously maximizes the number of patients classified as low risk while maintaining a NPV of 100%.
See this image and copyright information in PMC

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