The genomic expression test EndoPredict is a prognostic tool for identifying risk of local recurrence in postmenopausal endocrine receptor-positive, her2neu-negative breast cancer patients randomised within the prospective ABCSG 8 trial

F Fitzal, M Filipits, M Rudas, R Greil, O Dietze, H Samonigg, S Lax, W Herz, P Dubsky, R Bartsch, R Kronenwett, M Gnant, F Fitzal, M Filipits, M Rudas, R Greil, O Dietze, H Samonigg, S Lax, W Herz, P Dubsky, R Bartsch, R Kronenwett, M Gnant

Abstract

Background: The aim of this study was to examine whether EndoPredict (EP), a novel genomic expression test, is effective in predicting local recurrence (LR)-free survival (LRFS) following surgery for breast cancer in postmenopausal women. In addition, we examined whether EP may help tailor local therapy in these patients.

Methods: From January 1996 to June 2004, 3714 postmenopausal patients were randomly assigned to either tamoxifen or tamoxifen followed by anastrozole within the prospective ABCSG 8 trial. Using assay scores from EP, we classified breast tumour blocks as either low or high risk for recurrence.

Results: Data were gathered from 1324 patients. The median follow-up was 72.3 months and the cumulative incidence of LR was 2.6% (0.4% per year). The risk of LR over a 10-year period among patients with high-risk lesions (n=683) was significantly higher (LRFS=91%) when compared with patients with low-risk lesions (n=641) (10-year LRFS=97.5%) (HR: 1.31 (1.16-1.48) P<0.005). The groups that received breast conservation surgery (BCT) and mastectomy (MX) had similar LR rates (P=0.879). Radiotherapy (RT) after BCT significantly improved LRFS in the cohorts predicted by EP to be low-risk for LR (received RT: n=436, 10-year LRFS 99.8%; did not receive RT: n=63, 10-year LRFS 83.6%, P<0.005).

Conclusions: EndoPredict is an effective prognostic tool for predicting LRFS. Among postmenopausal, low-risk patients, EP does not appear to be useful for tailoring local therapy.

Figures

Figure 1
Figure 1
Kaplan–Meier curve of LRFS for patients undergoing BCT±RT or MX followed by either adjuvant tamoxifen or a tamoxifen/anastrozole sequence during 5 years. >50% of all patients had a high-risk cancer lesion measured by EP genetic expression score. EndoPredict high-risk lesions had a significant higher local recurrence rate (P=0.008).
Figure 2
Figure 2
Kaplan–Meier curve of LRFS only for patients with an EP high-risk cancer lesion undergoing BCT with RT or MX followed by either adjuvant tamoxifen or a tamoxifen/anastrozole sequence during 5 years. The increased LRFS in high-risk patients was not improved by MX.
Figure 3
Figure 3
Kaplan–Meier curve of LRFS for EP low-risk patients undergoing BCT±RT followed by either adjuvant tamoxifen or a tamoxifen/anastrozole sequence during 5 years. Radiotherapy improved LR even in low-risk patients significantly (P<0.001).

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