Journal Article
. 2020 Mar;6().
doi: 10.1038/s41523-020-0148-0.

The Prosigna 50-gene profile and responsiveness to adjuvant anthracycline-based chemotherapy in high-risk breast cancer patients

Maj-Britt Jensen 1 Anne-Vibeke Lænkholm 2 Eva Balslev 3 Wesley Buckingham 4 Sean Ferree 4 Vesna Glavicic 5 Jeanette Dupont Jensen 6 Ann Søegaard Knoop 7 Henning T Mouridsen 1 Dorte Nielsen 8 Torsten O Nielsen 9 Bent Ejlertsen 10 
  • PMID: 32140564
  •     20 References
  •     1 citations


The DBCG89D trial randomized high-risk early breast cancer patients to adjuvant CMF (cyclophosphamide, methotrexate and fluorouracil) or CEF (cyclophosphamide, epirubicin and fluorouracil). Prosigna assays were performed by researchers with no access to clinical data. Time to distant recurrence (DR) was the primary endpoint, time to recurrence (TR) and overall survival (OS) secondary. Among the 980 Danish patients enrolled, Prosigna results were obtained in 686. Continuous ROR score was associated with DR for CMF (adjusted hazard ratio (HR) 1.20, 95% CI 1.09-1.33), and for CEF (HR 1.04, 95% CI 0.92-1.18), P interaction = 0.06. DR was significantly longer in CEF compared to CMF treated patients with Her2-enriched tumors (HR 0.58, 95% CI 0.38-0.86), but not in patients with luminal tumors. Heterogeneity of treatment effect was significant for TR and OS. In this prospective-retrospective analysis, patients with Her2-enriched breast cancer derived substantial benefit from anthracycline chemotherapy whereas anthracyclines are not an essential component of chemotherapy for patients with luminal subtypes. The benefit of CEF vs. CMF correlated with increasing ROR Score.

Keywords: Predictive markers; Randomized controlled trials.

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