252PD - Meta-Analysis of Prospective European Studies Assessing the Impact of Using The 21-Gene Recurrence Score Assay on Clinical Decision Making in Women With Er-Positive, Her2-Negative Early Stage Breast Cancer

Abstract

ABSTRACT Background The Oncotype DX® Recurrence Score is a validated assay to help inform the appropriate treatment of estrogen receptor-positive (ER+), early stage breast cancer. Adjuvant treatment traditions vary significantly among different countries. Prospective studies assessing the impact of the Oncotype DX test on adjuvant treatment decisions have been performed in several European countries. This is a meta-analysis of these studies. Methods Four prospective studies assessing the impact of using the Recurrence Score result on clinical decision making in patients with node negative and pN1 (mi) disease were identified. Node positive patients were excluded. The identified studies had a similar study design with consecutive patients and treatment recommendations before and after having the Recurrence Score results were recorded. In three of the studies, medical oncologists completed questionnaires regarding their confidence in their recommendation before and after knowing the patient's Recurrence Score result. The final results of the studies in Germany, Spain and the UK have been presented and final data from the French study will be presented at ASCO 2012. Results A total of 589 patients with node negative or pN1 (mi) ER pos HER2 negative early breast cancer were included in the four identified studies. Overall, 45% (range 36-52%) of patients in these studies were recommended chemo-endocrine and 55% endocrine treatment alone. After having the Recurrence Score result, 47% (range 38-60%) of patients recommended chemotherapy were changed to endocrine treatment alone and 17% (range 11-22%) of those recommended endocrine treatment alone were recommended chemo-endocrine treatment. There was a significant improvement in physician confidence in treatment recommendations when using the assay. Conclusion Using Oncotype DX® is associated with a significant change in treatment decisions and a reduction in chemotherapy use in studied European countries despite differences in therapeutic traditions. The consistency of the results from different countries underlines the tests utility. Disclosure J. Albanell: Participated advisory board (Genomic Health). S. Holt: Participated as a speaker, and in advisory board for Genomic Health. J. Gligorov: Has participated as speaker for Genomic Health. W. Eiermann: Participated as speaker and in advisory board for Genomic Health. C. Svedman: Employee and stocks in Genomic Health.