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Breast cancers expressing high levels of Ki67 are associated with poor outcomes. Oncotype DX test was designed for ER+/HER2− early-stage breast cancers to help adjuvant chemotherapy decision by providing a Recurrent Score (RS). RS measures the expression of 21 specific genes from tumor tissue, including  Ki67 . The primary aim of this study was to assess the agreement between Ki67 RNA  obtained with Oncotype DX RS and Ki67 IHC . Other objectives were to analyze the association between the event free survival (EFS) and the expression level of Ki67 RNA ; and association between RS and Ki67 RNA . Herein, we report a low agreement of 0.288 by Pearson correlation coefficient test between Ki67 IHC  and Ki67 RNA  in a cohort of 98 patients with early ER+/HER2− breast cancers. Moreover, Ki67 RNA  high  tumors were significantly associated with the occurrence of events ( p  = 0.03). On the other hand, we did not find any association between Ki67 IHC  and EFS ( p  = 0.26). We observed a low agreement between expression level of Ki67 RNA  and Ki67 protein labelling by IHC. Unlike Ki67 IHC  and independently of the RS, Ki67 RNA  could have a prognostic value. It would be interesting to better assess the prognosis and predictive value of Ki67 RNA  measured by qRT-PCR. The Ki67 RNA  in medical routine could be a good support in countries where Oncotype DX is not accessible.

Low correlation between Ki67 assessed by qRT-PCR in Oncotype Dx score and Ki67 assessed by Immunohistochemistry