A simple immunohistochemical bio-profile incorporating Bcl2 curbs those cases of invasive breast carcinoma for which an Oncotype Dx characterization is needed

Aim Our goal has been to evaluate the importance that the incorporation of Bcl2 in the ER/PGR/ Her2/Ki67 bio-profile can have as predictor of the Oncotype Dx categories. Material and methods 156 consecutive cases of HR+/Her2- pN0/1 primary breast carcinoma were sent to the Oncotype Dx test. Immunohistochemical determination of Bcl2/ER/PGR/Ki67/Her2 expression was evaluated for each case. After the selection of the appropriate cut-off values for PGR and Ki67, explorative as well as confirmative statistical analyses were performed to build and validate predictive risk-of-recurrence immunohistochemical only bio-profiles. Results The predictive capacity of these immunohistochemical profiles was compared with both traditional and TAILORx Oncotype Dx risk class classification. This comparison showed that immunohistochemical bio-profiles select those cases not associated with high risk-of-recurrence of disease (luminal-A/B and luminal A/B Bcl2) and those that are instead at high risk and therefore worthy of chemotherapy (luminal-B ki67 and luminal-B Bcl2/Ki67), strongly suggesting to only submit PGR-positive/Bcl2-Ki67 altered cases to Oncotype Dx, thus reducing the number of cases to be tested. Conclusions Our results indicate that the addition of Bcl2 to an immunohistochemical bio-profile definitely improves its predictive capacity to correctly select which cases to send to the Oncotype Dx test. We have also suggested that institutions with a significant number of breast carcinomas sent to the Oncotype Dx test can use these latter to derive their own PGR and Ki67 cutoff values, overcoming the drawbacks of sharing common inter-laboratory values. Validation of these bio-profiles as predictors of the Oncotype Dx categories is ongoing in a prospective series of new cases.