Therawis - Model therascreen PITX2 - Personalized Medicine

One in eight to ten women will get breast cancer during their lifetime. More than 460,000 women in Europe are newly diagnosed with breast cancer each year, with about 50% characterized as high-risk.

Therapy concepts for early breast cancer depend on prognostic risk classification, i.e. pending on the risk for disease recurrence patients will be treated more or less aggressively.

Prognostic risk classification by clinico-pathological assessment includes risk factors such as axillary lymph node status, tumor size, tumor grade, hormone-receptor status, patient age and Human Epidermal Growth Factor Receptor 2 (HER2)-status. While for patients at low and at high risk treatment recommendations are straightforward, the risk-benefit analysis for chemotherapy in patients at intermediate risk is challenging. Multigene signatures help to further stratify the intermediate risk group into low-risk (endocrine therapy, no systemic chemotherapy needed) and high-risk (indication for systemic chemotherapy) categories.

Patients with early breast cancer at high risk for disease recurrence require systemic chemotherapy. Anthracycline-based chemotherapy is considered standard of care according to national and international guidelines. As for any systemic chemotherapy, anthracyclines are associated with considerable side effects such as cardiac toxicity as well as secondary hematological malignancies (Azim et al., Annals of Oncology (2011) 22, 1939-1947).

Selection of the right patients for anthracycline-based chemotherapy vs. alternative chemotherapy (e.g. DC or P or CMF) is now supported by the PITX2-assay. The assay provides information to the treating physician, which patients are likely to benefit from anthracycline-based chemotherapy and which are not.

“Response prediction by PITX2 DNA-methylation provides valuable information on who has a high probability to benefit from anthracycline-based chemotherapy versus who should be considered for alternative chemotherapy regimen.”