Prosigna Gene Signature to Assess Expected Benefit from Chemotherapy in Breast Cancer. Assessment of manufacturer’s submission

Breast cancer can be treated with chemotherapy, hormone therapy and radiation, or a combination of these to prevent the spread of cancer cells, after surgical removal of the tumor. When assessing whether a patient should be offered chemotherapy, information about prognosis is important. Patients at high risk of recurrence should be offered chemotherapy, while patients at low risk are not very likely to gain from such treatment, in which case side effects outweigh the benefits. The assessment of risk of recurrence is based on clinical findings, e.g. tumor size, lymph node involvement, and expression of certain receptors on the cancer cells. In this health technology assessment, we have considered a molecular profiling panel, Prosigna, which is meant to improve the ssessment of recurrence risk among women who have undergone surgical treatment for breast cancer. Our assessment is based on documentation submitted by the manufacturer of Prosigna, Nanostring.