After surgery to remove breast cancer, the oncologist will assess whether the patient should undergo subsequent chemotherapy or not. This evaluation normally takes place on the basis of clinical-pathological factors (lymph node status, tumour size and stage, age of the patient, etc.) and immunohistochemical factors (cell proliferation markers, expression of hormonal receptors, etc.).
The Prosigna™ prognostic testing kit offers the oncologist additional useful information which can be useful for identifying patients for whom chemotherapy can be avoided. Prosigna™ is the only test available on the national territory, therefore it does not require samples to be sent abroad. It uses genetic expression analysis to detect patients with tumours having a low chance of recurrence in the 10 years following surgery. In this way, it offers additional information to be added to the clinical-pathological and immunohistochemical information, which is useful for physicians to identify patients who can avoid post-surgical chemotherapy within a context of personalized therapeutic choices. The NEMESI (BMC Cancer, 2012) clinical trial, conducted by Italian researchers, has highlighted how it was possible to avoid chemotherapy in 25% of cases, and thus its side effects were also able to be avoided.
Prosigna™ is a diagnostic procedure (CE/IVD – FDA) which uses the NanoString nCounter ® DX analysis method to assess the expression profile of a group consisting of 50 genes involved in the progression of breast cancer.
It is the only test that allows us to obtain a genetic classification of breast carcinomas and at the same time to assess the risk category for 10-year recurrence in women who have undergone surgery for breast cancer.
The risk of recurrence is expressed on a scale of 0 to 100, making it possible to define three risk categories (low, intermediate and high risk). The genetic classification of cancer permits a more accurate indication of how to choose the best treatment option for each patient as well as information regarding the individual prognosis.
In order to undergo the Prosigna™ test, you will need to be referred by an oncologist. Since the test cannot be provided as part of the services under the National Healthcare System, a request on the doctor’s headed paper is sufficient.
On the day set for the test, you will need to go to the admission service of the Campus Bio-Medico University Hospital (floor -1, desk 1, direct access without reservation number) with the following material:
- Histological sample. If the tumour removal surgery has taken place at the Campus Bio-Medico University Hospital, the histological sample will already be kept at our laboratory. Otherwise, the patient will need to obtain the histological sample before the day of the test, submitting the following request to the hospital facilities where they were originally treated:
- Paraffine-embedded tissue block of the invasive carcinoma (the sample will be returned after the test has been carried out);
- Alternatively, prepare at least 6 10-micron thick histological sections from the tissue block, each on a standard histology slide (non-polarized and without adhesive), using sterile distilled water in disposable containers (e.g. Petri dish) for collection. From a paraffin-embedded tissue block, prepare sections of the infiltrating and primary carcinoma, in which the neoplasm is predominant over healthy tissue. Provide a corresponding haematoxylin and eosin stain section.
- Certified copy of the Pathology report of the material submitted
- Medical referral for the Prosigna™ test to be carried out (a request on the doctor’s headed paper, signed by a physician, with the telephone number of the latter)
Test results will be available within 15 working days from the day of the test being carried out.
Prosigna™ is a prognostic test certified by Food and Drug Administration (FDA approved) and European Union (CE-IVD), which will not be reimbursed by the National Healthcare System. The price of the test is 3,000 euros, which has to be paid by the patient himself.