ESTROTEP (fluoroestradiol (18F))

• Key points

Favourable opinion for reimbursement only in patients with metastatic, initially oestrogen receptor-positive breast cancer in early relapse following treatment with hormone therapy, when biopsy is deemed to be impossible and no hormone therapy lines can be envisaged.

Unfavourable opinion for reimbursement in the other MA situations.

Clinical benefit now low (previously it was insufficient) in the restricted perimeter defined above.

• What therapeutic improvement?

No clinical added value in the current diagnostic strategy in patients with metastatic, initially oestrogen receptor-positive breast cancer in early relapse following treatment with hormone therapy, when biopsy is deemed to be impossible and no hormone therapy lines can be envisaged.

• Role in the care pathway?

In primary breast cancer, standard imaging assessment is based on mammograms, potentially supplemented by ultrasound. The breast cancer diagnosis is confirmed by anatomical pathology testing of a biopsy specimen.

Staging is used to assess local, lymph node and remote infiltration. It is not routinely performed and should be reserved for patients presenting clinical warning signs. It is performed by a specialised care team and may include laboratory tests (tumour markers) or imaging exams (breast MRI, FDG-PET in the event of suspected recurrence).

The care pathway for metastatic breast cancer mainly depends on the histological characteristics of the tumour, prior treatments received and their tolerability, the site of the metastases, the time until relapse and predictive factors for treatment response (expression of hormone receptors, especially oestrogen, and/or HER2 receptors).

Currently, evaluation of the expression of oestrogen receptors is carried out by anatomical pathology testing after biopsy of the primary tumour and of a secondary lesion for tumours at the metastatic stage. It should be noted that in some situations, biopsy is judged to be impossible or not relevant.

Role of the medicinal product in the care pathway

ESTROTEP (18F-Fluoroestradiol) is a radiopharmaceutical medicinal product with a role in the diagnostic strategy for patients with metastatic, initially oestrogen receptor-positive breast cancer in early relapse following treatment with hormone therapy, when biopsy is deemed to be impossible and no hormone therapy lines can be envisaged.

ESTROTEP (18F-Fluoroestradiol) has no role in the other clinical situations of the MA.