FIRMAGON (dégarélix) - Cancer de la prostate

Key points

Favourable opinion for reimbursement in:

• Treatment of high-risk localised or locally advanced hormone dependent prostate cancer in combination with radiotherapy.
• Neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced hormone dependent              prostate cancer.

What therapeutic improvement?

No clinical added value in the therapeutic strategy.

Role in the care pathway?

The current guidelines for the treatment of advanced hormone-dependent (locally advanced or metastatic) or high-risk localised prostate cancer recommend:

• at the high-risk localised or locally advanced stage: androgen deprivation hormone therapy using a GnRH agonist or antagonist combined with adjuvant external radiotherapy for 2 to 3 years (neo-adjuvant use may also be considered for 4 to 6 months).

It should be noted that the care pathway has recently evolved, with, in particular, the integration of second-generation androgen receptor antagonists since 2019, in combination with androgen deprivation therapy (ADT) in patients with non-metastatic castration-resistant prostate cancer (nmCRPC): apalutamide (ERLEADA), enzalutamide (XTANDI) or darolutamide (NUBEQA), in high-risk patients (PSA doubling time ≤ 10 months).

• at the metastatic stage:
  • In hormone-sensitive patients (mHSPC), ADT should be used in combination with second-generation androgen receptor antagonists [apalutamide (ERLEADA)] or enzalutamide (XTANDI) or abiraterone acetate (ZYTIGA) in combination with prednisone or prednisolone in newly diagnosed high-risk patients, or with docetaxel in patients eligible for chemotherapy and who cannot receive the previously mentioned treatments. External radiotherapy may potentially be used for low-volume tumours.
  • In castration-resistant patients (mCRPC), castration should be maintained and chemotherapy (docetaxel, cabazitaxel in patients previously treated with docetaxel) or second-generation hormone therapy [abiraterone acetate (ZYTIGA), enzalutamide (XTANDI)] may be proposed. It should be noted that radium 223 (XOFIGO) only has an MA in the event of bone metastases after two prior treatment lines.

Androgen deprivation therapy as neo-adjuvant or adjuvant treatment along with external radiotherapy in locally advanced or high-risk localised tumours, and at metastatic stages, includes two treatment classes, a GnRH antagonist, FIRMAGON (degarelix), and GnRH agonists (groserelin, triptorelin, leuprorelin). In the event of treatment with a GnRH agonist alone, temporary hypertestosteronaemia (flare up effect) may be observed. This effect is not observed with degarelix. A first-generation antiandrogen (bicalutamide, nilutamide, flutamide) generally used to be combined with the GnRH agonist for a short period of time in order to prevent the clinical consequences of serum testosterone peaks. Since the arrival of second-generation androgen receptor antagonists in combination with androgen deprivation therapy and the evolution of the care pathway, the use of first-generation antiandrogens has been limited (only in the context of complete androgen blockade).

Role of FIRMAGON (degarelix) in the care pathway

FIRMAGON (degarelix) is an alternative to GnRH agonists as a first-line treatment in the care pathway for hormone-dependent prostate cancer at high-risk localised and locally advanced stages as neo-adjuvant treatment prior to radiotherapy or in combination with radiotherapy. At present, the recommended duration of androgen deprivation hormone therapy using a GnRH agonist or antagonist combined with adjuvant external radiotherapy is 2 to 3 years (neoadjuvant use may also be considered for 4 to 6 months).