ZEULIDE (leuproréline)

Key points

Favourable opinion for maintenance of reimbursement in:

•  the palliative treatment of advanced hormone-dependent prostate cancer;
• the preoperative management of uterine fibroids;
• the management of endometriosis, as a single treatment or as an adjunct to surgery;
• the treatment of premenopausal women with advanced breast cancer suitable for hormonal manipulation;
• the treatment of children with a diagnosis of central precocious puberty.

Unfavourable opinion for reimbursement in the other MA situations.   

• What therapeutic improvement?

No clinical added value in the therapeutic strategy compared to the other medicinal products containing leuprorelin at the same strengths. 

 Role in the care pathway?

Advanced hormone-dependent prostate cancer

At the locally advanced stage, androgen deprivation hormone therapy using a GnRH agonist or antagonist combined with adjuvant external radiotherapy for 2 to 3 years (neoadjuvant use may also be considered for 4 to 6 months) is recommended.

Uterine fibroids

The management of symptomatic fibroids is predominantly surgical (hysterectomy or myomectomy). However, some women do not want invasive surgery and wish to preserve their uterus and their fertility. In these cases, medical treatment prior to surgery can make it possible to perform less invasive surgical procedures.

No currently validated medical treatment for fibroid-related symptoms is capable of making fibroids disappear. Therefore in the event of asymptomatic fibroids, there is no point envisaging medical treatment. In the presence of symptomatic fibroids (pain or bleeding), the objective of medical therapy is solely to treat symptoms.

The progestogen-containing medicinal products indicated in the management of fibroid-related functional bleeding and/or menorrhagia are COLPRONE (medrogestone), LUTENYL (nomegestrol), LUTERAN (chlormadinone) and SURGESTONE (promegestone).

GnRH analogues have an MA and are used in the preoperative management of uterine fibroids to reduce their size and/or associated bleeding.

Endometriosis

The first-line hormonal treatments are combined oestrogen and progestogen contraception.

The second-line hormonal treatments are micro-progestogen contraception (desogestrel, etonogestrel, dienogest) or GnRH analogues combined with an oestrogen.

There is no point prescribing GnRH analogues postoperatively with the sole objective of preventing the recurrence of endometriosis.

Treatment of breast cancer

The therapeutic strategy 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 (HR) and/or HER2 receptors). In the absence of short-term life-threatening symptomatic visceral involvement, the therapeutic strategy is based on hormone therapy. The choice of hormone therapy depends on the menopausal status and prior hormone therapies.

In pre-/perimenopausal patients, an LHRH agonist (goserelin or leuprorelin) should be combined with these hormone therapies.

Preservation of ovarian function

There are several methods for the preservation of female fertility. The limitations and the choice of the most suitable method depend on numerous factors: preservation of ova, embryos, ovarian tissue.

Treatment of central precocious puberty

In situations in which progressive central precocious puberty has been confirmed, the treatment of central precocious puberty is primarily based on the use of GnRH agonists. Depot forms, with monthly or quarterly injections, are used. The short, medium and long-term safety of these treatments must be monitored.

For slow-progressing forms of precocious puberty, treatment with GnRH agonists is not indicated since the course is either towards complete regression of puberty signs for the youngest patients or a slow progression of puberty.

Role of ZEULIDE (leuprorelin acetate) in the care pathway:

ZEULIDE (leuprorelin acetate) is an additional treatment option in the MA indications, like the other medicinal products at the same strengths already available only in:

• the palliative treatment of advanced hormone-dependent prostate cancer;
• the preoperative management of uterine fibroids;
• the management of endometriosis, as a single treatment or as an adjunct to surgery;
• the treatment of premenopausal women with advanced breast cancer suitable for hormonal manipulation;
• the treatment of children with a diagnosis of central precocious puberty.