Reason for request

Extension of indication

Insufficient clinical benefit to justify its reimbursement, in combination with tamoxifen or with an aromatase inhibitor, for the adjuvant treatment of hormone-sensitive breast cancer in non-menopausal women at high risk of relapse, after chemotherapy.

 

  • DECAPEPTYL (triptorelin) LP 3 mg has been granted a marketing authorisation, in combination with tamoxifen or with an aromatase inhibitor, for the adjuvant treatment of hormone-sensitive breast cancer in non-menopausal women at high risk of relapse, after chemotherapy.

  • Triptorelin is a natural GnRH (gonadotropin releasing hormone) analogue that suppresses oestrogen synthesis by the ovaries. Suppression of ovarian function, combined with tamoxifen, causes increased toxicity relative to tamoxifen alone.

  • One study demonstrated the absence of benefit in terms of 5-year disease-free survival of ovarian function suppression (in particular by triptorelin) combined with tamoxifen compared to tamoxifen alone.

  • DECAPEPTYL LP 3 mg has no role in the current management strategy for early stage hormone-sensitive breast cancer in non-menopausal women, a strategy which is based on tamoxifen used alone.

 

 


Clinical Benefit

Insufficient

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Clinical Added Value

Not applicable

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