8.3 Sex hormones and hormone antagonists in malignant disease

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8.3.1 Oestrogens

AMBER Diethylstilbestrol tablets 1mg

GREEN Ethinylestradiol tablets 1mg

8.3.2 Progestogens

GREEN Medroxyprogesterone acetate tablets 100mg, 400mg

GREEN Megestrol acetate tablets 160mg

GREEN Norethisterone tablets 5mg

For further information on the uses of Megestrol please see page 39 of guidelines <<link>>

8.3.4 Hormone antagonists

8.3.4.1 Breast Cancer

AMBER Anastrozole tablets 1mg

AMBER Exemestane tablets 25mg

AMBER Letrozole tablets 2.5mg

AMBER Tamoxifen tablets 10mg, 20mg

Tamoxifen use in prevention of breast cancer in women with family history of breast

cancer. [as per NICE guidance]

AMBER Tamoxifen 10mg.20mg tablets

Tamoxifen for treating postmenopausal women at high risk of breast cancer unless they have a past history or

may be at increased risk of thromboembolic disease or endometrial cancer.

See NICE TA164

AMBER Tamoxifen 10mg.20mg tablets

8.3.4.3 Gonadorelin analogues and gonadotrophin-releasing hormone antagonists

Metastatic cancer of the prostate usually responds to hormone treatments aimed at androgen depletion.

Gonadorelin analogues

Decapeptyl is the first line, preferential hormone for treatment of high-risk localised or locally advanced prostate cancer,

as an adjuvant to radical treatments for localised or locally advanced prostate cancer, and for metastatic prostate cancer.

To be given every 6 months,

Goserelin and leuprorelin are recommended for use within their licensed indications. with goserelin recommended as the

second line product. Any unlicensed uses (e.g. precocious puberty) should not be transferred to primary care prescribers:

prescribing should be retained by secondary care. There are two shared care protocols in place for the use of goserelin

(the preferred LHRH analogue). One covers the use in gynaecology, the other covers the use in oncology settings (breast &

prostate cancer), and they can be accessed online - click here to access them

First Line

AMBER Decapeptyl 22.5mg SR® powder for suspension for injection [Triptorelin]

For use in the treatment of high-risk localised or locally advanced prostate cancer, as an adjuvant to radical treatments

for localised or locally advanced prostate cancer, and for metastatic prostate cancer. To be given every 6 months.

Second Line

AMBER with SHARED CARE Goserelin injection 3.6mg, 10.8mg

Access the shared care guideline here

AMBER with SHARED CARE Leuprorelin injection 3.75mg, 11.25mg

(currently no shared care protocols exist for the use of leuprorelin locally)

Anti-androgens:-

Anti-androgens may inhibit tumour 'flare' which may occur after administration of gonadorelin analogues.

AMBER Generic Bicalutamide tablets 50mg, 150mg

AMBER Cyproterone acetate tablets 50mg, 100mg

AMBER Flutamide tablets 250mg

RED Abiraterone Acetate tablets 250mg

RED Enzalutamide 40mg capsules NICE TAG316 (The use of enzalutamide for treating metastatic hormone- relapsed prostate cancer previously treated with abiraterone is not covered by this guidance)

RED Enzalutamide 40mg capsules recommended as an option by NICE for treating metastatic hormone relapsed prostate cancer before chemotherapy is indicated. NICE TA377

RED Darolutamide NHS England Commissioned

NICE TA660 Darolutamide with androgen deprivation therapy [ADT] is recommended, within its marketing authorisation, as

for treating hormone-relapsed prostate cancer in adults at high risk of developing metastatic disease.

NICE TA903 Darolutamide with androgen deprivation therapy and docetaxel is recommended as an option for treating

hormone-sensitive metastatic prostate cancer in adults.

Darolutamide is only recommended if the company provides it according to the commercial arrangement.

RED Apalutamide NHS England Commissioned

NICE TA740 Apalutamide plus androgen deprivation therapy (ADT) is recommended, within its marketing authorisation,

as an option for treating hormone - relapsed non‑metastatic prostate cancer that is at high risk

of metastasising in adults. High risk is defined as a blood prostate-specific antigen (PSA) level that has

doubled in 10 months or less on continuous ADT. It is recommended only if the company provides apalutamide

according to the commercial arrangement.

NICE TA741 Apalutamide plus androgen deprivation therapy (ADT) is recommended as an option for treating

hormone-sensitive metastatic prostate cancer in adults, only if:

> docetaxel is not suitable

> the company provides apalutamide according to the commercial arrangement.

Gonadotrophin-releasing hormone antagonists

Degarelix is a gonadotrphin-releasing hormone antagonist used to treat advanced hormone dependent prostate cancer which

doesnot induce a testosterone surge or tumour 'flare'. Anti-androgen therapy is not required when Degarelix is used.

CAMET recommends its use ONLY where LHRH analogues or concomittant anti-androgens are contra-indicated.

Degarelix is recommended as an option for treating advanced hormone-dependent prostate cancer in people with spinal

metastases NICE TA404

AMBER Degarelix injection with diluent 80mg and 120mg

Click here to access a Prescribing Information Sheet for Degarelix (Firmagon®)

Degarelix for the treatment of adult male patients with advanced hormone dependent prostate cancer - patients without spinal metastases

To be recommended/initiated by specialist services.

Degarelix is recommended as an alternative to lutenising hormone releasing hormone agonists (LHRH) for treatment of adult male patients with advanced hormone-dependent prostate cancer without spinal metastases ONLY in the following circumstances:

> where LHRH analogues or concomitant anti-androgens are contra-indicated.

> in patients on androgen deprivation therapy who have a significant cardiac history/severe cardiac disease.

> very significant, symptomatic metastatic disease, and locally advanced disease to shrink the metastases.

> impending bladder outlet obstruction due to prostate cancer.

Degarelix Position Statement click here

AMBER Degarelix powder and solvent for solution for injection vials )Firmagon)

AMBER Relugolix–estradiol–norethisterone acetate [Ryeqo]

NICE TA832 Recommended, within its marketing authorisation, as an option for treating moderate to severe symptoms of uterine

fibroids in adults of reproductive age. ICB Commissioned

8.3.4.3 Somatostatin analogues

NHS England is responsible commissioner for acromegaly, cancer and congenital

hyperinsulinism. RED Traffic Light

RED Octreotide injection 50 microgram/1ml, 1mg/5ml

RED Octreotide depot injection 10mg, 20mg, 30mg

RED Lanreotide 30mg vial

60mg, 90mg, 120mg prefilled syringes

All other licensed indications are considered AMBER Traffic Light.

AMBER Octreotide injection 50microgram/1ml, 1mg/5ml

AMBER Octreotide depot injection 10mg, 20mg, 30mg

AMBER Lanreotide 30mg vial

60mg, 90mg, 120mg prefilled syringes

Lanreotide may be prescribed in line with its licensed indications only following

recommendation from a specialist centre. (NB - Any off license prescribing should not be

passed on to primary care prescribers)

UNLICENSED USE: [Blueteq form required]

RED Lanreotide [Somatuline Autogel, Somatuline LA®]

RED Octreotide [Sandostatin, sandostatin LAR®]

Unlicensed use in non-acute treatment of recurrent gastrointestinal bleeding disorders

(including angiodysplasia, small bowel dysplasia, gastric antral vascular ectasia,

haemorrhagic telangiectasia)

RED Lanreotide [Somatuline Autogel, Somatuline LA®]

RED Octreotide [Sandostatin, sandostatin LAR®]

Unlicensed use in Secretory Gastrointestinal Disorders (e.g. enterocutaneous fistula, high

output stoma and refractory diarrhoea)