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8.3 Sex hormones and hormone antagonists in malignant disease

8.3 Sex hormones and hormone antagonists in malignant disease

8.3 Sex hormones and hormone antagonists in malignant disease


          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
 
           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 as it is a second line agent)

           

          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 
          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.
                       
          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 does not 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®)                            

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)