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Docetaxel with prednisone or prednisolone for the treatment of ...

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6<br />

Background<br />

possible benefit from such <strong>treatment</strong> warrants<br />

<strong>the</strong> risk <strong>of</strong> fur<strong>the</strong>r medullary suppression.<br />

● No data are available in patients <strong>with</strong> renal<br />

impairment.<br />

● No data are available in patients treated <strong>with</strong><br />

mitoxantrone concomitantly <strong>with</strong> o<strong>the</strong>r<br />

medications.<br />

Adverse events<br />

● No non-haematological adverse events <strong>of</strong><br />

grade 3 <strong>or</strong> 4 were seen in m<strong>or</strong>e than 5% <strong>of</strong><br />

patients.<br />

● Severe neutropenia is very common, as are mild<br />

to moderate nausea and vomiting.<br />

● Congestive heart failure, tachycardia,<br />

arrythmias, chest pain and asymptomatic<br />

decreases in left ventricular ejection fraction<br />

have been rep<strong>or</strong>ted.<br />

Estramustine<br />

The following section <strong>of</strong> <strong>the</strong> rep<strong>or</strong>t summarises<br />

<strong>the</strong> product characteristics f<strong>or</strong> estramustine<br />

(Estracyt ® , Pfizer), available from <strong>the</strong> Electronic<br />

Medicines Compendium 22 (www.medicines.<strong>or</strong>g.uk/).<br />

Estramustine is a compound consisting <strong>of</strong><br />

oestradiol and nitrogen mustard that has mild<br />

anti-microtubule actions. It has a dual mode <strong>of</strong><br />

action; it acts as an anti-mitotic agent and exerts<br />

an anti-gonadotrophic effect. Estramustine also<br />

binds to a protein present at <strong>the</strong> tumour site,<br />

resulting in an accumulation <strong>of</strong> <strong>the</strong> drug at <strong>the</strong><br />

target site.<br />

Estramustine is available in 140-mg gelatine<br />

capsules. Estramustine is licensed in <strong>the</strong> UK f<strong>or</strong><br />

<strong>the</strong> <strong>treatment</strong> <strong>of</strong> carcinoma <strong>of</strong> <strong>the</strong> prostate,<br />

especially in cases unresponsive to, <strong>or</strong> relapsing<br />

after, <strong>treatment</strong> <strong>with</strong> h<strong>or</strong>mones. The dosage <strong>of</strong><br />

estramustine can range from one to 10 capsules<br />

per day, <strong>with</strong> standard starting doses <strong>of</strong> four to six<br />

capsules per day. Each capsule should be taken<br />

<strong>or</strong>ally, not less than 1 hour bef<strong>or</strong>e <strong>or</strong> 2 hours after<br />

meals. The capsules should not be taken <strong>with</strong> milk<br />

<strong>or</strong> milk products. Estramustine should not be<br />

administered to children.<br />

Contraindications<br />

● Hypersensitivity to oestradiol <strong>or</strong> nitrogen<br />

mustard<br />

● children<br />

● peptic ulceration, severe liver dysfunction <strong>or</strong><br />

myocardial insufficiency<br />

Special warnings and precautions f<strong>or</strong> use<br />

● Caution should be exercised if using in patients<br />

<strong>with</strong> moderate to severe bone marrow<br />

depression, thrombophlebitis, thrombosis,<br />

thromboembolic dis<strong>or</strong>ders, cardiovascular<br />

disease, c<strong>or</strong>onary artery disease and congestive<br />

heart failure.<br />

● Caution should also be exercised in patients<br />

<strong>with</strong> diabetes, hypertension, epilepsy, hepatic<br />

and renal impairment and diseases associated<br />

<strong>with</strong> hypercalcaemia.<br />

● Blood counts, liver function tests and serum<br />

calcium in hypercalcaemia should be perf<strong>or</strong>med<br />

at regular intervals and calcium levels closely<br />

monit<strong>or</strong>ed.<br />

● Milk, milk products <strong>or</strong> any drugs containing<br />

calcium may impair <strong>the</strong> abs<strong>or</strong>ption <strong>of</strong><br />

estramustine and should not be taken<br />

concomitantly.<br />

Adverse events<br />

● The most common adverse events are<br />

gynaecomastia and impotence, anaemia,<br />

granulocytopenia, nausea and vomiting<br />

(particularly during <strong>the</strong> first 2 weeks <strong>of</strong><br />

<strong>treatment</strong>) and fluid retention and oedema.<br />

● The most serious adverse events are<br />

thromboembolism, ischaemic heart disease and<br />

congestive heart failure.<br />

● Therapy <strong>with</strong> estramustine should be<br />

discontinued immediately should angioneurotic<br />

oedema occur.

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