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

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Background
Options include second-line hormonal therapy,
chemotherapy with or without corticosteroids and
best supportive care, dependent on the symptoms,
site of relapse, performance status of the patient
and presence of other co-morbidities. 9 Best
supportive care can be provided with radiotherapy,
bisphosphonates, steroids and analgesics and is
the only option for patients who are too ill to
tolerate further active intervention. Treatment in
this setting is aimed at improvement of symptoms
and control rather than cure. 8
Current advice from the National Institute for
Health and Clinical Excellence (NICE) states that
chemotherapy should be considered and trials
of chemotherapy supported, and palliative
radiotherapy should also be considered as a
treatment option. 8 The use of chemotherapy in
mHRPC in the UK is widespread and likely to
increase (Mason M, Professor of Clinical Oncology,
Cardiff University, UK: personal communication,
2005).
Description of new intervention
Docetaxel is a member of a class of drugs known
as taxanes, derived from precursor extracted from
the needles of the European yew tree, Taxus
baccata. 14 Docetaxel is a mitotic inhibitor, which
acts by disrupting the microtubular network that is
essential for mitotic and interphase cellular
functions. It promotes the assembly of tubulin into
stable microtubules and inhibits microtubule
depolymerisation, causing inhibition of cell
division and cell death. 15
Docetaxel
The following section of the report summarises
the product characteristics for docetaxel, available
from the electronic Medicine Compendium 16
(www.medicines.org.uk/).
Docetaxel (Taxotere ® , Sanofi-Aventis) is available as
a 20- or 80-mg concentrate and solvent for solution
for infusion. Docetaxel is licensed for use in
combination with prednisone or prednisolone for
the treatment of patients with mHRPC. Prednisone
is not used in the UK, but it is reasonable to use
docetaxel plus prednisone data in this review of
docetaxel plus prednisolone. Docetaxel is
administered as a 1-hour infusion once every
3 weeks. The recommended dose is 75 mg/m 2 ,
whereas prednisone/prednisolone should be
administered continuously, at a dose of 5 mg orally
twice per day. Safety and efficacy have not been
established for children, and there are no special
instructions for the use of docetaxel in the elderly.
New guidelines prepared by the British
Association of Urological Surgeons (BAUS)
propose considering the use of docetaxel for
symptomatic patients who are fit for
chemotherapy. 17 It is acknowledged that the
clinical management of mHRPC is multimodal
rather than sequential and at any given time a
patient may receive a combination of palliative
treatments.
Contraindications
● Hypersensitivity to the active substance or any
component of the medicinal product
● baseline neutrophil count of