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Prostate metastatic DOCEtaxel three weekly and prednisolone

Check for clinical trials in this patient group. Link to Australian Clinical Trials website

The anticancer drug(s) in this protocol have been updated with the ADDIKD guideline recommendations (if applicable). Recommendations may differ from other protocols which have not been updated. For further information refer to the dedicated eviQ ADDIKD guideline webpage.

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Cycle 1 and further cycles

Drug Dose Route Day
DOCEtaxel 75 mg/m2 * IV infusion 1
Prednisolone 10 mg ONCE a day ** PO 1 to 21

* For elderly or Asian patients, consider reducing initial docetaxel dose to 60 mg/m2 or using ID 2028 Prostate metastatic DOCEtaxel two weekly and prednisolone, as per reference committee consensus.

** Prednisolone can be given as 5 mg TWICE a day. It is given continuously during all cycles of treatment. This is often tapered off slowly over a period of 1 month after completion of chemotherapy at the discretion of the medical officer. Note that in castration-sensitive patients, prednisolone was not required. Clinicians may wish to consider minimising use of ongoing prednisolone in castration-resistant patients.

Frequency:
21 days 
Cycles:
Continuous until disease progression or unacceptable toxicity; up to 10 cycles
Notes:

Patients had their luteinising hormone-releasing hormone (LHRH) agonist therapy continued.

The study from the key evidencer was performed in fit patients with good performance status and the data is only relevant for such patients. Patients who have had pelvic radiation therapy, pre treatment with radio-isotopes may be more suited to consider dose reductions or a weekly regimen.

Drug status:

Docetaxel is on the PBS general schedule

Cost:
~ $80 per cycle "How this cost is calculated"

The cost displayed on the protocol is intended as rudimentary guide only for the Australian context.

The cost includes anti-cancer drugs only (not antiemetics, supportive medications or consumables), unless otherwise indicated.

Drug unit costs are taken directly from the Pharmaceutical Benefits Scheme (PBS) website (www.pbs.gov.au), MIMS Online and other sources. These costs are reviewed and updated on eviQ at 6 monthly intervals.

Where there are differing unit costs based on vial sizes and tablet strengths, the mean unit cost is used. The cost of oral continuous therapy is based on a 28 day month.

The protocol cost is derived from drug dose calculations based upon a default body surface area (BSA) of 1.8 m2; weight of 75 kg; and creatinine clearance of 75 mL/min.

One off loading doses and ongoing maintenance doses are not included in protocol cost calculations.

The cost displayed is the actual drug cost and does not necessarily reflect the cost incurred by the patient as many anti-cancer drugs are reimbursed on the PBS.

The supportive therapies (e.g. antiemetics, premedications, etc.), infusion times, diluents, volumes and routes of administration, if included, are listed as defaults. They may vary between institutions and can be substituted to reflect individual institutional policy.

Antiemetics if included in the treatment schedule are based upon recommendations from national and international guidelines. These are defaults only and may be substituted to reflect individual institutional policy. Select here for recommended doses of alternative antiemetics.

Cycle 1 and further cycles

Day 1
Dexamethasone 8 mg (PO) with or after food for 3 doses (twelve hours, three hours and one hour prior to docetaxel administration)
DOCEtaxel 75 mg/m2 (IV infusion) in 250 mL to 500 mL sodium chloride 0.9% over 60 minutes
Prednisolone 10 mg (PO) ONCE a day with or after food. Can be given as 5 mg TWICE a day.
Day 2 to 21
Prednisolone 10 mg (PO) ONCE a day with or after food. Can be given as 5 mg TWICE a day.

* For elderly or Asian patients, consider reducing initial docetaxel dose to 60 mg/m2 or using ID 2028 Prostate metastatic DOCEtaxel two weekly and prednisolone, as per reference committee consensus.

** Prednisolone can be given as 5 mg TWICE a day. It is given continuously during all cycles of treatment. This is often tapered off slowly over a period of 1 month after completion of chemotherapy at the discretion of the medical officer. Note that in castration-sensitive patients, prednisolone was not required. Clinicians may wish to consider minimising use of ongoing prednisolone in castration-resistant patients.

Frequency:
21 days 
Cycles:
Continuous until disease progression or unacceptable toxicity; up to 10 cycles

Cycle 1 and further cycles

Drug Dose Route Day
DOCEtaxel 75 mg/m2 * IV infusion 1
Prednisolone 10 mg ONCE a day ** PO 1 to 21

* For elderly or Asian patients, consider reducing initial docetaxel dose to 60 mg/m2 or using ID 2028 Prostate metastatic DOCEtaxel two weekly and prednisolone, as per reference committee consensus.

** Prednisolone can be given as 5 mg TWICE a day. It is given continuously during all cycles of treatment. This is often tapered off slowly over a period of 1 month after completion of chemotherapy at the discretion of the medical officer. Note that in castration-sensitive patients, prednisolone was not required. Clinicians may wish to consider minimising use of ongoing prednisolone in castration-resistant patients.

Frequency:
21 days 
Cycles:
Continuous until disease progression or unacceptable toxicity; up to 10 cycles
Notes:

Patients had their luteinising hormone-releasing hormone (LHRH) agonist therapy continued.

The study from the key evidencer was performed in fit patients with good performance status and the data is only relevant for such patients. Patients who have had pelvic radiation therapy, pre treatment with radio-isotopes may be more suited to consider dose reductions or a weekly regimen.

Drug status:

Docetaxel is on the PBS general schedule

Cost:
~ $80 per cycle "How this cost is calculated"

The cost displayed on the protocol is intended as rudimentary guide only for the Australian context.

The cost includes anti-cancer drugs only (not antiemetics, supportive medications or consumables), unless otherwise indicated.

Drug unit costs are taken directly from the Pharmaceutical Benefits Scheme (PBS) website (www.pbs.gov.au), MIMS Online and other sources. These costs are reviewed and updated on eviQ at 6 monthly intervals.

Where there are differing unit costs based on vial sizes and tablet strengths, the mean unit cost is used. The cost of oral continuous therapy is based on a 28 day month.

The protocol cost is derived from drug dose calculations based upon a default body surface area (BSA) of 1.8 m2; weight of 75 kg; and creatinine clearance of 75 mL/min.

One off loading doses and ongoing maintenance doses are not included in protocol cost calculations.

The cost displayed is the actual drug cost and does not necessarily reflect the cost incurred by the patient as many anti-cancer drugs are reimbursed on the PBS.

The supportive therapies (e.g. antiemetics, premedications, etc.), infusion times, diluents, volumes and routes of administration, if included, are listed as defaults. They may vary between institutions and can be substituted to reflect individual institutional policy.

Antiemetics if included in the treatment schedule are based upon recommendations from national and international guidelines. These are defaults only and may be substituted to reflect individual institutional policy. Select here for recommended doses of alternative antiemetics.

Cycle 1 and further cycles

Day 1
Dexamethasone 8 mg (PO) with or after food for 3 doses (twelve hours, three hours and one hour prior to docetaxel administration)
DOCEtaxel 75 mg/m2 (IV infusion) in 250 mL to 500 mL sodium chloride 0.9% over 60 minutes
Prednisolone 10 mg (PO) ONCE a day with or after food. Can be given as 5 mg TWICE a day.
Day 2 to 21
Prednisolone 10 mg (PO) ONCE a day with or after food. Can be given as 5 mg TWICE a day.

* For elderly or Asian patients, consider reducing initial docetaxel dose to 60 mg/m2 or using ID 2028 Prostate metastatic DOCEtaxel two weekly and prednisolone, as per reference committee consensus.

** Prednisolone can be given as 5 mg TWICE a day. It is given continuously during all cycles of treatment. This is often tapered off slowly over a period of 1 month after completion of chemotherapy at the discretion of the medical officer. Note that in castration-sensitive patients, prednisolone was not required. Clinicians may wish to consider minimising use of ongoing prednisolone in castration-resistant patients.

Frequency:
21 days 
Cycles:
Continuous until disease progression or unacceptable toxicity; up to 10 cycles
  • Androgen independent (castration resistant) metastatic prostate cancer
Venous access required

IV cannula (IVC) or central venous access device (CVAD) is required to administer this treatment.

Read more about central venous access device line selection
Hypersensitivity/infusion related reaction

High risk with docetaxel

Read more about Hypersensitivity reaction
Premedication

The product information states that premedication is required for this treatment.
Please refer to the treatment schedule for the suggested premedication regimen.
This may be substituted to reflect institutional policy.

Read more about premedication for prophylaxis of taxane hypersensitivity reactions
Emetogenicity LOW

Suggested default antiemetics have been added to the treatment schedule, and may be substituted to reflect institutional policy.

Ensure that patients also have sufficient antiemetics for breakthrough emesis:

Metoclopramide 10 mg three times a day when necessary (maximum of 30 mg/24 hours, up to 5 days) OR

Prochlorperazine 10 mg PO every 6 hours when necessary.

Read more about preventing anti-cancer therapy induced nausea and vomiting
Corticosteroids

Diabetic patients should monitor their blood glucose levels closely. To minimise gastric irritation, advise patient to take immediately after food. Consider the use of a H2 antagonist or proton pump inhibitor if appropriate.

Read more about acute short term effects from corticosteroids
Peripheral neuropathy

Assess prior to each treatment. If a patient experiences grade 3 or greater, cessation of drug is recommended; review by medical officer before commencing treatment.

Read more about peripheral neuropathy

Link to chemotherapy-induced peripheral neuropathy screening tool
Bone modifying agents

The use of a bone modifying agent (BMA) should be considered as it may prevent skeletal related events and improve bone mineral density. Bone modifying agents include bisphosphonates (e.g. zoledronic acid and pamidronate) and the monoclonal antibody denosumab.
Blood tests

FBC, EUC, eGFR and LFTs at baseline and prior to each cycle.
Hepatitis B screening and prophylaxis

Routine screening for HBsAg and anti-HBc is NOT usually recommended for patients receiving this treatment.

Read more about hepatitis B screening and prophylaxis in cancer patients requiring cytotoxic and/or immunosuppressive therapy
Vaccinations

Live vaccines are contraindicated in cancer patients receiving immunosuppressive therapy and/or who have poorly controlled malignant disease.

Refer to the recommended schedule of vaccination for immunocompromised patients, as outlined in the Australian Immunisation Handbook.

Read more about COVID-19 vaccines and cancer.
Fertility and fathering a child

Cancer treatment can have harmful effects on fertility and this should be discussed with all patients of reproductive potential prior to commencing treatment. It is important that all patients of reproductive potential use effective contraception whilst on therapy and after treatment finishes. Effective contraception methods and contraception timeframe should be discussed with all patients of reproductive potential.

Read more about the effect of cancer treatment on fertility
Evidence for dose modifications is limited, and the recommendations made on eviQ are intended as a guide only. They are generally conservative with an emphasis on safety. Any dose modification should be based on clinical judgement, and the individual patient’s situation including but not limited to treatment intent (curative vs palliative), the anti-cancer regimen (single versus combination therapy versus chemotherapy versus immunotherapy), biology of the cancer (site, size, mutations, metastases), other treatment related side effects, additional co-morbidities, performance status and patient preferences.Suggested dose modifications are based on clinical trial findings, product information, published guidelines and reference committee consensus . The dose reduction applies to each individual dose and not to the total number of days or duration of treatment cycle unless stated otherwise. Non-haematological gradings are based on Common Terminology Criteria for Adverse Events (CTCAE) unless otherwise specified. Renal and hepatic dose modifications have been standardised where possible. For more information see dosing considerations & disclaimer.

Note: All dose reductions are calculated as a percentage of the starting dose.

Haematological toxicity
ANC x 109/L (pre-treatment blood test)
1.0 to less than 1.5 Refer to local institutional guidelines; it is the view of the expert clinicians that treatment should continue if patient is clinically well
0.5 to less than 1.0 Delay treatment until recovery
less than 0.5 Delay treatment until recovery and consider reducing docetaxel by 25% for subsequent cycles
Febrile neutropenia Delay treatment until recovery and consider reducing docetaxel by 25% for subsequent cycles
Platelets x 109/L (pre-treatment blood test)
75 to less than 100 The general recommendation is to delay, however if the patient is clinically well it may be appropriate to continue treatment; refer to treating team and/or local institutional guidelines
50 to less than 75 Delay treatment until recovery
less than 50 Delay treatment until recovery and consider reducing docetaxel by 25% for subsequent cycles
Kidney dosing recommendations 
  • Suggested dose modifications are based on the International Consensus Guideline on Anticancer Drug Dosing in Kidney Dysfunction (ADDIKD).
  • Where one or more drugs in a protocol is recommended to be avoided, consider using a clinically appropriate alternative treatment protocol instead.
  • Before dose adjusting or omitting a drug, consider treatment intent.
  • In kidney replacement therapy consult a multidisciplinary team consisting of oncology/haematology with nephrology and/or clinical pharmacology for the management of dosing. 
  • For complete information on individual drug recommendations please review the individual drug monograph in the ADDIKD guideline.
eGFR
(mL/min/1.73m2)		 Docetaxel Prednisolone*
≥ 60

Full dose

No dose reduction required in kidney dysfunction.

 

 

 

 

 

 
45 - 59

Full dose
30 - 44

Full dose
15 - 29

Full dose
< 15
(without kidney replacement therapy)

Full dose
* This drug was not included in the ADDIKD guideline.
Hepatic impairment
Hepatic dysfunction
Minimal Reduce docetaxel by 25%
Mild Reduce docetaxel by 50%
Moderate/Severe Omit docetaxel
Peripheral neuropathy
Grade 2 which is present at the start of the next cycle Consider ceasing docetaxel
Grade 3 or Grade 4 Omit docetaxel
Mucositis and stomatitis
Grade 2 Delay treatment until toxicity has resolved to Grade 1 or less and reduce the dose for subsequent cycles as follows:
1st occurrence: No dose reduction
2nd occurrence: Reduce docetaxel by 25%
3rd occurrence: Reduce docetaxel by 50%
4th occurrence: Omit docetaxel
Grade 3 or Grade 4 Delay treatment until toxicity has resolved to Grade 1 or less and reduce the dose for subsequent cycles as follows:
1st occurrence: Reduce docetaxel by 50%
2nd occurrence: Omit docetaxel

Drug interactions in eviQ protocols are under review and being updated to align with current literature. Further site-wide updates and changes will occur in due course. References & Disclaimer

The drug interactions shown below are not an exhaustive list. For a more comprehensive list and for detailed information on specific drug interactions and clinical management, please refer to the specific drug product information and the following key resources: 

Docetaxel
  Interaction Clinical management
CYP3A4 and P-gp inhibitors (e.g. amiodarone, aprepitant, azole-antifungals, ritonavir, lapatinib, nilotinib, sorafenib, macrolides, ciclosporin, grapefruit juice etc.) Increased toxicity of docetaxel possible due to reduced clearance Avoid combination or monitor for docetaxel toxicity
CYP3A4 inducers (e.g. carbamazepine, phenytoin, phenobarbitone, rifampicin, St John’s wort etc.) Reduced efficacy of docetaxel possible due to increased clearance Avoid combination or monitor for decreased clinical response to docetaxel
Prednisolone
  Interaction Clinical management
Antidiabetic agents (e.g. insulin, glibenclamide, glicazide, metformin, pioglitazone, etc) The efficacy of antidiabetic agents may be decreased Use with caution and monitor blood glucose
Azole antifungals (e.g. fluconazole, itraconazole, ketoconazole, posaconazole) Increased toxicity of prednisolone possible due to reduced clearance Avoid combination or monitor for prednisolone toxicity
Oestrogens (e.g. oral contraceptives) Increased toxicity of prednisolone possible due to reduced clearance Avoid combination or monitor for prednisolone toxicity. Dose reduction of prednisolone may be required
Ritonavir Increased toxicity of prednisolone possible due to reduced clearance Avoid combination or monitor for prednisolone toxicity
General
  Interaction Clinical management
Warfarin Anti-cancer drugs may alter the anticoagulant effect of warfarin. Monitor INR regularly and adjust warfarin dosage as appropriate; consider alternative anticoagulant.
Direct oral anticoagulants (DOACs) e.g. apixaban, rivaroxaban, dabigatran

Interaction with both CYP3A4 and P-gp inhibitors /inducers.

DOAC and anti-cancer drug levels may both be altered, possibly leading to loss of efficacy or toxicity (i.e. increased bleeding).

Apixaban: avoid concurrent use with strong CYP3A4 and P‑gp inhibitors. If treating VTE, avoid use with strong CYP3A4 and P‑gp inducers. 

Rivaroxaban: avoid concurrent use with strong CYP3A4 and P‑gp  inhibitors.

Dabigatran: avoid combination with strong P‑gp inducers and inhibitors.

If concurrent use is unavoidable, monitor closely for efficacy/toxicity of both drugs.
Digoxin Anti-cancer drugs can damage the lining of the intestine; affecting the absorption of digoxin. Monitor digoxin serum levels; adjust digoxin dosage as appropriate.
Antiepileptics Both altered antiepileptic and anti-cancer drug levels may occur, possibly leading to loss of efficacy or toxicity. Where concurrent use of an enzyme-inducing antiepileptic cannot be avoided, monitor antiepileptic serum levels for toxicity, as well as seizure frequency for efficacy; adjust dosage as appropriate.
Also monitor closely for efficacy of the anti-cancer therapy.
Antiplatelet agents and NSAIDs Increased risk of bleeding due to treatment related thrombocytopenia. Avoid or minimise combination.
If combination deemed essential, (e.g. low dose aspirin for ischaemic heart disease) monitor for signs of bleeding.
Serotonergic drugs, including selective serotonin reuptake inhibitors (SSRIs e.g. paroxetine) and serotonin noradrenaline reuptake inhibitors (SNRIs e.g. venlafaxine) Increased risk of serotonin syndrome with concurrent use of 5-HT3 receptor antagonists (e.g. palonosetron, ondansetron, granisetron, tropisetron, dolasetron, etc.) Avoid combination.
If combination is clinically warranted, monitor for signs and symptoms of serotonin syndrome (e.g. confusion, agitation, tachycardia, hyperreflexia).
For more information link to TGA Medicines Safety Update
Vaccines Diminished response to vaccines and increased risk of infection with live vaccines. Live vaccines (e.g. BCG, MMR, zoster and varicella) are contraindicated in patients on immunosuppressive therapy. Use with caution in patients on non-immunosuppressive therapy.
For more information; refer to the recommended schedule of vaccination for cancer patients, as outlined in the Australian Immunisation Handbook

eviQ provides safe and effective instructions on how to administer cancer treatments. However, eviQ does not provide every treatment delivery option, and is unable to provide a comprehensive list of cancer treatment agents and their required IV line giving set/filter. There may be alternative methods of treatment administration, and alternative supportive treatments that are also appropriate. Please refer to the individual product information monographs via the TGA website for further information.

Day 1

Approximate treatment time: 90 minutes

General patient assessment prior to each day of treatment.

Peripheral neuropathy assessment tool.

Any toxicity grade 3 or greater may require dose reduction, delay or omission of treatment and review by medical officer before recommencing treatment.

Prime IV line(s).

Insert IV cannula or access TIVAD or CVAD.

Pre treatment medication

Verify premedication taken or administer as prescribed.

Prednisolone

  • administer orally ONCE daily
  • to be taken in the morning with or immediately after food

Note: missed doses should not be replaced; if a tablet is forgotten or vomited, normal dosing should be resumed at the next scheduled dose.

Docetaxel

Prior to administration:
  • assess patient for fluid retention or weight gain prior to each cycle
    • notify medical officer of any signs of fluid retention or unexplained weight gain.

The medicines information reference publications stipulate the use of non-PVC containing bags and administration sets. However, this is not consistently recommended in the product information, therefore the decision should be at the discretion of the administering unit.

Administer docetaxel (irritant with vesicant properties):
  • via IV infusion over 60 minutes
  • observe for hypersensitivity reactions
  • flush with ~ 100 mL of sodium chloride 0.9%.

Stop infusion at first sign of reaction:

  • if symptoms are mild and resolve when infusion is stopped, consider recommencing infusion after review by medical officer at a slower rate.
  • for severe reactions seek medical assistance immediately and do not restart infusion.

Remove IV cannula and/or deaccess TIVAD or CVAD. 

Continue safe handling precautions until 7 days after completion of drug(s)

Discharge information

Premedication
  • Premedication for next cycle of chemotherapy.
Prednisolone tablets
  • Prednisolone tablets with written instructions on how to take them.
Antiemetics
  • Antiemetics as prescribed.
Patient information
  • Ensure patient receives patient information sheet.

The side effects listed below are not a complete list of all possible side effects for this treatment. Side effects are categorised into the approximate onset of presentation and should only be used as a guide.

Immediate (onset hours to days)
Hypersensitivity reaction

Anaphylaxis and infusion related reactions can occur with taxanes.

Read more about premedication for prophylaxis of taxane hypersensitivity reactions
Nausea and vomiting

Read more about prevention of treatment induced nausea and vomiting
Taste and smell alteration

Read more about taste and smell changes

Early (onset days to weeks)
Neutropenia

Abnormally low levels of neutrophils in the blood. This increases the risk of infection. Any fever or suspicion of infection should be investigated immediately and managed aggressively. 

Read more about immediate management of neutropenic fever
Thrombocytopenia

A reduction in the normal levels of functional platelets, increasing the risk of abnormal bleeding.  

Read more about thrombocytopenia
Oral mucositis

Erythematous and ulcerative lesions of the gastrointestinal tract (GIT). It commonly develops following chemotherapy, radiation therapy to the head, neck or oesophagus, and high dose chemotherapy followed by a blood and marrow transplant (BMT).

Read more about oral mucositis
Diarrhoea

Read more about treatment induced diarrhoea
Skin rash

Anti-cancer drugs can cause a number of changes in the skin with maculo-papular rash the most common type of drug-induced skin reaction. 

Read more about skin rash
Peripheral neuropathy

Typically symmetrical sensory neuropathy, affecting the fingers and toes, sometimes progressing to the hands and feet.  It is associated with several classes of anti-cancer drugs. These include taxanes, platinum-based compounds, vinca alkaloids and some drugs used to treat multiple myeloma.

Read more about peripheral neuropathy
Palmar-plantar erythrodysaesthesia (PPE) - hand-foot syndrome (HFS)

Bilateral erythema, tenderness, pain, swelling, tingling, numbness, pruritus, dry rash, or moist desquamation and ulceration of the palms and soles. It is also known as hand-foot syndrome (HFS). Symptoms appear to be dose dependent and palms are affected more than soles.

Read more about hand-foot syndrome associated with chemotherapy
Arthralgia and myalgia

Generalised joint pain or and/or stiffness and muscle aches, often worse upon waking or after long periods of inactivity. Can improve with movement. May be mild or severe, intermittent or constant and accompanied by inflammation. 

Read more about arthralgia and myalgia
Ocular changes

Symptoms may include eye pain, blurred vision, blepharitis, uveitis, optic neuritis, tear duct stenosis, conjunctivitis, hyperlacrimation, watery or dry eyes and photophobia. 
Fatigue

Read more about fatigue
Fluid retention syndrome

Fluid retention, including peripheral oedema and weight gain, may occur with docetaxel treatment. The main risk factor for development is cumulative docetaxel dose. Pre-medication with dexamethasone may be used. Fluid retention will slowly resolve after cessation of treatment.

Read more about fluid retention syndrome associated with docetaxel
Side effects of corticosteroids

Insomnia, oedema, increased risk of infection e.g. oral thrush, gastric irritation, worsening of peptic ulcer disease, increased blood sugar levels, loss of diabetic control, mood and behavioural changes - including anxiety, euphoria, depression, mood swings, increased appetite and weight gain, osteoporosis and fractures (long term use), bruising and skin fragility are associated with corticosteroid use.

Late (onset weeks to months)
Anaemia

Abnormally low levels of red blood cells (RBCs) or haemoglobin in the blood. 

Read more about anaemia
Alopecia - partial

Hair thinning and/or patchy hair loss. Patients can also experience mild to moderate discomfort of the hair follicles, and rarely pain as the hair is falling out.

Read more about alopecia and scalp cooling
Nail changes

Hyperpigmentation, paronychia, onycholysis, splinter haemorrhage, pyogenic granuloma formation, subungal haematoma and subungal hyperkeratosis are some of the nail changes associated with anti-cancer drugs.   

Read more about nail toxicities

The key evidence for this regimen comes from the Tannock study, a large (1006 patients) phase lll study comparing 3 treatment arms. Docetaxel 75 mg/m2 3 weekly, docetaxel 30 mg/m2 weekly and mitozantrone 3 weekly. All received prednisone 5 mg twice daily.

This trial demonstrated a survival benefit for the 3 weekly docetaxel. It also showed a quality of life benefit, symptomatic, pain response and overall and PSA response benefit of 3 weekly docetaxel over the two treatment arms. The median survival was 18.9 months in 3 weekly docetaxel compared with 17.4 and 16.5 months in the weekly and mitozantrone prednisone arms respectively.r

A phase III trial comparing docetaxel and estramustine confirmed a similar survival advantage of 3 weekly docetaxel over mitozantrone/prednisone.r

These studies have resulted in 3 weekly docetaxel becoming the new standard of care for this group of patients.

Efficacy

Men receiving 3 weekly docetaxel had a hazard ratio for death of 0.76 (95% CI, 0.62 to 0.94 p=0.0009) and those given weekly docetaxel had a hazard ratio for death of 0.91(95% CI, 0.75 to 1.11; p=0.36) compared with the previous standard of care, Mitozantrone.

The median survival in the mitozantrone group was 16.5 months, in the docetaxel 3 weekly group 18.9 months and docetaxel weekly group 17.4 months.

Overall Survival:r

© N Engl JMed 2004

Toxicity

The incidence of grade 3-4 neutropenia was relatively low, and febrile neutropenia was rare. Two patients died from sepsis during treatment, one in the docetaxel arm and one in the mitozantrone arm. There was a higher incidence of cardiac events among those who received mitozantrone. Most other adverse events were more frequent among patients receiving docetaxel.r

© N Engl J Med 2004

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Bibliography

Berry, W., S. Dakhil, M. Modiano, et al. 2002. "Phase III study of mitoxantrone plus low dose prednisone versus low dose prednisone alone in patients with asymptomatic hormone refractory prostate cancer." J Urol 168(6):2439-2443.

PURPOSE: We compared median time to treatment failure of men with asymptomatic, hormone refractory, progressive prostate cancer treated with mitoxantrone plus prednisone versus prednisone alone. MATERIALS AND METHODS: In a multicenter phase III trial 120 men with asymptomatic, progressive, hormone refractory prostate cancer were randomly assigned to treatment with mitoxantrone and prednisone or prednisone alone. Patients received 12 mg./m. mitoxantrone intravenously once every 3 weeks for 6 cycles and 5 mg. prednisone twice daily with or without mitoxantrone. Time to treatment failure was assessed as an aggregate end point comprised of time to disease progression, time to toxicity or death, or time to initiation of alternate therapy. RESULTS: Median followup was 21.8 months. Median time to treatment failure and median time to progression were the same: time to treatment failure and time to progression in the mitoxantrone and prednisone group was 8.1 months compared to 4.1 months in the prednisone alone group (p = 0.017 versus p = 0.018). More patients (27 or 48%) treated with mitoxantrone and prednisone achieved a 50% or greater reduction in prostate specific antigen levels than those who received only prednisone (15 or 24%, p = 0.007). There was no significant difference in median survival between the 2 groups, which was 23 and 19 months, respectively. Death was mainly attributable to disease progression. CONCLUSIONS: Patients with hormone refractory prostate cancer who are asymptomatic but had progressive disease had a significantly higher response rate when treated with mitoxantrone and prednisone as demonstrated by the 50% or greater decrease in prostate specific antigen compared to treatment with prednisone alone. Time to treatment failure was significantly prolonged in the chemotherapy treated group but survival rates were not different.

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Version 7

Date Summary of changes
27/07/2023

Protocol updated with ADDIKD guideline recommendations. New kidney dosing recommendation table added to dose modification section.

PDF of previous protocol.

Version number changed to V.7.

Version 6

Date Summary of changes
04/05/2007 Patient Information updated.
23/11/2007 PBS listing updated.
27/06/2008 Clarification of length of prednisolone treatment added.
06/01/2010 Review, new dose modifications and transferred to eviQ
02/07/2010 Haematological dose modifications updated ( 20% changed to 25% dose reduction).
14/01/2011 Prednisolone added to the table in patient information sheet.
21/02/2011 New format to allow for export of protocol information.
Protocol version number changed to V.2.
Antiemetics and premedications added to the treatment schedule.
Additional Clinical Information, Key Prescribing table and Key Administration table combined into new section titled Clinical Considerations.
Drug specific information placed behind the drug name link.
13/12/2011 PHC view added.
30/11/2012 Protocol reviewed at Medical Oncology Reference Committee meeting.
Prednisolone - added option to give 10 mg once daily.
Next review in 2 years.
27/02/2014 PHC - dexamethasone premedication corrected.
09/05/2014 Reviewed electronically by Medical Oncology Reference Committee; no changes. PHC view removed. Review 2 years.
31/03/2017 Protocol discussed and decided to have a 5 year review period. Next due for review in 2019.
31/05/2017

Transferred to new eviQ website. Protocol version changed to V.4.

Link to the independent evaluation of the evidence completed in 2006/7 removed from the evidence section as no longer relevant.

Hepatitis screening changed to not recommended.

Prednisolone dose changed to 10 mg daily with a note that 5 mg BD may be given due to current clinical practice.
10/05/2018 Haematological dose modifications updated as per consensus of the expert clinician group. Version number changed to V.5.
02/04/2019 Protocol reviewed at Medical Oncology Reference Committee meeting on 15/03/2019. Treatment schedule note updated to include option for docetaxel dose 60 mg/m2 for elderly or Asian patients, and option to omit prednisolone. Version number changed to V.6. Next review in 5 years.

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https://www.eviq.org.au/p/249

04 Dec 2023