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Acute myeloid leukaemia consolidation 5-2 (cytarabine and DAUNOrubicin) SUPERSEDED

This protocol has been superseded because it is not commonly used in clinical practice.

This protocol was published over 10 years ago and has been assessed by the reference committee as suitable to be reviewed as required. The review due date has been removed. If something in this protocol requires reference committee consideration, please click on the feedback button at the bottom of the page.

Read more about the as required review process in this factsheet.

Patients with leukaemia should be considered for inclusion into clinical trials. Link to ALLG website opens in a new tab or window and ANZCTR website opens in a new tab or window.

This protocol is based on limited evidence; refer to the evidence section of this protocol for more information.

Link to Australian National AML Clinical Guideline opens in a new tab or window

On this page
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Drug Dose Route Day
DAUNOrubicin 50 mg/m2 IV 1 and 2
Cytarabine (Ara-C) 100 mg/m2 CIV 1 to 5
Cycles:
1 or 2. First cycle commenced on confirmation of induction remission. A second cycle may be administered after bone marrow recovery.
Drug status:

Cytarabine: PBS general schedule opens in a new tab or window
Daunorubicin: TGA registered but not PBS listed for this indication

Cost:
~ $120 per cycle, excluding daunorubicin. "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). These costs are reviewed and updated on eviQ at 6 monthly intervals. Anti-cancer drugs that are not included on the PBS do not have a cost included in eviQ protocols.

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.

Where oral drugs are available on the PBS for both 30- and 60-day prescriptions, the unit cost for the 30-day supply is used.

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, growth factor support 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.

Day 1 and 2
DAUNOrubicin 50 mg/m2 (IV) over 5 to 15 minutes
Cytarabine (Ara-C) 100 mg/m2 (CIV) in sodium chloride 0.9% over 24 hours as a continuous infusion
Day 3 to 5
Cytarabine (Ara-C) 100 mg/m2 (CIV) in sodium chloride 0.9% over 24 hours as a continuous infusion
Cycles:
1 or 2. First cycle commenced on confirmation of induction remission. A second cycle may be administered after bone marrow recovery.
Drug Dose Route Day
DAUNOrubicin 50 mg/m2 IV 1 and 2
Cytarabine (Ara-C) 100 mg/m2 CIV 1 to 5
Cycles:
1 or 2. First cycle commenced on confirmation of induction remission. A second cycle may be administered after bone marrow recovery.
Drug status:

Cytarabine: PBS general schedule opens in a new tab or window
Daunorubicin: TGA registered but not PBS listed for this indication

Cost:
~ $120 per cycle, excluding daunorubicin. "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). These costs are reviewed and updated on eviQ at 6 monthly intervals. Anti-cancer drugs that are not included on the PBS do not have a cost included in eviQ protocols.

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.

Where oral drugs are available on the PBS for both 30- and 60-day prescriptions, the unit cost for the 30-day supply is used.

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, growth factor support 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.

Day 1 and 2
DAUNOrubicin 50 mg/m2 (IV) over 5 to 15 minutes
Cytarabine (Ara-C) 100 mg/m2 (CIV) in sodium chloride 0.9% over 24 hours as a continuous infusion
Day 3 to 5
Cytarabine (Ara-C) 100 mg/m2 (CIV) in sodium chloride 0.9% over 24 hours as a continuous infusion
Cycles:
1 or 2. First cycle commenced on confirmation of induction remission. A second cycle may be administered after bone marrow recovery.
  • Post remission acute myeloid leukaemia in patients not suitable for consolidation with high dose cytarabine
Venous access

Central venous access device (CVAD) is required to administer this treatment.

Read more about central venous access device line selection
Antiemetics for multi-day protocols

Patients being treated with multi-day anticancer protocols should receive antiemetics tailored to the emetogenic risk of the drugs administered each day during treatment and for two days after completion of the anticancer protocol.

No standard antiemetic regimen exists for multi-day anticancer protocols. A combination of an NK1 receptor antagonist, 5HT3, and a steroid is available on the PBS for the prevention of nausea and vomiting associated with all moderate to highly emetogenic anti-cancer therapies. 

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
Cumulative lifetime dose of anthracyclines

Cumulative doses should take into account all previous anthracyclines received during a patient’s lifetime (i.e. daunorubicin, doxorubicin, epirubicin, idarubicin and mitoxantrone). 

Criteria for reducing the total anthracycline cumulative lifetime dose include:

  • patient is elderly
  • prior mediastinal radiation
  • hypertensive cardiomegaly
  • concurrent therapy with high dose cyclophosphamide and some other cytotoxic drugs (e.g. bleomycin, dacarbazine, dactinomycin, etoposide, melphalan, mitomycin and vincristine).

Baseline clinical assessments include echocardiogram (ECHO) or gated heart pool scan (GHPS) and electrocardiogram (ECG) evaluation.

Patients with normal baseline cardiac function (left ventricular ejection fraction (LVEF) > 50%) and low risk patients require LVEF monitoring when greater than 70% of the anthracycline threshold is reached or if the patient displays symptoms of cardiac impairment. Post-treatment cardiac monitoring is recommended for patients who have received high levels of total cumulative doses of anthracyclines at the clinician's discretion.

Read more about cardiac toxicity associated with anthracyclines
Cytarabine syndrome

Treatment with cytarabine may cause a "cytarabine syndrome" characterised by flu-like symptoms, skin rash and occasionally chest pain.
Tumour lysis risk

Assess patient for risk of developing tumour lysis syndrome.

Read more about prevention and management of tumour lysis syndrome.
Pneumocystis jirovecii pneumonia (PJP) prophylaxis

­

Read more about prophylaxis of pneumocystis jiroveci (carinii) in cancer patients
Antiviral prophylaxis

­

Read more about antiviral prophylaxis drugs and doses
Antifungal prophylaxis ­

Read more about antifungal prophylaxis drugs and doses.
Growth factor support

G-CSF (short or long-acting) is available on the PBS for chemotherapy induced neutropenia depending on clinical indication and/or febrile neutropenia risk.  

Access the PBS website opens in a new tab or window
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 recommended prior to initiation of treatment. Prophylaxis should be determined according to individual institutional policy.

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. Possible suboptimal response to inactivated vaccines.

For more information about vaccinations in people with cancer refer to the Australian Immunisation Handbook opens in a new tab or window.
Fertility, pregnancy and lactation

Cancer treatment can have harmful effects on fertility and this should be discussed with all patients of reproductive potential prior to commencing treatment. There is a risk of fetal harm in pregnant women. A pregnancy test should be considered prior to initiating treatment in females of reproductive potential if sexually active. It is important that all patients of reproductive potential use effective contraception whilst on therapy and after treatment finishes. Effective contraception methods and adequate contraception timeframe should be discussed with all patients of reproductive potential. Possibility of infant risk should be discussed with breastfeeding patients.

Read more about the impact of cancer treatment on fertility opens in a new tab or window
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) opens in a new tab or window 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
Dose reductions for haematological toxicity not usually recommended. Discuss with Haematologist. Consider adding G-CSF opens in a new tab or window from Day 6.
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)		 Cytarabine* Daunorubicin
≥ 60

Full dose

Full dose
45 - 59

Full dose

Full dose

Potential for increased risk of adverse events
30 - 44

Full dose

Full dose

Potential for increased risk of adverse events
15 - 29

Full dose

Full dose

OR

Reduce by 25% in patients with

- non-curative treatment intent, and

- poor performance status

Potential for increased risk of adverse events
< 15
(without kidney replacement therapy)

Full dose

Consult a multidisciplinary team consisting of oncology/haematology with nephrology and/or clinical pharmacology for the management of dosing.
* Cytarabine dose modifications based on low dose cytarabine (< 1000 mg/m2) recommendations 
Hepatic impairment
Hepatic dysfunction  
Mild Reduce daunorubicin by 25%
Moderate Reduce daunorubicin by 50%
Severe Omit daunorubicin. Consider alternative regimen.

Elevations in liver function tests occur with both standard and high dose cytarabine. Significant liver function abnormalities may require discontinuation or a dose reduction

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:  

For more information see References & Disclaimer.

Cytarabine
  Interaction Clinical management
Cytidine deaminase (CDA) inhibitors (e.g. cedazuridine) Potential increased effect/toxicity of cytarabine due to reduced clearance Avoid combination or monitor for increased cytarabine effect/toxicity
Daunorubicin
  Interaction Clinical management
Nephrotoxic drugs (e.g. aminoglycosides, amphotericin, contrast dye, frusemide, NSAIDs) Additive nephrotoxicity Avoid combination or monitor kidney function closely
Cardiotoxic drugs (eg. calcium channel blockers, propranolol) Increased risk of daunorubicin-induced cardiotoxicity Avoid combination or monitor closely for cardiotoxicity
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 opens in a new tab or window and P‑gp opens in a new tab or window inhibitors. If treating VTE, avoid use with strong CYP3A4 opens in a new tab or window and P‑gp opens in a new tab or window inducers. 

Rivaroxaban: avoid concurrent use with strong CYP3A4 opens in a new tab or window and P‑gp opens in a new tab or window  inhibitors.

Dabigatran: avoid combination with strong P‑gp opens in a new tab or window 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 opens in a new tab or window

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 or address chemical compatibilities related to IV drug preparation and administration. 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 opens in a new tab or window and Australian Injectable Drugs Handbook opens in a new tab or window websites for further information.

eviQ is currently updating the way information is presented in the administration section, if you notice any discrepancies please let us know, via feedback@eviq.org.au.

Days 1 and 2

Pre treatment assessment

Any toxicity grade 2 or greater may require dose reduction, delay or omission of treatment and review by medical officer before commencing treatment.

Anti-cancer drug patient assessment tool prior to each day of treatment.

Weigh patient.

Strict fluid balance.

Pre treatment medication

Verify antiemetics taken or administer as prescribed.

Prior to administration

Prime IV line(s).

Access CVAD.

Daunorubicin

Extravasation of a vesicant is a medical emergency. Monitor for signs of extravasation throughout administration.

Administer daunorubicin (vesicant):
  • over 5 to 15 minutes
    • via a minibag OR
    • by IV bolus via a side port of a freely flowing IV infusion
  • flush with ~150 mL of sodium chloride 0.9%.
Potential adverse events:
  • potential for flare reaction during administration of daunorubicin (facial flushing and red streaking along the vein), stop infusion and exclude extravasation before continuing at a slower rate of infusion
  • although rare, cardiac arrhythmias may occur during or immediately after daunorubicin administration, if sudden onset of dyspnoea, palpitations or irregular pulse occurs, stop administration immediately and obtain urgent medical officer review.

Cytarabine 

Administer cytarabine:
  • via continuous IV infusion over 5 days
  • hang a new bag every 24 hours
  • do not interrupt the infusion of cytarabine.
Potential adverse events:
  • cytarabine syndrome:
    • fever, myalgia, bone pain, and/or occasionally rash, chest pain, or conjunctivitis which can occur 6 to 12 hours following drug administration
    • symptoms usually resolve within 24 hours after cytarabine is discontinued
    • corticosteroids may be used for treatment and prophylaxis.

Post administration

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

Days 3 to 5

Pre treatment assessment

Any toxicity grade 2 or greater may require dose reduction, delay or omission of treatment and review by medical officer before commencing treatment.

Anti-cancer drug patient assessment tool prior to each day of treatment.

Weigh patient.

Strict fluid balance.

Pre treatment medication

Verify antiemetics taken or administer as prescribed.

Prior to administration

Prime IV line(s).

Cytarabine 

Administer cytarabine:
  • via continuous IV infusion over 5 days
  • hang a new bag every 24 hours
  • do not interrupt the infusion of cytarabine.
Potential adverse events:
  • cytarabine syndrome:
    • fever, myalgia, bone pain, and/or occasionally rash, chest pain, or conjunctivitis which can occur 6 to 12 hours following drug administration
    • symptoms usually resolve within 24 hours after cytarabine is discontinued
    • corticosteroids may be used for treatment and prophylaxis.

Post administration

Deaccess CVAD.

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

Discharge information

Discharge medications

Growth factor support - as/if prescribed, and arrangements for administration.

Antiemetics - as/if prescribed.

Prophylaxis medications - as/if prescribed, i.e. antifungals, antivirals, PJP prophylaxis, tumour lysis prophylaxis.

Patient information

Ensure patient receives protocol 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)
Extravasation, tissue or vein injury

The unintentional instillation or leakage of a drug or substance out of a blood vessel into surrounding tissue. This has the potential to cause damage to affected tissue.

Read more about extravasation management
Flare reaction

Anthracycline flare reaction is caused by a localised allergic reaction. It is characterised by erythematous vein streaking, urticaria and pruritus which may occur during drug administration and is often associated with too rapid an infusion. Extravasation must be ruled out if flare occurs.
Cytarabine (Ara-C) syndrome

Flu-like symptoms including fever, myalgia and malaise can occur 6 to 12 hours after cytarabine administration. Symptoms generally resolve within 24 hours of completing therapy.
Nausea and vomiting

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

Read more about taste and smell changes
Red-orange discolouration of urine

Pink/red/orange discolouration of the urine. This can last for up to 48 hours after some anthracycline drugs.

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
Radiation recall

Erythematous or inflammatory skin reaction resembling severe sunburn at sites previously treated with radiation therapy can occur with certain anti-cancer drugs. Symptoms include vesiculation, desquamation and ulceration of the skin.

Read more about radiation recall
Oral mucositis and stomatitis

Erythematous and ulcerative lesions of the gastrointestinal tract (GIT). It commonly develops following anti-cancer treatment, 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 and stomatitis
Anorexia

Loss of appetite accompanied by decreased food intake.

Read more about anorexia
Fatigue

Read more about fatigue
Diarrhoea

Read more about treatment induced diarrhoea
Photosensitivity

Increased sensitivity to ultraviolet (UV) light resulting in an exaggerated sunburn-like reaction accompanied by stinging sensations and urticaria.

Late (onset weeks to months)
Anaemia

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

Read more about anaemia
Alopecia

Hair loss may occur from all parts of the body. 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
Cognitive changes (chemo fog)

Changes in cognition characterised by memory loss, forgetfulness and feeling vague. This is also referred to as 'chemo brain' or 'chemo fog'.

Read more about cognitive changes (chemo fog) 

Delayed (onset months to years)
Cardiotoxicity

Anthracyclines are the most frequently implicated anti-cancer drugs associated with cardiotoxicity, which typically manifests as a reduction in left ventricular ejection fraction (LVEF), cardiomyopathy, or symptomatic CHF. Anthracycline induced cardiotoxicity has been categorised into acute, early-onset chronic progressive and late-onset chronic progressive and is usually not reversible. The risk of clinical cardiotoxicity increases with a number of risk factors including higher total cumulative doses. 

Read more about cardiac toxicity associated with anthracyclines

eviQ is currently updating the way information is presented in the evidence section to improve usability, consistency and facilitate easier update and maintenance. An updated evidence template is being implemented in a staged approach, first across new protocols, then existing protocols as they are reviewed. Find out more

This protocol has been superseded because it is not commonly used in clinical practice.

Evidence and Efficacy

The addition of a number of cycles of consolidation therapy, which is similar to induction therapy at somewhat reduced doses, or maintenance therapy after 7+3 induction therapy has been shown to improve median complete remission (CR) duration from 7 to 8 months to 8 to 18 months and long term response rates from 10% to 20-30% in non-randomised studies.r It does not appear that addition of maintenance therapy after consolidation therapy improves response rates.r

Two cycles of DAT consolidation therapy (equivalent to 5+2 + thioguanine) followed by maintenance therapy were compared to maintenance therapy alone after achievement of CR with the DAT regimen and there was no improved median CR duration (40 weeks with consolidation versus 34 weeks with maintenance), or overall median survival 72 weeks with consolidation versus 87 weeks with maintenance However, there were different plateaux in probability of remaining in CR at 2 years being 28% in the consolidation arm versus 14% in the maintenance arm which was not significant due to small numbers.r

In a SAKK study, 3 cycles of early consolidation therapy (cytarabine, daunorubicin and vincristine) improved the median survival of patients entering remission from 1 year (based on a previous SAKK study) to 2.5 years but there was no benefit from maintenance therapy after the consolidation therapy with median remission duration of 18 months and median survival of 30 months in both observation and maintenance arms.r

There do not appear to have been randomised trials comparing 5+2 consolidation therapy to other post remission therapies, although 5+2 and 5+2 modified consolidation therapy have been used in a number of trials after 7+3 and 7+3 modified induction therapy using the same anthracycline in consolidation therapy as induction therapy.r

A search of the literature found limited evidence to support the use of cytarabine and daunorubicin 5-2 in the consolidation treatment of AML. The expert reference panel supported publication of the protocol on the basis of the information summarised below. The committee was most strongly influenced by the study by Wiernik el al.r

Source Study & Year Published Supports Use Is the dose and regimen consistent with the protocol? Comments
Randomised trials Wiernik et al. 1992 Yes No Daunorubicin 45 mg/m2 days 1-2 and cytarabine 100 mg/m2 days 1-5 for 2 cycles
  Cassileth et al. 1992 Yes No "
Observational studies N/A N/A N/A -
Case series N/A N/A N/A -
Guidelines Date published/revised Supports Use Is the dose and regimen consistent with the protocol? Comments
NCCN Mar 2014 Yes N/A -
BCCA N/A N/A N/A -
ESMO 2013 N/A N/A -

Toxicity

There was an increased incidence of dysphagia occurring in 15% of patients receiving idarubicin versus 0% in patients receiving daunorubicin but otherwise toxicity was similar in both groups during consolidation therapy in the Wiernik study.r There was an increased incidence of diarrhoea, hyperbilirubinaemia, elevation of transaminases, alkaline phosphatase and urea, infections and more prolonged myelosuppression in idarubicin arm compared to daunorubicin arm in consolidation therapy in the Vogler study.

Haematological toxicity during consolidation therapy:r

© Blood 1992

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Version 7

Date Summary of changes
31/01/2024

Protocol assessed by eviQ Haematology Reference Committee and deemed suitable to be reviewed as required. Flag added, review date removed and version number increased to V.7. Read more about as required review protocol status in this factsheet.
09/02/2024 Drug cost updated to exclude daunorubicin, not available on PBS.

Version 6

Date Summary of changes
26/10/2023

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.6.

Version 5

Date Summary of changes
23/10/2020 Protocol superseded as per the haematology reference committee. Version number changed to V.5.

Version 4

Date Summary of changes
09/09/2008 Addition of information to improve comprehensiveness - including additional drug interactions, clinical considerations (management of tumour lysis syndrome, background information on PCP in patients with malignancy).
10/03/2010 Reviewed and transferred to eviQ.
17/09/2010

Full protocol review at Haematology Reference Committee meeting:
- indication updated to include 'where high dose cytarabine is not appropriate'; age cut off removed
- notes section deleted - no longer relevant
- renal and hepatic dose modification recommendations for cytarabine included
11/04/2012

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.
20/06/2014 Standard review post Haematology Reference Committee meeting:
- Added link to ALLG and ANZCTR with statement 'Patients with AML should be considered for inclusion into clinical trials'. Next review in 2 years
03/02/2016 Standard review , review again in 5 years.

31/05/2017

Transferred to new eviQ website. Version number change to V.4.
10/10/2019 Clinical information updated with PBS expanded indications for G-CSF. 

The information contained in this protocol is based on the highest level of available evidence and consensus of the eviQ reference committee regarding their views of currently accepted approaches to treatment. Any clinician (medical oncologist, haematologist, radiation oncologist, medical physicist, radiation therapist, pharmacist or nurse) seeking to apply or consult this protocol is expected to use independent clinical judgement in the context of individual clinical circumstances to determine any patient's care or treatment. While eviQ endeavours to link to reliable sources that provide accurate information, eviQ and the Cancer Institute NSW do not endorse or accept responsibility for the accuracy, currency, reliability or correctness of the content of linked external information sources. Use is subject to eviQ’s disclaimer available at www.eviQ.org.au

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First approved:
Last reviewed:
Review due:
As required
Superseded:

The currency of this information is guaranteed only up until the date of printing, for any updates please check:

https://www.eviq.org.au/p/344

17 Jun 2025