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Drug Formulary information is intended for use by healthcare professionals. It is not intended to be medical advice. Some of the information, including information about funding for cancer drugs, does not apply to all patients. Cancer treatment plans are unique to each patient. If you are a patient, please speak with your healthcare team to understand how this information applies to you.

A - Regimen Name

 

MXNTPRED Regimen
mitoXANTRONE-Prednisone

 

 

Disease Site
Genitourinary - Prostate

(Metastatic - Stage D)

 

 

Intent
Palliative

 

 

Regimen Category
Evidence-Informed :

Regimen is considered appropriate as part of the standard care of patients; meaningfully improves outcomes (survival, quality of life), tolerability or costs compared to alternatives (recommended by the Disease Site Team and national consensus body e.g. pan-Canadian Oncology Drug Review, pCODR).  Recommendation is based on an appropriately conducted phase III clinical trial relevant to the Canadian context OR (where phase III trials are not feasible) an appropriately sized phase II trial. Regimens where one or more drugs are not approved by Health Canada for any indication will be identified under Rationale and Use.

 

 

Rationale and Uses

Treatment of castration-resistant prostate cancer

 

 

 

Supplementary Public Funding

prednisone
ODB - General Benefit (prednisone)
 

 

 
B - Drug Regimen

 

mitoXANTRONE
 

(Round to nearest 1mg)
12-14 mg /m²IVDay 1
prednisone
 
5 mgPOBID

(Outpatient prescription in multiples of 5mg tablets)

 

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C - Cycle Frequency

 

REPEAT EVERY 21 DAYS

Until disease progression

 

 
D - Premedication and Supportive Measures
 
Antiemetic Regimen:

Low

 
E - Dose Modifications

 

Doses should be modified according to the protocol by which the patient is being treated. The following recommendations are in use at some centres.
Hematologic Toxicities:  See Appendix 6 for general recommendations.

 

Dosage with toxicity

 

Dosage in myelosuppression: 
Modify according to protocol by which patient is being treated; if no guidelines available refer to Appendix 6 "Dosage Modification Hematologic and Non-Hematologic Toxicities". 

 

 

Suggested modifications are:

WBC and Platelet Nadir

(x 109/L)

Time to Recovery

Subsequent Dose

WBC

 

Platelets

 

 

> 1.5

AND

> 50

21 days

No change.  May increase by 2mg/m2 if inadequate myelosuppression

> 21 days

 

Hold until recovery.  Do not increase dose

1 to 1.499

OR

25 to 49

 

Reduce dose by 2mg/m2

< 1

OR

< 25

 

Reduce dose by 4mg/m2

 

 

Hepatic Impairment

Hepatic Impairment
Mitoxantrone Dose
Mild-Moderate
↓ 50%
Bilirubin > 2-3 x ULN
Hold 
Severe
Hold 

 

 

 

 

Renal Impairment

No adjustment required

 
F - Adverse Effects
Refer to mitoXANTrone, prednisone drug monograph(s) for additional details of adverse effects
 
Most frequently occurring adverse effects
  • Nausea and vomiting
  • Cardiotoxicity
  • Myelosuppression
  • Blue-green urine
 
G - Interactions
Refer to mitoXANTrone, prednisone drug monograph(s) for additional details
 
H - Drug Administration and Special Precautions
Refer to mitoXANTrone, prednisone drug monograph(s) for additional details
 
I - Recommended Clinical Monitoring

Recommended Clinical Monitoring

  • Clinical toxicity (including cardiotoxicity) assessment
  • CBC before each cycle
  • Baseline and regular liver & renal function tests
  • Baseline and regular cardiac examination for patients with cardiac risk factors (including prior therapy with Epirubicin, Doxorubicin and other cardiotoxic drugs), and cumulative mitoxantrone doses > 140mg/m2
  • Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version


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J - Administrative Information
 
Approximate Patient Visit
0.5 hour
Pharmacy Workload (average time per visit)
18.198 minutes
Nursing Workload (average time per visit)
43.667 minutes
 
K - References

Berthold DR, Pond GR, Soban F et al. Docetaxel plus prednisone or mitoxantrone plus
prednisone for advanced prostate cancer: updated survival in the TAX 327 study. JCO 2008;
26(2): 242-5.
 
Kantoff PW, Halabi S, Conaway M, et. al. Hydrocortisone with or without mitoxantrone in men with hormone-refractory prostate cancer: results of the cancer and leukemia group B9182 study. J Clin Oncol 1999 Aug; 17(8): 2506-13
 
Tannock IF, de Wit R, Berry W, et al. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med 2004; 351(15): 1502-12.
 
Tannock IF, Osoba D, Stockler MR, et. al. Chemotherapy with mitoxantrone plus prednisone or prednisone alone for symptomatic hormone-resistant prostate cancer: a Canadian randomized trial with palliative end points. J Clin Oncol 1996 June; 14(6): 1756-64.

 

October 2017 Replaced regimen category with evidence-informed

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M - Disclaimer

Regimen Abstracts
A Regimen Abstract is an abbreviated version of a Regimen Monograph and contains only top level information on usage, dosing, schedule, cycle length and special notes (if available). It is intended for healthcare providers and is to be used for informational purposes only. It is not intended to constitute or be a substitute for medical advice, and all uses of the Regimen Abstract are subject to clinical judgment. Such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability, and Cancer Care Ontario disclaims all liability for the use of this information, and for any claims, actions, demands or suits that arise from such use.
Information in regimen abstracts is accurate to the extent of the ST-QBP regimen master listings, and has not undergone the full review process of a regimen monograph.  Full regimen monographs will be published for each ST-QBP regimen as they are developed.
Regimen Monographs
Refer to the New Drug Funding Program or Ontario Public Drug Programs websites for the most up-to-date public funding information.
The information set out in the drug monographs, regimen monographs, appendices and symptom management information (for health professionals) contained in the Drug Formulary (the "Formulary") is intended for healthcare providers and is to be used for informational purposes only. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects of a particular drug, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for a given condition. The information in the Formulary is not intended to constitute or be a substitute for medical advice and should not be relied upon in any such regard. All uses of the Formulary are subject to clinical judgment and actual prescribing patterns may not follow the information provided in the Formulary.
The format and content of the drug monographs, regimen monographs, appendices and symptom management information contained in the Formulary will change as they are reviewed and revised on a periodic basis. The date of last revision will be visible on each page of the monograph and regimen. Since standards of usage are constantly evolving, it is advised that the Formulary not be used as the sole source of information. It is strongly recommended that original references or product monograph be consulted prior to using a chemotherapy regimen for the first time.
Some Formulary documents, such as the medication information sheets, regimen information sheets and symptom management information (for patients), are intended for patients. Patients should always consult with their healthcare provider if they have questions regarding any information set out in the Formulary documents.
While care has been taken in the preparation of the information contained in the Formulary, such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability.
CCO and the Formulary’s content providers shall have no liability, whether direct, indirect, consequential, contingent, special, or incidental, related to or arising from the information in the Formulary or its use thereof, whether based on breach of contract or tort (including negligence), and even if advised of the possibility thereof. Anyone using the information in the Formulary does so at his or her own risk, and by using such information, agrees to indemnify CCO and its content providers from any and all liability, loss, damages, costs and expenses (including legal fees and expenses) arising from such person’s use of the information in the Formulary.