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.
DOXO
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.
Treatment of advanced breast cancer
REPEAT EVERY 21 DAYS
Until disease progression or unacceptable toxicity or cardiotoxicity risk limits use
Moderate (< 60 mg/m2)
High (≥ 60 mg/m2)
Other Supportive Care:
Also refer to CCO Antiemetic Recommendations.
Screen for hepatitis B virus in all cancer patients starting systemic treatment. Refer to the hepatitis B virus screening and management guideline.
Doses should be modified according to the protocol by which the patient is being treated.
Dosage with toxicity
Suggested dose levels: 75, 60, 50, 40 mg/m2.
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Worst Toxicity / Counts in Prior Cycle
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Doxorubicin Dose
for Next Cycle
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Febrile Neutropenia / Thrombocytopenic bleeding / ANC grade 4 ≥ 7 d
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↓ 1 dose level*
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Cardiotoxicity**
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Discontinue
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Grade 3 related organ
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↓ 1 dose level*
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Grade 4 related organ
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Discontinue
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*Do not start new cycle until organ toxicity ≤ grade 2, platelets ≥ 100 x 109/L and ANC ≥ 1.5 x 109/L
**including any signs and symptoms of heart failure, greater than 10% decline in LVEF to below the lower limit of normal, a greater than 20% decline in LVEF from any level, or LVEF ≤ 45%
Hepatic Impairment
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Bilirubin (µmol/L)
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AST/ALT
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% Usual Dose
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1-2 x ULN
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50%
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2-4 x ULN
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and/or
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5-10 x ULN
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25%
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> 4 x ULN
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and/or
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> 10 x ULN
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OMIT
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Renal Impairment
No dosage adjustment required.
Dosage in the Elderly
Use with caution.
Refer to DOXOrubicin drug monograph(s) for additional details of adverse effects
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Very common (≥ 50%) |
Common (25-49%) |
Less common (10-24%) |
Uncommon (< 10%), but may be severe or life-threatening |
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|
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Refer to DOXOrubicin drug monograph(s) for additional details
- Avoid use of calcium channel blockers (e.g. verapamil) or bevacizumab with doxorubicin due to additive cardiotoxicity.
- Avoid anthracycline-based therapy for up to 28 weeks after stopping trastuzumab.
- Avoid use of cyclosporine with doxorubicin if possible, as it may increase doxorubicin concentrations.
- Avoid using stavudine or zidovudine with doxorubicin.
- Monitor serum digoxin levels when used with doxorubicin; levels may decrease.
- Monitor serum phenytoin levels when used with doxorubicin; levels may decrease.
Refer to DOXOrubicin drug monograph(s) for additional details
Administration
- Slow push through sidearm of free flowing IV (5% Dextrose, Normal Saline). Depending on the dose volume and vein condition, administer the dose between 3 to 10 minutes to minimize thrombosis risk or extravasation.
- Do not admix with other drugs unless data are available; precipitates with fluorouracil and heparin.
- Avoid contact with alkaline solutions as this can lead to hydrolysis of doxorubicin.
- Slow down injection rate if erythematous streaking or facial flushing occurs.
- If any signs or symptoms of extravasation occur, the injection or infusion should be immediately terminated and restarted in another vein. Any known or suspected extravasation should be managed promptly as per local guidelines and should include application of ice to the affected area.
- Store vials under refrigeration (2 to 8ºC) and protect from light.
Contraindications:
- Patients who have a hypersensitivity to this drug or any of its components, other anthracyclines or anthracenediones (i.e. epirubicin, daunorubicin, mitoxantrone or mitomycin C)
- Persistent myelosuppression induced by chemotherapy or radiation
- Severe hepatic impairment
- Severe myocardial insufficiency, arrhythmias or history of cardiac disease or recent myocardial infarction
- Previous treatment with maximum cumulative doses of doxorubicin, other anthracyclines or anthracenediones
Precautions:
- Avoid the use of live vaccines; use may result in serious infections in immunocompromised patients
Pregnancy/Lactation:
- This regimen is not recommended for use in pregnancy. Adequate contraception should be used by patients and their partners while on treatment and after the last treatment dose. Recommended methods and duration of contraception may differ depending on the treatment. Refer to the drug monograph(s) for more information.
- Breastfeeding is not recommended during this treatment and after the last treatment dose. Refer to the drug monograph(s) for recommendations after the last treatment dose (if available).
- Fertility can be affected, by may be partially reversible.
Treating physicians may decide to monitor more or less frequently for individual patients but should always consider recommendations from the product monograph.
Refer to the hepatitis B virus screening and management guideline for monitoring during and after treatment.
Recommended Clinical Monitoring
- CBC; Baseline and before each cycle
- Liver function tests; Baseline and before each cycle
- Cardiac function tests (Echo, RNA and/or MUGA scans) for all patients with cardiac risk factors (including prior trastuzumab or patients at or above threshold dose levels); Baseline and as clinically indicated
- Clinical toxicity assessment for infection, bleeding, stomatitis, nausea, vomiting, injection site reactions, cardiac or dermatologic effects; At each visit
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Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version
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Carmo-Pereir J, Costa FO, Henriques E, et al. A comparison of two doses of adriamycin in the primary chemotherapy of disseminated breast carcinoma. Br J Cancer 1987 Oct; 56(4): 471-473.
Chan S, Friedrichs K, Noel D, et al. Prospective randomized trial of docetaxel versus doxorubicin in patients with metastatic breast cancer. J Clin Oncol 1999;17(8):2341-54.
Norris B, Pritchard KI, James K, et al. Phase III comparative study of vinorelbine combined with doxorubicin versus doxorubicin alone in disseminated metastatic/recurrent breast cancer: National Cancer Institute of Canada Clinical Trials Group Study MA8. J Clin Oncol 2000 June; Vol 18(12): 2385-2394.
Paridaens R, Biganzoli L, Bruning P, et al. Paclitaxel versus doxorubicin as first-line single-agent chemotherapy for metastatic breast cancer: a European Organization for Research and Treatment of Cancer randomized study with cross-over. J Clin Oncol 2000;18:724-33.
Doxorubicin drug monograph, Cancer Care Ontario.
October 2023 Modified Pregnancy/breastfeeding section
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.