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.
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regimen-monograph
DOXO
A - Regimen Name
DOXO Regimen
DOXOrubicin
Disease Site
Gynecologic - Uterine Sarcoma
(including Leiomyosarcoma of the Uterus - LMS)
(including Leiomyosarcoma of the Uterus - LMS)
Intent
Palliative
Regimen Category
Standard : Standard therapy endorsed by the Disease Site Group or a regimen widely used by most Regional Cancer Centres in this disease site. The category is unrelated to the source or availability of funding.
Rationale and Uses
First and/or second-line treatment of inoperable locally advanced, recurrent or metastatic uterine sarcoma (including LMS). Data supporting the use of this regimen are from single arm studies or studies which do not include a "no treatment" arm.
B - Drug Regimen
| DOXOrubicin
(Round to nearest 1 mg) |
60-80 mg /m² | IV | Day 1 |
|
May consider a lower starting dose in patients > 65 years of age, or who had completed external radiotherapy within 6 months, or those with poor performance status.
|
|||
C - Cycle Frequency
REPEAT EVERY 21 DAYS
For a Usual Total of 6 to 8 Cycles, unless disease progression, unacceptable toxicity or limited by cardiotoxicity risk
E - Dose Modifications
Doses should be modified according to the protocol by which the patient is being treated. The following recommendations have been adapted from clinical trials or product monographs and could be considered.
Dosage with toxicity
Hematologic Toxicities: See Appendix 6 for general recommendations. Suggested dose levels: 80, 60, 45, 30 mg/m2.
|
Worst Toxicity / Counts in Prior Cycle
|
Doxorubicin Dose
for Next Cycle
(% previous dose)
|
|
Febrile Neutropenia / Thrombocytopenic bleeding / AGC grade 4 ≥ 7 d
|
↓ 2 dose levels* #
|
|
Cardiotoxicity**
|
Discontinue
|
|
Grade 3 related organ
|
↓ 1 dose level*
|
|
Grade 4 related organ
|
Discontinue
|
*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%
# Consider G-CSF use instead of dose reduction if appropriate
**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%
# Consider G-CSF use instead of dose reduction if appropriate
Hepatic Impairment
|
Bilirubin (µmol/L)
|
|
AST/ALT
|
% Usual Dose
|
|
1-2 x ULN
|
|
|
50%
|
|
2-4 x ULN
|
±
|
5-10 x ULN
|
25%
|
|
4-10 x ULN
|
±
|
> 10 x ULN
|
OMIT
|
Renal Impairment
No adjustment required.
F - Adverse Effects
Refer to DOXOrubicin drug monograph(s) for additional details of adverse effects
Most Common Side Effects |
Less Common Side Effects, but may be Severe or Life-Threatening |
|
|
H - Drug Administration and Special Precautions
Refer to DOXOrubicin drug monograph(s) for additional details
I - Recommended Clinical Monitoring
Recommended Clinical Monitoring
- CBC; baseline and regular
- Cardiac function tests (Echo, RNA and/or MUGA scans) for all patients with cardiac risk factors; baseline
- Cardiac tests for all patients with cardiac risk factors (including prior trastuzumab, anthracyclines, mitoxantrone, other cardiotoxic drugs, or patients at or above the threshold dose levels - 400mg/m2 for q21 day schedules); periodic
- Liver function tests; baseline and regular
- Clinical assessment of stomatitis, bleeding, infection, local toxicity, cardiotoxicity, thromboembolism
- Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version
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K - References
Muss HB, Bundy B, DiSaia PJ, et al. Treatment of recurrent or advanced uterine sarcoma. A randomized trial of doxorubicin versus doxorubicin and cyclophosphamide (a phase III trial of the Gynecologic Oncology Group). Cancer 1985;55:1648-53.
Omura GA, Major FJ, Blessing JA, et al. A randomized study of adriamycin with and without dimethyl triazenoimidazole carboxamide in advanced uterine sarcomas. Cancer 1983;52:626-32.
PEBC Advice Documents or Guidelines
October 2017 Removed archived PEBC link
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.
Last Updated: July 27, 2026
