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.
DOCE; DOCE+TRAS
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.
For the treatment of metastatic breast cancer
trastuzumab
New Drug Funding Program
(Trastuzumab (Biosimilar) in combination with Chemotherapy - Metastatic Breast Cancer)
(NDFP Website
)
trastuzumab
New Drug Funding Program
(Trastuzumab (Biosimilar) - Second Line - Metastatic Breast Cancer)
(NDFP Website
)
Note: Different trastuzumab products are NOT INTERCHANGEABLE.
| DOCEtaxel | 100 mg /m² | IV | Day 1 |
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For patients with HER2 positive tumours, trastuzumab may be given concurrently with docetaxel and then as a single agent. |
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| trastuzumab | 8 mg /kg | IV loading dose | Day 1, cycle 1 only |
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| trastuzumab | 6 mg /kg | IV maintenance dose | Every 21 days |
REPEAT EVERY 21 DAYS
• Until disease progression or unacceptable toxicity occurs
• For patients with HER2 positive tumours, trastuzumab may be given concurrently and then as a single agent. Refer to TRAS (Breast - Advanced) regimen for details.
Low
Other Supportive Care:
Also refer to CCO Antiemetic Summary
Screen for hepatitis B virus in all cancer patients starting systemic treatment. Refer to the hepatitis B virus screening and management guideline.
Docetaxel Pre-medications (prophylaxis for infusion reaction):
- Dexamethasone* 8 mg PO BID for 3 days, starting 1-day pre-infusion†
* Do not discontinue dexamethasone, even in the absence of an IR, due to the benefits on other adverse effects (e.g. pain and edema).
† Dexamethasone 10-20 mg IV can be given if patient forgot to take oral doses.
Doses should be modified according to the protocol by which the patient is being treated.
Patients should not be treated until they have recovered from prior toxicity and have acceptable blood counts (ANC ≥ 1.5 x 109/L and platelets ≥ 100 x 109/L).
Dosage with toxicity
See TRAS (Breast - Advanced) regimen for details on trastuzumab dose modifications.
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Toxicity (worst in previous cycle)
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Docetaxel (% of previous dose)* |
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Febrile neutropenia / Grade 4 ANC ≥ 7 d |
75%
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Grade 3 skin/ neuro/ major organ/ non-hematologic toxicity |
75%
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| Any occurrence of cystoid macular edema | Hold and investigate; refer patient promptly an ophthalmic examination. Discontinue if confirmed. |
| Grade 4 skin/ neuro/ major organ/ non-hematologic toxicity OR Recurrence of Grade 3 toxicity after prior dose reduction OR Any Severe Cutaneous Adverse Reactions (SCARs) (e.g. Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), Acute generalized exanthematous pustulosis (AGEP)) |
Discontinue
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* Do not retreat until ANC ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L, and non-hematologic / organ toxicity ≤ grade 2. |
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Management of Infusion-related reactions:
Also refer to the CCO guideline for detailed description of Management of Cancer Medication-Related Infusion Reactions.
Trastuzumab: Refer to the Trastuzumab drug monograph for details.
Docetaxel:
| Grade | Management | Re-challenge |
| 1 or 2 |
Restart:
|
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| 3 or 4 |
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Hepatic Impairment
Docetaxel: Patients with hepatic impairment have a higher risk of severe adverse effects, including fatal gastrointestinal hemorrhage, sepsis and myelosuppression.
| Bilirubin |
AST and/or ALT |
|
Alkaline Phosphatase |
Docetaxel dose |
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| > ULN | AND | Any | AND | Any |
Do not treat. Discontinue if treatment already started. |
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| Any | AND |
> 1.5 X ULN
|
AND |
> 2.5 x ULN |
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Trastuzumab: No adjustment required.
Renal Impairment
No adjustment required.
Dosage in the Elderly
For docetaxel, no adjustment required, but caution should be exercised in elderly patients with poor performance status.
For trastuzumab, no adjustment required; the risk of cardiac dysfunction and myelosuppression may be increased in elderly patients. The reported trials did not determine differences in efficacy between patients > 65 years versus younger patients.
Refer to DOCEtaxel (± Trastuzumab) drug monograph(s) for additional details of adverse effects.
See TRAS (Breast - Advanced) regimen for details on trastuzumab adverse effects.
Docetaxel:
|
Very common (≥ 50%) |
Common (25-49%) |
Less common (10-24%) |
Uncommon (< 10%), but may be severe or life-threatening |
|
|
|
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Refer to DOCEtaxel (± Trastuzumab) drug monograph(s) for additional details.
- Avoid concomitant use of docetaxel with CYP3A4 inhibitors. If must use together, consider decreasing docetaxel dose (50% for strong inhibitors).
- Avoid concurrent use of docetaxel with dronedarone.
- Avoid concomitant use of trastuzumab with anthracyclines and other cardiotoxic drugs. Use with extreme caution with anthracyclines for up to 28 weeks after stopping trastuzumab.
Refer to DOCEtaxel (± Trastuzumab) drug monograph(s) for additional details.
See TRAS (Breast - Advanced) regimen for details on trastuzumab Drug Administration and Special Precautions.
Administration - Docetaxel:
- Refer to the respective product monographs for preparation instructions. Mix in 250mL D5W or NS to a maximum concentration of 0.3-0.74 mg/mL. For doses over 200mg, use a larger volume of the infusion vehicle so the maximum concentration is not exceeded.
- Infuse through main IV line over 1 hour.
- In order to minimize patients' exposure to DEHP leaching from PVC bags or sets, use polyolefin or polypropylene infusion bags and polyethylene-lined administration sets.
- To minimize hypersensitivity reactions, docetaxel infusion should be started at a slow rate, then increased incrementally to planned rate.
- Monitor patient for signs of alcohol intoxication (due to alcohol content in formulation) during and after the infusion. Slowing the infusion rate during administration may help resolve symptoms.
- Injection site recall reactions (recurrence of skin reaction at a previous extravasation site after docetaxel is administered at a different site) have been observed.
Also refer to the CCO guideline for detailed description of Management of Cancer Medication-Related Infusion Reactions.
Contraindications - Docetaxel:
- Patients who have a history of hypersensitivity reactions to docetaxel, to other drugs formulated with polysorbate 80 or polyethylene glycol 300, or to any components of the formulation
- Patients with baseline neutrophil counts of <1.5 x 109/L
- Patients with severe liver impairment
Other Warnings/Precautions - Docetaxel:
- Use with caution in patients with pre-existing effusions or ascites.
- Use with caution in patients who have hypersensitivity to paclitaxel. Patients who have previously experienced a hypersensitivity reaction to paclitaxel may develop a potentially fatal hypersensitivity reaction to docetaxel.
- Docetaxel contains ethanol (refer to respective product monographs) and may cause drowsiness. Patients should be cautioned regarding driving and the use of machinery immediately after receiving the infusion. Ethanol may be harmful to patients at risk of adverse effects such as those with alcoholism, liver disease, epilepsy and children. Cases of alcohol intoxication have been reported.
Pregnancy/Lactation:
- DOCE and DOCE+TRAS regimens are contraindicated 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 contraindicated during treatment and after the last treatment dose. Refer to the drug monograph(s) for recommendations after the last treatment dose (if available).
- Fertility effects:
- Docetaxel: Fertility may be affected, especially in males.
- Trastuzumab: Unknown
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.
Also refer to TRAS (Breast - Advanced) regimen for details on monitoring.
Recommended Clinical Monitoring
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CBC, including nadir counts; baseline and before each cycle
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Liver function tests; baseline and before each cycle
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Clinical toxicity assessment of infection, bleeding, neurotoxicity, fluid retention, hypersensitivity, lethargy, cutaneous reactions, thromboembolism, musculoskeletal pain, secondary malignancies, cardiovascular, ophthalmic, GI or respiratory 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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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: 2341-54.
Docetaxel drug monograph, Ontario Health (Cancer Care Ontario).
Jones SE, Erban J, Overmoyer B, et al. Randomized phase III study of docetaxel compared with paclitaxel in metastatic breast cancer. J Clin Oncol. 2005 Aug 20;23(24):5542-51.
Nabholtz JM, Senn HJ, Bezwoda WR, et al. Prospective randomized trial of docetaxel versus mitomycin plus vinblastine in patients with metastatic breast cancer progressing despite previous anthracycline-containing chemotherapy. J Clin Oncol 1999;17:1413-24.
Trastuzumab drug monograph, Ontario Health (Cancer Care Ontario).
May 2024 Modified Pre-medications, Dose modifications, Adverse effects, Interactions, Drug Administration/Special Precautions, and Monitoring sections
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.
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