Les renseignements du Formulaire de médicaments s’adressent aux professionnels de la santé. Il ne s’agit pas d’un avis médical. Certains des renseignements, y compris ceux sur le financement des médicaments anticancéreux, ne s’appliquent pas à tous les patients. Les plans de traitement du cancer sont propres à chaque patient. Si vous êtes un patient, veuillez parler avec votre équipe soignante pour comprendre comment ces renseignements s’appliquent à vous.
CYCLDOCE; CYCLDOCE+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.
Treatment for node-positive and high risk node-negative early operable breast cancer.
Trastuzumab may be used concurrently with or after completion of CYCLDOCE in HER-2 positive breast cancer.
trastuzumab
New Drug Funding Program
(Trastuzumab (Biosimilar) - Adjuvant Treatment for Breast Cancer)
Note: Different trastuzumab products are not interchangeable.
| DOCEtaxel | 75 mg /m² | IV | Day 1 |
| cyclophosphamide | 600 mg /m² | IV | Day 1 |
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For patients with HER2 positive tumours, trastuzumab is given for one year starting either concurrently with or after completion of chemotherapy.
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| trastuzumab | |||
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Refer to TRAS (Breast - Adjuvant) regimen for details.
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REPEAT EVERY 21 DAYS
For total of 4 cycles unless unacceptable toxicity occurs
Trastuzumab: Refer to TRAS (Breast - Adjuvant) regimen for details.
Moderate
High
Primary prophylaxis with G-CSF is indicated for CYCLDOCE. Refer to the Febrile Neutropenia Guideline.
Other Supportive Care:
Dexamethasone 8 mg bid po for 3 days starting 1 day prior to docetaxel (prevent anaphylaxis / fluid retention.)- Trastuzumab: Refer to Trastuzumab drug monograph for full details.
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. See appendix 6 for general recommendations.
Suggested dose levels for docetaxel are 75 mg/m2, 55 mg/m2, 40 mg/m2
Suggested dose levels for cyclophosphamide are 600 mg/m2, 450 mg/m2, 300 mg/m2
See TRAS (Breast - Adjuvant) regimen for details on trastuzumab dose modifications.
Dosage with toxicity
|
Worst Toxicity Type / Counts x 109/L |
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Worst Toxicity Type / Counts x 109/L |
Cyclophosphamide*
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Docetaxel *
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Febrile Neutropenia or Grade 4 ANC ≥ 7 d |
Or |
Thrombocytopenic bleeding |
Hold* and ↓ 1 dose level (or consider GCSF – for isolated neutropenia) |
Hold * and ↓ 1 dose level
(or consider GCSF – for isolated neutropenia) |
|
Grade 3 rash |
Or |
Grade 3 neurotoxicity |
100% |
↓ 1 dose level.* Discontinue if recurs |
| Any occurrence of cystoid macular edema | No change | Hold and investigate; refer patient promptly to an ophthalmic examination. Discontinue if confirmed. | ||
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Other Grade 3 organ / non-hematologic |
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↓ 1 dose level* |
↓ 1 dose level* |
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Cystitis |
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Consider dose reduction |
No change |
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Grade 4 organ / non-hematologic |
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Discontinue |
Discontinue |
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* Major organ toxicity should have recovered to ≤ grade 2 , ANC ≥ 1.5 x 109/L and platelets ≥ 100 x 109/L prior to retreatment |
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Hepatic Impairment
| AST and/or ALT | ALP | Bilirubin | Cyclophosphamide (% usual dose) | Docetaxel (% usual dose) | |||
| Mild-moderate | > 1.5 x ULN | AND | > 2.5x ULN | No change | Do not treat | ||
| Severe | > 3.5 x ULN | OR | > 6x ULN | OR | > ULN | Caution | Do not treat. Discontinue if treatment already started. |
Renal Impairment
|
Creatinine Clearance (mL/min) |
Cyclophosphamide (% of previous) |
Docetaxel |
|
>50 |
100% |
100% |
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10-50 |
↓ 1 level |
100% |
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<10 |
↓ 2 levels or OMIT |
100% |
Dosage in the Elderly
For docetaxel, no adjustment required, but caution should be exercised in elderly patients with poor performance status.
For cyclophosphamide, no dose modification routinely required, but should be used with caution.
Refer to DOCEtaxel, cyclophosphamide, (± trastuzumab) drug monograph(s) for additional details of adverse effects.
The following adverse effects table is related to CYCLDOCE. Refer to trastuzumab drug monograph for additional details on trastuzumab.
| 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, cyclophosphamide (± trastuzumab) drug monograph(s) for additional details
Refer to DOCEtaxel, cyclophosphamide (± trastuzumab) drug monograph(s) for additional details
Note: Different trastuzumab products are not interchangeable.
See TRAS (Breast - Adjuvant) regimen for details on trastuzumab
Treating physicians may decide to monitor more or less frequently for individual patients but should always consider recommendations from the product monograph.
Recommended Clinical Monitoring
- CBC before each cycle
- Baseline and regular liver function tests
- Baseline and regular renal function tests and urinalysis
- Clinical toxicity assessment (including neurologic, musculoskeletal, hypersensitivity, GI, skin and nails, cystitis, fluid retention, infection, bleeding, fatigue, thromboembolism, musculoskeletal pain, ophthalmic, 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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Jones S, Holmes FA, O’Shaughnessy JO, et al. Docetaxel with cyclophosphamide is associated with an overall survival benefit compared with doxorubicin and cyclophosphamide: 7-year follow-up of US oncology research trial 9735. JCO 2009; 27(8): 1177-83.
Jones SE, Mavin MA, Holmes FA et al. Phase III trial comparing doxorubicin plus cyclophosphamide with docetaxel plus cyclophosphamide as adjuvant therapy for operable breast cancer. JCO 2006; 24: 5381-7.
Cyclophosphamide, docetaxel, trastuzumab drug monographs, Cancer Care Ontario.
February 2022 Removed trastuzumab EBP forms; updated Rationale and uses 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.