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.
AC-DOCE; AC-DOCE+TRAS
Adjuvant
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.
Neo-adjuvant or adjuvant treatment for node-positive and high risk node-negative early breast cancer.
Trastuzumab may be used concurrently with docetaxel or after completion of docetaxel 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.
AC: (x 4 cycles)
DOXOrubicin
(Round to nearest 1mg) | 60 mg /m² | IV | Day 1 |
cyclophosphamide
(Round to nearest 10mg) | 600 mg /m² | IV | Day 1 |
THEN Docetaxel (Taxotere®): (x 4 cycles) |
|||
DOCEtaxel
(Round to nearest 5mg) | 100 mg /m² | IV | Day 1 |
|
|||
trastuzumab | |||
Refer to TRAS (Breast - Adjuvant) regimen for details.
|
REPEAT EVERY 21 DAYS
AC X 4 cycles then Docetaxel (Taxotere®) X 4 cycles
Trastuzumab: Refer to TRAS (Breast - Adjuvant) regimen for details.
High (AC)
Low (Docetaxel)
High
Consider G-CSF prophylaxis for patients at high risk of febrile neutropenia. See G-CSF recommendations.
Other Supportive Care:
- With docetaxel cycles: Dexamethasone 8 mg bid po for 3 days starting 1 day prior to docetaxel (prevent anaphylaxis / fluid retention.)
- With docetaxel, consider antibiotic prophylaxis or G-CSF according to local guidelines
- 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 TRAS (Breast - Adjuvant) regimen for details on trastuzumab dose modifications.
Dosage with toxicity
Worst Toxicity Type / Counts x 109/L |
|
Worst Toxicity Type / Counts x 109/L |
Doxorubicin (% previous dose)
|
Cyclophosphamide (% previous dose) |
Docetaxel (% previous dose) |
|
ANC < 0.5 |
Or |
Thrombocytopenic bleeding |
Hold*, then 75% (or consider GCSF – for isolated neutropenia) |
Hold*, then 75% (or consider GCSF – for isolated neutropenia) |
||
Grade 3 Neurotoxicity |
or |
Grade 3 skin toxicity |
Not applicable |
75%*;
|
||
Cystoid macular edema
|
Not applicable |
Hold and investigate; refer patient promptly an ophthalmic examination. Discontinue if confirmed.
|
||||
Worst Toxicity Type / Counts x 109/L | Worst Toxicity Type / Counts x 109/L | Doxorubicin (% previous dose) |
Cyclophosphamide (% previous dose) |
Docetaxel (% previous dose) |
||
Other Grade 3 related organ / non-hematologic |
|
|
75%* for suspect drug(s). If cardiotoxicity, follow recommendations in doxorubicin drug monograph. |
|||
Grade 4 related organ / non-hematologic |
|
Discontinue |
Hepatic Impairment
|
AST and/or ALT
|
|
Alk Phosp
|
Cyclophosphamide (% previous)
|
Doxorubicin (% previous)
|
Docetaxel (% previous)
|
Mild-moderate
|
> 1.5 -3.5 X ULN
|
AND
|
> 2.5 to 6 x ULN
|
100%; caution with moderate hepatic impairment | 50-75% |
Do not treat
|
Severe
|
> 3.5 x ULN
|
OR
|
> 6 x ULN
|
Caution | Discontinue |
Do not treat. Discontinue* if treatment already started.
|
Renal Impairment
Creatinine Clearance (mL/min) |
DOXOrubicin (% previous dose) |
cyclophosphamide (% previous dose) |
DOCEtaxel (% previous dose) |
>50 |
No change |
100% |
No change |
10-50 |
No change |
75% |
No change |
<10 |
No change |
Use with extreme caution or discontinue |
No change |
Dosage in the Elderly
No dosage adjustment required, but caution should be exercised in elderly patients with poor performance status who are receiving docetaxel.
The risk of cardiac dysfunction and myelosuppression may be increased in elderly patients on trastuzumab. The reported trials did not determine differences in efficacy between patients > 65 years versus younger patients.
Refer to DOXOrubicin, cyclophosphamide, DOCEtaxel (± trastuzumab) drug monograph(s) for additional details of adverse effects
Most Common Side Effects |
Less Common Side Effects, but may be |
|
|
Refer to DOXOrubicin, cyclophosphamide, DOCEtaxel (± trastuzumab) drug monograph(s) for additional details
Refer to DOXOrubicin, cyclophosphamide, DOCEtaxel (± trastuzumab) drug monograph(s) for additional details
Note: Different trastuzumab products are not interchangeable.
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; baseline and before each cycle
- Baseline and regular liver function tests
- Baseline and regular renal function tests and urinalysis
- Cardiac examination especially with risk factors (including prior therapy with Epirubicin, Mitoxantrone, or other cardiotoxic drug), or a cumulative Doxorubicin dose of > 450 mg/m2
- Clinical toxicity assessment (including stomatitis, cardiotoxicity, local toxicity, cystitis, neurologic, infection, bleeding, skin and nails, hypersensitivity, GI, respiratory, fatigue, fluid retention, ophthalmic, musculoskeletal pain, thromboembolism); at each visit
-
Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version
back to top
Bear HD, Anderson S, Brown A, et al. The effect on tumor response of adding sequential preoperative docetaxel to preoperative doxorubicin and cyclophosphamide: preliminary results from National Surgical Adjuvant Breast and Bowel Project Protocol B-27. J Clin Oncol 2003;21(22):4165-74.
Eiermann W, Pienkowski T, Crown J, et al. Phase III study of doxorubicin/cyclophosphamide with concomitant versus sequential docetaxel as adjuvant treatment in patients with human epidermal growth factor receptor 2-normal, node-positive breast cancer: BCIRG-005 trial. J Clin Oncol 2011;29(29):3877-84.
Slamon D, Eiermann W, Robert N, et al. Adjuvant trastuzumab in HER2-positive breast cancer. N Engl J Med 2011;365(14):1273-83.
Swain SM, Jeong JH, Geyer CE Jr, et al. Longer therapy, iatrogenic amenorrhea, and survival in early breast cancer. N Engl J Med 2010;362(22):2053-65.
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.