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.
FEC50
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
|
fluorouracil
(Round to nearest 25 mg) | 500 mg /m² | IV | Day 1 |
|
EPIrubicin
(Round to nearest 1 mg) | 50 mg /m² | IV | Day 1 |
|
cyclophosphamide
(Round to nearest 10 mg) | 500 mg /m² | IV | Day 1 |
|
|
|||
Doses should be modified according to the protocol by which the patient is being treated. The following recommendations are in use at some centres.
Patients should be tested for DPD deficiency before starting treatment with fluorouracil. Refer to the DPD Deficiency Guidance for Clinicians for more information.
In patients with unrecognized DPD deficiency, acute, life-threatening toxicity may occur; if grade 2-4 acute toxicity develops, treatment should be stopped immediately and permanent discontinuation considered based on clinical assessment of the toxicities.
Dosage with toxicity
Hematologic Toxicities: See Appendix 6 for general recommendations.
| Worst Toxicity in Prior Cycle (Toxicity Type / Counts x 109/L) |
Fluorouracil |
Epirubicin (% previous dose) |
Cyclophosphamide (% previous dose) |
||
| Febrile Neutropenia, or Thrombocytopenic bleeding, or Grade 4 ANC ≥ 7 d |
75% * |
75% * |
75% * |
||
|
Cardiotoxicity ** |
Discontinue |
Discontinue |
Caution |
||
|
Grade 3 related non-hematologic/ organ |
75% for suspect drug(s)* |
||||
|
Grade 4 related non-hematologic/organ |
Discontinue |
||||
**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
|
AST/ALT |
|
Bilirubin |
Epirubicin (% previous) |
Fluorouracil (% previous) |
Cyclophosphamide (% previous) |
|
2-4 x ULN |
Or |
1-2 x ULN |
50% |
No change |
No change |
|
>4 X ULN |
Or |
2-4 X ULN |
25% |
No change |
Caution |
|
|
|
> 4 X ULN |
Discontinue |
Discontinue |
Caution |
Renal Impairment
|
Creatinine Clearance (mL/min) |
Cyclophosphamide (% previous dose) |
Fluorouracil (% previous dose) |
Epirubicin (% previous dose) |
|
>30-50 |
100% |
100% |
|
|
10-30 |
50-75% |
Consider ↓ dose |
|
|
<10 |
50% or OMIT |
↓ dose |
|
Refer to fluorouracil, EPIrubicin, cyclophosphamide drug monograph(s) for additional details of adverse effects
| Most Common Side Effects |
Less Common Side Effects, but may be |
|
|
Refer to fluorouracil, EPIrubicin, cyclophosphamide drug monograph(s) for additional details
Refer to fluorouracil, EPIrubicin, cyclophosphamide drug monograph(s) for additional details
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
- Liver and renal function tests; baseline and before each cycle
- Cardiac examination especially with risk factors (including prior therapy with doxorubicin, mitoxantrone, or other cardiotoxic drug), or a cumulative epirubicin dose of > 900mg/m2; baseline and as clinically indicated
- Clinical toxicity assessment (including GI, infection, cardiotoxicity, pulmonary, local toxicity, cystitis); at each visit
-
Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version
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Cyclophosphamide, epirubicin, fluorouracil drug monographs, Cancer Care Ontario.
Keiling R, Armand PP, Hurteloup P, et al, French FAC vs. FEC study in advanced breast cancer. Onkologie, 1986; 9 (Suppl 1): 8-10.
French Epirubicin Study Group. A prospective randomized trial comparing epirubicin monochemotherapy to two fluorouracil, cyclosphosphamide and epirubicin regimens differing in epirubicin dose in advanced breast cancer patients. J Clin Oncol, 1991; 9: 305-312.
Periti P, Pannuti F, et al, Combination chemotherapy with cyclophosphamide, fluorouracil, and either epirubicin or mitoxantrone: A comparative randomized multicentre study in metastatic breast carcinoma. Cancer Invest, 1991; 9: 249-255.
Italian Multicentre Breast Study with Epirubicin. Phase III randomized study of fluorouracil, epirubicin, and cyclophosphamide v fluorouracil, doxorubicin, and cyclophosphamide in advanced breast cancer: An Italian multicentre trial. J Clin Oncol, 1988; 6: 976-982.
April 2023 Updated DPD deficiency information in the Dose Modifications 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.