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.
FEC100
Neoadjuvant
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 therapy for node-positive and high risk node-negative early breast cancer
| fluorouracil | 500 mg /m² | IV | Day 1 |
| EPIrubicin | 100 mg /m² | IV | Day 1 |
| cyclophosphamide | 500 mg /m² | IV | Day 1 |
REPEAT EVERY 21 DAYS
For a usual total of 6 cycles unless disease progression or unacceptable toxicity occurs
High
Moderate
Doses should be modified according to the protocol by which the patient is being treated.
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
|
Toxicity Type / Counts x 109/L |
|
Toxicity Type / Counts x 109/L |
Fluorouracil
(% previous dose)
|
Epirubicin
(% previous dose)
|
Cyclophosphamide
(% previous dose)
|
|
|
ANC <1.5
|
Or
|
Platelet < 100
|
Hold *
|
|||
|
Febrile Neutropenia,
Or Grade 4 ANC ≥ 7 d
|
Or
|
Thrombocytopenic bleeding
|
Hold *, then 75%
(or consider GCSF – for isolated neutropenia) |
|||
|
ANC ≥ 1.5
|
And
|
Platelet ≥ 100
|
100%
|
|||
|
Cardiotoxicity**
|
|
|
Discontinue
|
Discontinue
|
Caution
|
|
|
Grade 3 related organ / non-hematologic
|
|
|
*75% for suspect drug(s) |
|||
|
Grade 4 related organ / non-hematologic
|
|
|
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
|
CrCl (mL/min) |
Fluorouracil
|
Epirubicin
|
Cyclophosphamide (% previous dose) |
|
>30 – 50
|
100%
|
100%
|
100%
|
|
10 – 30
|
consider dose ↓
|
50-75%
|
|
|
< 10
|
↓ dose
|
50% or OMIT
|
|
Refer to fluorouracil, EPIrubicin, cyclophosphamide drug monograph(s) for additional details of adverse effects
Bolus 5FU regimens have more myelosuppression and GI effects but less Hand-Foot Syndrome, compared to prolonged infusions.
| 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
- Baseline and regular liver and renal function tests and urinalysis
- Cardiac examination especially with risk factors (including prior therapy with doxorubicin, mitoxantrone or other cardiac drug), or a cumulative epirubicin dose of > 900mg/m2
- Clinical toxicity assessment (including stomatitis, 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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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.
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