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regimen-monograph
EC+FILG; EC+FILG-TRAS
A - Regimen Name
EC+FILG Regimen
EPIrubicin-Cyclophosphamide plus G-CSF (Filgrastim)
EC+FILG-TRAS Regimen
EPIrubicin-Cyclophosphamide plus G-CSF (Filgrastim) followed by Trastuzumab
Disease Site
Breast
Intent
Neoadjuvant
Adjuvant
Adjuvant
Regimen Category
Archived : No longer in use and listed for reference purposes only, although the use of such a regimen may be appropriate in a situation where a Standard Regimen cannot be used for clinical reasons. Note: The Disease Site Group considers this regimen archived. It is listed for historical reference only and is no longer updated.
Rationale and Uses
Neoadjuvant treatment for non-metastatic breast cancer (inoperable locally advanced, inflammatory or to downsize tumour pre-surgery) or adjuvant therapy for node-positive and high risk node-negative breast cancer patients
Trastuzumab may be used after completion of EC+FILG if applicable (HER2-positive, adequate cardiac function). In addition, trastuzumab may be used for patients with node negative HER2 positive tumours 1mm - ≤1cm; LVEF must be ≥ 55% (>50 yrs) or ≥ 50% (≤50 yrs).
B - Drug Regimen
| EPIrubicin
(Round to nearest 1 mg) |
120 mg /m² | IV | Day 1 |
| cyclophosphamide
(Round to nearest 10 mg) |
830 mg /m² | IV | Day 1 |
| filgrastim | 5 mcg /kg/day | SC | Daily, on Days 2-13 |
|
For patients with HER2 positive tumours, Trastuzumab may be given for one year, starting after the completion of EC+FILG:
|
|||
C - Cycle Frequency
REPEAT EVERY 14 DAYS
Up to 6 cycles, unless disease progression or unacceptable toxicity occurs.
Trastuzumab: Refer to TRAS (Breast - Adjuvant) regimen for details.
D - Premedication and Supportive Measures
Antiemetic Regimen:
Moderate
Other Supportive Care:
- Filgrastim is administered as part of the regimen.
- Erythropoetin (titrated) was used in the clinical trial (MA.21).
E - Dose Modifications
Doses should be modified according to the protocol by which the patient is being treated. The following recommendations are in use at some centres.
Dosage with toxicity
Hematologic Toxicities: See Appendix 6 for general recommendations.
Worst Toxicity / Counts (x 109/L ) in Prior Cycle
|
Epirubicin (% previous dose) |
Cyclophosphamide (% previous dose)
|
Febrile Neutropenia, or Thrombocytopenic bleeding, or |
75% * |
75%*
|
Cardiotoxicity** |
Discontinue |
Caution |
Grade 3 related non-hematologic / organ |
75% for suspect drug(s) * |
|
Grade 4 related non-hematologic / organ |
Discontinue |
|
* Do not retreat until toxicity has recovered to ≤ grade 2 and platelets ≥ 100 x 109/L, and ANC ≥ 1.5 x 109/L.
** 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%. Consult drug monographs.
** 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%. Consult drug monographs.
Hepatic Impairment
| Bilirubin | AST/ALT | Epirubicin | Cyclophosphamide | |
|
(% of previous dose)
|
||||
|
1-2 x ULN
|
and/ or
|
-
|
50%
|
100%
|
|
2-4 x ULN
|
2-4x ULN
|
25%
|
Caution
|
|
|
>4 x ULN
|
>4 x ULN
|
Discontinue
|
Caution
|
|
Renal Impairment
Creatinine Clearance (mL/min) |
Epirubicin
(% previous dose) |
Cyclophosphamide (% previous dose) |
|
>30 – 50
|
100%
|
100%
|
|
10 – 30
|
consider dose ↓
|
50-75%
|
|
< 10
|
↓ dose
|
50% or OMIT
|
F - Adverse Effects
Refer to EPIrubicin, cyclophosphamide, filgrastim drug monograph(s) for additional details of adverse effects
Refer to trastuzumab drug monograph for adverse effect details (not listed below).\
Most Common Side Effects
|
Less Common Side Effects, but may be |
|
· Pneumonitis, pulmonary fibrosis
· SIADH, renal failure
· DIC, hemolytic uremic syndrome
· Secondary leukemia or cancers
· Thromboembolism
· Cardiotoxicity, arrhythmia
· Rhabdomyolysis
· Pancreatitis
|
I - Recommended Clinical Monitoring
Recommended Clinical Monitoring
- Clinical toxicity assessment (including stomatitis, diarrhea, infection, cardiotoxicity, pulmonary, local toxicity, cystitis).
- CBC 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 .
- Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version
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J - Administrative Information
Approximate Patient Visit
EC+FILG
1 hour
EC+FILG-TRAS
First cycle: 2.5 hours; Subsequent cycles: 1.5 hours
K - References
Burnell M, Levine MN, Chapman JAW, et al Cyclophosphamide, Epirubicin, and Fluorouracil Versus Dose-Dense Epirubicin and Cyclophosphamide Followed by Paclitaxel Versus Doxorubicin and Cyclophosphamide Followed by Paclitaxel in Node-Positive or High-Risk Node-Negative Breast Cancer. J Clin Oncol 2010; 28:77-82.
July 2012: Modified regimen category
PEBC Advice Documents or Guidelines
M - Disclaimer
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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Last Updated: July 21, 2026
