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.

regimen-monograph

A - Regimen Name

EC+FILG-PACL Regimen
EPIrubicin-Cyclophosphamide plus G-CSF (Filgrastim) followed by PACLitaxel
EC+FILG-PACL+TRA Regimen
EPIrubicin-Cyclophosphamide plus G-CSF (Filgrastim) followed by PACLitaxel and Trastuzumab


Disease Site
Breast

Intent
Adjuvant

Regimen Category
Local : A regimen not widely used by Regional Cancer Centres in this disease site.

Rationale and Uses
Adjuvant therapy for node-positive and high risk node-negative breast cancer patients
 
B - Drug Regimen

EC+FILG (x 6 cycles):

EPIrubicin

(Round to nearest 1mg)
120 mg /m² IV Day 1
cyclophosphamide

(Round to nearest 10mg)
830 mg /m² IV Day 1
filgrastim
5 mcg /kg SC Daily, on Days 2-13

THEN

Paclitaxel (Taxol®) (x 4 cycles):

PACLitaxel

(Round to nearest 3mg)
175 mg /m² IV Day 1
filgrastim
5 mcg /kg SC Daily, on Days 2-13
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C - Cycle Frequency

EC+GCSF: REPEAT EVERY 14 DAYS
For 6 cycles

Followed by

Paclitaxel: REPEAT EVERY 21 DAYS
For 4 cycles

(For patients with HER2 positive tumours, trastuzumab may be given for one year either concurrently with paclitaxel or after completion of EC+FILG-PACL). Refer to TRAS regimen for details.)

 
D - Premedication and Supportive Measures

Antiemetic Regimen:

Moderate (EC)
Low (Paclitaxel)

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 in Prior Cycle (counts x 109/L Epirubicin (% previous dose) Cyclophosphamide (% previous dose) Paclitaxel (% previous dose)
Febrile Neutropenia
Thrombocytopenic bleeding
Grade 4 ANC ≥7 d
75%* 75%* 75%*
Cardiotoxicity** Discontinue Caution Caution or discontinue
Grade 3 related non-hematologic / organ 75% for suspect drug(s)*
Grade 4 related non-hematologic / organ  Discontinue  

*Do not start new cycle 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.



Hepatic Impairment

Bilirubin

 

AST/ALT

Epirubicin

Cyclophosphamide

Paclitaxel

(% of previous / mg/m2)

1-2 x ULN

and/ or

-

50%

100%

100%

2-4 x ULN

2-4x ULN

25%

 Caution

135mg/m2

>4 x ULN

>4 x ULN

Discontinue

Caution

50mg/m2 or OMIT

 


Renal Impairment

Creatinine Clearance (mL/min)

Epirubicin
(% previous dose)           
Cyclophosphamide
(% previous dose)

Paclitaxel

>30 – 50

 

100%

 

100%

No dose adjustment required

10 – 30

 

consider dose ↓

50-75%

< 10

 

↓ dose

50% or OMIT

 


 


 
F - Adverse Effects
Refer to EPIrubicin, cyclophosphamide, filgrastim, PACLitaxel drug monograph(s) for additional details of adverse effects

Most Common Side Effects 

Less Common Side Effects, but may be
Severe or Life-Threatening

  • Anorexia
  • Nausea and vomiting
  • Cystitis
  • Myelosuppression ± infection , bleeding
  • Stomatitis and diarrhea
  • Neurotoxicity
  • Hypersensitivity reactions (Paclitaxel)
  • Myalgia and arthralgia
  • Alopecia
  • Fatigue
  • Reproductive risks
  • ↑ LFTs
  • Pneumonitis, pulmonary fibrosis
  • SIADH, renal failure
  • DIC, hemolytic uremic syndrome
  • Secondary leukemia or cancers
  • Venous/arterial thromboembolism
  • Cardiotoxicity, arrhythmia
  • Rhabdomyolysis
  • Pancreatitis, GI obstruction, perforation

 

 
G - Interactions
Refer to EPIrubicin, cyclophosphamide, filgrastim, PACLitaxel drug monograph(s) for additional details
 
H - Drug Administration and Special Precautions
Refer to EPIrubicin, cyclophosphamide, filgrastim, PACLitaxel drug monograph(s) for additional details
 
I - Recommended Clinical Monitoring

Recommended Clinical Monitoring

  • Clinical toxicity assessment (including stomatitis, diarrhea, infection, cardiotoxicity, pulmonary, local toxicity, cystitis, neurologic, musculoskeletal).
  • 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-PACL
EC: 1 hour; PACL: 5 hours
EC+FILG-PACL+TRA
EC: 1 hour; PACL: 5 hours; TRAS: 1.5 hours (1st cycle); 0.5 hour (subsequent cycles)
 
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.

October 2017 Removed link to archived PEBC guideline


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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 27, 2026