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Breast neoadjuvant D (DOCEtaxel) (part 2 of FEC-D)

This protocol is based on limited evidence; please refer to the evidence section of this protocol for more information.

Check for clinical trials in this patient group. Link to Australian Clinical Trials website

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Cycle 1 to 3

Drug Dose Route Day
DOCEtaxel 100 mg/m2 * IV infusion 1
Frequency:
21 days 
Cycles:
3 or 4 *(The phase II trials supporting this regimen used 4 cycles of FEC followed by 4 cycles of docetaxel 75 mg/m2. Given that OS and DFS are essentially equivalent whether chemotherapy is given in the adjuvant or neoadjuvant setting, there are arguments for using either 3 to 4 cycles of FEC followed by 3 to 4 cycles of docetaxel. It is the consensus of the reference committee that 3 to 4 cycles of docetaxel 100 mg/m2 be used for part 2 of the FEC-D regimen)
Notes:
Drug status:

Docetaxel in on the PBS general schedule

Cost:
~ $130 per cycle "How this cost is calculated"

The cost displayed on the protocol is intended as rudimentary guide only for the Australian context.

The cost includes antineoplastic drugs only (not antiemetics or other supportive medications), unless otherwise indicated.

Drug unit costs are taken directly from the Pharmaceutical Benefits Scheme (PBS) website (www.pbs.gov.au), MIMS Online and other sources. These costs are reviewed and updated on eviQ at 6 monthly intervals.

Where there are differing unit costs based on vial sizes and tablet strengths, the mean unit cost is used. The cost of oral continuous therapy is based on 28 day month.

The protocol cost is derived from drug dose calculations based upon a default body surface area (BSA) of 1.8 m2; weight of 75 kg; and creatinine clearance of 75 mL/min.

One off loading doses are not included in protocol cost calculations.

The cost displayed is the actual drug cost and does not necessarily reflect the cost incurred by the patient as many antineoplastic drugs are reimbursed on the PBS.

The supportive therapies (e.g. antiemetics, premedications, etc.), infusion times, diluents, volumes and routes of administration, if included, are listed as defaults. They may vary between institutions and can be substituted to reflect individual institutional policy.

Antiemetics if included in the treatment schedule are based upon recommendations from national and international guidelines. These are defaults only and may be substituted to reflect individual institutional policy. Select here for recommended doses of alternative antiemetics.

Cycle 1 to 3

Day before chemotherapy
Dexamethasone 8 mg (PO) TWICE a day with or after food
Day 1
Dexamethasone 8 mg (PO) TWICE a day with or after food
DOCEtaxel 100 mg/m2 (IV infusion) in 250 mL to 500 mL sodium chloride 0.9% over 60 minutes
Day 2
Dexamethasone 8 mg (PO) TWICE a day with or after food
Frequency:
21 days 
Cycles:
3 or 4 *(The phase II trials supporting this regimen used 4 cycles of FEC followed by 4 cycles of docetaxel 75 mg/m2. Given that OS and DFS are essentially equivalent whether chemotherapy is given in the adjuvant or neoadjuvant setting, there are arguments for using either 3 to 4 cycles of FEC followed by 3 to 4 cycles of docetaxel. It is the consensus of the reference committee that 3 to 4 cycles of docetaxel 100 mg/m2 be used for part 2 of the FEC-D regimen)

Cycle 1 to 3

Drug Dose Route Day
DOCEtaxel 100 mg/m2 * IV infusion 1
Frequency:
21 days 
Cycles:
3 or 4 *(The phase II trials supporting this regimen used 4 cycles of FEC followed by 4 cycles of docetaxel 75 mg/m2. Given that OS and DFS are essentially equivalent whether chemotherapy is given in the adjuvant or neoadjuvant setting, there are arguments for using either 3 to 4 cycles of FEC followed by 3 to 4 cycles of docetaxel. It is the consensus of the reference committee that 3 to 4 cycles of docetaxel 100 mg/m2 be used for part 2 of the FEC-D regimen)
Notes:
Drug status:

Docetaxel in on the PBS general schedule

Cost:
~ $130 per cycle "How this cost is calculated"

The cost displayed on the protocol is intended as rudimentary guide only for the Australian context.

The cost includes antineoplastic drugs only (not antiemetics or other supportive medications), unless otherwise indicated.

Drug unit costs are taken directly from the Pharmaceutical Benefits Scheme (PBS) website (www.pbs.gov.au), MIMS Online and other sources. These costs are reviewed and updated on eviQ at 6 monthly intervals.

Where there are differing unit costs based on vial sizes and tablet strengths, the mean unit cost is used. The cost of oral continuous therapy is based on 28 day month.

The protocol cost is derived from drug dose calculations based upon a default body surface area (BSA) of 1.8 m2; weight of 75 kg; and creatinine clearance of 75 mL/min.

One off loading doses are not included in protocol cost calculations.

The cost displayed is the actual drug cost and does not necessarily reflect the cost incurred by the patient as many antineoplastic drugs are reimbursed on the PBS.

The supportive therapies (e.g. antiemetics, premedications, etc.), infusion times, diluents, volumes and routes of administration, if included, are listed as defaults. They may vary between institutions and can be substituted to reflect individual institutional policy.

Antiemetics if included in the treatment schedule are based upon recommendations from national and international guidelines. These are defaults only and may be substituted to reflect individual institutional policy. Select here for recommended doses of alternative antiemetics.

Cycle 1 to 3

Day before chemotherapy
Dexamethasone 8 mg (PO) TWICE a day with or after food
Day 1
Dexamethasone 8 mg (PO) TWICE a day with or after food
DOCEtaxel 100 mg/m2 (IV infusion) in 250 mL to 500 mL sodium chloride 0.9% over 60 minutes
Day 2
Dexamethasone 8 mg (PO) TWICE a day with or after food
Frequency:
21 days 
Cycles:
3 or 4 *(The phase II trials supporting this regimen used 4 cycles of FEC followed by 4 cycles of docetaxel 75 mg/m2. Given that OS and DFS are essentially equivalent whether chemotherapy is given in the adjuvant or neoadjuvant setting, there are arguments for using either 3 to 4 cycles of FEC followed by 3 to 4 cycles of docetaxel. It is the consensus of the reference committee that 3 to 4 cycles of docetaxel 100 mg/m2 be used for part 2 of the FEC-D regimen)
  • Neoadjuvant treatment of operable breast cancer.
Venous access required

IV cannula (IVC) or central venous access device (CVAD) is required to administer this treatment.

Read more about central venous access device line selection
Hypersensitivity/infusion related reaction

High risk with docetaxel
Premedication

The product information states that premedication is required for this treatment.
Please refer to the treatment schedule for the suggested premedication regimen.
This may be substituted to reflect institutional policy.

Read more about premedication for prophylaxis of taxane hypersensitivity reactions
Emetogenicity LOW

Dexamethasone has been included as both an antiemetic and premedication for hypersensitivity in this protocol.

Ensure that patients also have sufficient antiemetics for breakthrough emesis:

Metoclopramide 10 mg three times a day when necessary (maximum of 30 mg/24 hours, up to 5 days) OR

Prochlorperazine 10 mg PO or 12.5 mg IV every 6 hours when necessary.

Read more about preventing antineoplastic induced nausea and vomiting
Peripheral neuropathy

Assess prior to each treatment. If a patient experiences grade 2 or greater peripheral neuropathy, a dose reduction, delay, or omission of treatment may be required; review by medical officer before commencing treatment.

Read more about peripheral neuropathy

Link to chemotherapy-induced peripheral neuropathy screening tool
Growth factor support

G-CSF (filgrastim, lenograstim, lipegfilgrastim or pegfilgrastim) may be required to maintain the schedule of this protocol. G-CSF is not available on the PBS for this protocol.

Access the PBS website
Blood tests

FBC, EUC and LFTs at baseline and prior to each treatment. Nadir FBC cycle 1.
Hepatitis B screening and prophylaxis

Routine screening for HBsAg and anti-HBc is recommended prior to initiation of treatment. Prophylaxis should be determined according to individual institutional policy. 

Read more about hepatitis B screening and prophylaxis in cancer patients requiring cytotoxic and/or immunosuppressive therapy
Vaccinations

Live vaccines, including BCG, MMR, zoster and varicella vaccines, are contraindicated in cancer patients receiving immunosuppressive therapy and/or who have poorly controlled malignant disease.

Refer to the recommended schedule of vaccination for immunocompromised patients, as outlined in the Australian Immunisation Handbook.
Effects of cancer treatment on fertility

Cancer treatment can have harmful effects on fertility and this should be discussed with all patients of reproductive age prior to commencing treatment.

Read more about the effect of cancer treatment on fertility
Evidence for dose modifications is limited, and the recommendations made on eviQ are intended as a guide only. They are generally conservative with an emphasis on safety. Any dose modification should be based on clinical judgement, and the individual patient’s situation including but not limited to treatment intent (curative vs palliative), the antineoplastic regimen (single versus combination therapy versus chemotherapy versus immunotherapy), biology of the cancer (site, size, mutations, metastases), other treatment related side effects, additional co-morbidities, performance status and patient preferences. Suggested dose modifications are based on clinical trial findings, product information and reference committee consensus. Non-haematological gradings are based on Common Terminology Criteria for Adverse Events (CTCAE) unless otherwise specified. Renal and hepatic dose modifications have been standardised where possible. For more information see dosing considerations & disclaimer.

Note:

  • All dose reductions are calculated as a percentage of the starting dose.
  • Administration of granulocyte colony-stimulating factor (G-CSF +/- antibiotics) is at clinician discretion and local hospital guidelines.
Haematological toxicity
ANC x 109/L (pre-treatment blood test)
0.5 to less than 1.0 Delay treatment until recovery and consider adding G-CSF for subsequent cycles
less than 0.5 Delay treatment until recovery and consider adding G-CSF for subsequent cycles;
If patient is already on G-CSF, consider reducing docetaxel by 25% for subsequent cycles
Febrile neutropenia Delay treatment until recovery and consider adding G-CSF for subsequent cycles;
If patient is already on G-CSF, consider reducing docetaxel by 25% for subsequent cycles
Platelets x 109/L (pre-treatment blood test) 
75 to less than 100 Refer to local institutional guidelines; it is the view of the expert clinicians that treatment should continue if patient is clinically well
50 to less than 75 Delay treatment until recovery
less than 50 Delay treatment until recovery and consider reducing docetaxel by 25% for subsequent cycles
Renal impairment
No dose modifications necessary
Hepatic impairment
Hepatic dysfunction
Minimal Reduce docetaxel by 25%
Mild Reduce docetaxel by 50%
Moderate/Severe Omit docetaxel
Peripheral neuropathy
Grade 2 which is present at the start of the next cycle Reduce docetaxel by 25%,
if persistent, reduce docetaxel by 50%
Grade 3 or Grade 4 Omit docetaxel
Mucositis and stomatitis
Grade 2 Delay treatment until toxicity has resolved to Grade 1 or less and reduce the dose for subsequent cycles as follows:
1st occurrence: No dose reduction
2nd occurrence: Reduce docetaxel by 25%
3rd occurrence: Reduce docetaxel by 50%
Grade 3 or Grade 4 Delay treatment until toxicity has resolved to Grade 1 or less and reduce the dose for subsequent cycles as follows:
1st occurrence: Reduce docetaxel by 50%
2nd occurrence: Omit docetaxel

References & Disclaimer

Docetaxel
  Interaction Clinical management
CYP3A4 and P-gp inhibitors (e.g. amiodarone, aprepitant, azole-antifungals, ritonavir, lapatinib, nilotinib, sorafenib, macrolides, ciclosporin, grapefruit juice etc.) Increased toxicity of docetaxel possible due to reduced clearance Avoid combination or monitor for docetaxel toxicity
CYP3A4 inducers (e.g. carbamazepine, phenytoin, phenobarbitone, rifampicin, St John’s wort etc.) Reduced efficacy of docetaxel possible due to increased clearance Avoid combination or monitor for decreased clinical response to docetaxel
General
  Interaction Clinical management
Warfarin Antineoplastic agents may alter the anticoagulant effect of warfarin Monitor INR regularly and adjust warfarin dosage as appropriate; consider alternative anticoagulant (e.g. LMWH or unfractionated heparin)
Direct oral anticoagulants (DOACs) e.g. apixaban, rivaroxaban, dabigatran

Interaction with both CYP3A4 and P-gp inhibitors /inducers.

DOAC and antineoplastic levels may both be altered, possibly leading to loss of efficacy or toxicity (i.e. increased bleeding).

Apixaban: avoid concurrent use with strong CYP3A4 and P‑gp inhibitors. If treating VTE, avoid use with strong CYP3A4 and P‑gp inducers. 

Rivaroxaban: avoid concurrent use with strong CYP3A4 and P‑gp  inhibitors.

Dabigatran: avoid combination with strong P‑gp inducers and inhibitors.

If concurrent use is unavoidable, monitor closely for efficacy/toxicity of both drugs.
Digoxin Antineoplastic agents can damage the lining of the intestine; affecting the absorption of digoxin Monitor digoxin serum levels; adjust digoxin dosage as appropriate
Antiepileptics Both altered antiepileptic and antineoplastic levels may occur, possibly leading to loss of efficacy or toxicity Where concurrent use of an enzyme-inducing antiepileptic cannot be avoided, monitor antiepileptic serum levels for toxicity, as well as seizure frequency for efficacy; adjust dosage as appropriate.
Also monitor closely for efficacy of the antineoplastic therapy
Antiplatelet agents and NSAIDs Increased risk of bleeding due to treatment related thrombocytopenia Avoid or minimise combination.
If combination deemed essential, (e.g. low dose aspirin for ischaemic heart disease) monitor for signs of bleeding
Serotonergic drugs, including selective serotonin reuptake inhibitors (SSRIs e.g. paroxetine) and serotonin noradrenaline reuptake inhibitors (SNRIs e.g. venlafaxine) Increased risk of serotonin syndrome with concurrent use of 5-HT3 receptor antagonists (e.g. palonosetron, ondansetron, granisetron, tropisetron, dolasetron, etc.) Avoid combination.
If combination is clinically warranted, monitor for signs and symptoms of serotonin syndrome (e.g. confusion, agitation, tachycardia, hyperreflexia).
For more information link to TGA Medicines Safety Update
Vaccines Diminished response to vaccines and increased risk of infection with live vaccines Live vaccines (e.g. BCG, MMR, zoster and varicella) are contraindicated in patients on immunosuppressive therapy. Use with caution in patients on non-immunosuppressive therapy.
For more information; refer to the recommended schedule of vaccination for cancer patients, as outlined in the Australian Immunisation Handbook

Day 1

Approximate treatment time: 90 minutes

General patient assessment prior to each day of treatment.

Peripheral neuropathy assessment tool

Any toxicity grade 2 or greater may require dose reduction, delay or omission of treatment and review by medical officer before commencing treatment.

Prime IV line(s).

Insert IV cannula or access port or CVC.

Pre treatment medication

Verify taxane premedication taken or administer as prescribed.

Administer antiemetics if required

Docetaxel

Prior to administration:
  • assess patient for fluid retention or weight gain prior to each cycle
    • notify medical officer of any signs of fluid retention or unexplained weight gain.

The medicines information reference publications stipulate the use of non-PVC containing bags and administration sets. However, this is not consistently recommended in the product information, therefore the decision should be at the discretion of the administering unit.

Administer docetaxel  (irritant with vesicant properties):
  • via IV infusion over 60 minutes
  • observe for hypersensitivity reactions
  • flush with ~ 100 mL of sodium chloride 0.9%.

Stop infusion at first sign of reaction:

  • if symptoms are mild and resolve when infusion is stopped, consider recommencing infusion after review by medical officer at a slower rate.
  • for severe reactions seek medical assistance immediately and do not restart infusion.

Remove IV cannula and/or deaccess port or CVC.

Continue safe handling precautions until 7 days after completion of drug(s)

Discharge information

Antiemetics
  • Antiemetics as prescribed.
Dexamethasone tablets
  • Dexamethasone tablets with written instructions on how to take them.
Growth factor support
  • Arrangements for administration if prescribed.
Patient information
  • Ensure patient receives patient information sheet.
Neoadjuvant chemotherapy (breast cancer) patient information sheet

The side effects listed below are not a complete list of all possible side effects for this treatment. Side effects are categorised into the approximate onset of presentation and should only be used as a guide.

Immediate (onset hours to days)
Hypersensitivity reaction

Anaphylaxis and infusion related reactions can occur with taxanes.

Read more about premedication for prophylaxis of taxane hypersensitivity reactions
Nausea and vomiting

Read more about prevention of treatment induced nausea and vomiting
Taste and smell alteration

Read more about taste and smell changes

Early (onset days to weeks)
Neutropenia

Abnormally low levels of neutrophils in the blood. This increases the risk of infection. Any fever or suspicion of infection should be investigated immediately and managed aggressively. 

Read more about neutropenia
Thrombocytopenia

A reduction in the normal levels of functional platelets, increasing the risk of abnormal bleeding.  

Read more about thrombocytopenia
Fatigue

Read more about fatigue
Oral mucositis

Erythematous and ulcerative lesions of the gastrointestinal tract (GIT). It commonly develops following chemotherapy, radiotherapy to the head, neck or oesophagus, and high dose chemotherapy followed by a blood and marrow transplant (BMT).

Read more about oral mucositis
Diarrhoea

Read more about treatment induced diarrhoea
Skin rash

Antineoplastic agents can cause a number of changes in the skin with maculo-papular rash the most common type of drug-induced skin reaction. 

Read more about skin rash
Ocular changes

Symptoms may include eye pain, blurred vision, blepharitis, uveitis, optic neuritis, tear duct stenosis, conjunctivitis, hyperlacrimation, watery or dry eyes and photophobia. 
Arthralgia and myalgia

Generalised joint pain or and/or stiffness and muscle aches, often worse upon waking or after long periods of inactivity. Can improve with movement. May be mild or severe, intermittent or constant and accompanied by inflammation. 

Read more about arthralgia and myalgia
Palmar-plantar erythrodysaesthesia (PPE) - hand-foot syndrome (HFS)

Bilateral erythema, tenderness, pain, swelling, tingling, numbness, pruritus, dry rash, or moist desquamation and ulceration of the palms and soles. It is also known as hand-foot syndrome (HFS). Symptoms appear to be dose dependent and palms are affected more than soles.

Read more about hand-foot syndrome associated with chemotherapy
Peripheral neuropathy

Typically symmetrical sensory neuropathy, affecting the fingers and toes, sometimes progressing to the hands and feet.  It is associated with several classes of antineoplastic agents. These include taxanes, platinum-based compounds, vinca alkaloids and some drugs used to treat multiple myeloma.

Read more about peripheral neuropathy
Fluid retention syndrome

Fluid retention, including peripheral oedema and weight gain, may occur with docetaxel treatment. The main risk factor for development is cumulative docetaxel dose. Pre-medication with dexamethasone may be used. Fluid retention will slowly resolve after cessation of treatment.

Read more about fluid retention syndrome associated with docetaxel

Late (onset weeks to months)
Anaemia

Abnormally low levels of red blood cells (RBCs) or haemoglobin in the blood. 

Read more about anaemia
Nail changes

Hyperpigmentation, paronychia, onycholysis, splinter haemorrhage, pyogenic granuloma formation, subungal haematoma and subungal hyperkeratosis are some of the nail changes associated with antineoplastic treatment.   

Read more about nail toxicities
Alopecia - partial

Hair thinning and/or patchy hair loss. Patients can also experience mild to moderate discomfort of the hair follicles, and rarely pain as the hair is falling out.

Read more about alopecia

Delayed (onset months to years)
Menopausal symptoms

Irregular or absent periods, hot flushes, mood swings, sleep disturbance, night sweats, vaginal dryness, decreased libido and dyspareunia. This is caused by ovarian failure and may be temporary or permanent.

Results from the National Surgical Adjuvant Breast and Bowel Project (NSABP) protocol B-18 trial demonstrated an increased likelihood of Breast Conservation Surgery (BCS) in breast cancer patients treated with a neoadjuvant anthracycline-based regimen.r Although the B-18 trial did not demonstrate a survival advantage in patients treated with preoperative chemotherapy, it established pathological complete response (pCR) as a prognostic marker for disease-free survival (DFS).

FEC-D has been successfully utilised in the adjuvant setting with eight-year follow-up data showing a 4% absolute benefit in DFS and 5% benefit in OS (Link to the evidence for adjuvant FEC-D).

A search of the literature did not find strong phase III evidence for use of FEC-D in the neoadjuvant setting. Ohno et alr and von Minckwitz et alr studied the efficacy of neoadjuvant (F)EC-D but in varying combinations with capecitabine.

There were three phase II trials directly studying neoadjuvant FEC-D.rrr The expert reference panel supported publication of the protocol on the basis of the information summarised below. The Japan Breast Cancer Research Group (JBCRG) 01 trial, published in 2008, was the largest study to date evaluating neoadjuvant chemotherapy in this patient populationrr where the Quasi-Pathologic Complete Response (QpCR – no invasive tumour or only focal residual cells) rate was 25%. Within 40 months median follow-up, 3-year DFS was estimated at 98% for patients with QpCR versus those without (89%, HR 0.38 [95% C.I. 0.09 – 0.84]). The overall clinical response rate was 75%. 85% of patients achieved breast conservation. HER-2 status and response to FEC were independent predictors of QpCR. Grade 3/4 neutropaenia was the common adverse event.

In order to achieve a higher pCR with an improved safety profile, the JBCRG-03 trial, published in 2011,r assessed the efficacy of the reverse sequence of the chemotherapy used in the JBCRG-01 trial, with 4 cycles of docetaxel (75 mg/m2 q3w) followed by 4 cycles of 5-fluorouracil 500 mg/m2, epirubicin 100 mg/m2, and cyclophosphamide 500 mg/m2 q3w in patients with early-stage breast cancer. The primary endpoint was the pathological complete response (pCR) rate defined for the breast alone, assessed by a central review committee. Secondary endpoints included clinical response and safety. Of the 132 patients assessable for pathologic response, 23% experienced a pCR and 6% had a near pathological complete response (few remaining cancer cells), resulting in a QpCR of 29%. Clinical response rate following the initial docetaxel regimen was 64%. The overall clinical response rate was 79%. Breast-conserving surgery was performed in 79% of patients. More patients with triple-negative disease experienced a pCR (14/29, 48 %) versus those with other molecular subtypes. The safety profile was acceptable.

Note that all the phase II trials used 4 cycles of FEC and 4 cycles of docetaxel (75 mg/m2). Given that OS and DFS are essentially equivalent whether chemotherapy is given in the adjuvant or neoadjuvant setting, there are arguments for using either the 6 or 8 cycles of FEC-D.

Evidence for the “FEC” portion of the regime is provided by Mouret-Reynier et al,r where pCR rates were 15-25% depending on classifications.

Evidence for the “D” portion of the regime is provided by the NSABP B-27 trial. The addition of sequential docetaxel to AC doubled the pCR rate and increased the clinical complete response (cCR) rate but did not improve disease free survival (DFS) and overall survival (OS) compared to AC alone. (Link to the evidence for Breast neoadjuvant AC followed by docetaxel).

Source Study and year published Supports use Is the dose and regimen consistent with the protocol? Comments
Phase III trials Ohno et al. 2013r Yes No 4 cycles of FEC (5-FU 500 mg/m2, epirubicin 100 mg/m2 and cyclophosphamide 500 mg/m2, day 1 q3w) followed by 4 cycles of docetaxel 75 mg/m2 day 1 q3w +/- capecitabine 1650 mg/m2/day on day 1 to 14
  von Minckwitz. 2010r Yes No 4 cycles of EC (epirubicin 90 mg/m2 and cyclophosphamide 600 mg/m2, day 1 q3w) followed by 4 cycles of docetaxel 100 mg/m2 day 1 q3w alone, in sequence with, or combined with capecitabine 1800 mg/m2/day on day 1 to 14
Phase II trials Toi et al. 2008r Yes No 4 cycles of FEC (5-FU 500 mg/m2, epirubicin 100 mg/m2 and cyclophosphamide 500 mg/m2, day 1 q3w) followed by 4 cycles of docetaxel 75mg/m2 day 1 q3w 
  Iwata et al. 2011r Yes No 4 cycles docetaxel 75 mg/m2 q3w followed by 4 cycles 5-FU 500 mg/m2, epirubicin 100 mg/m2 and cyclophosphamide 500 mg/m2 q3w in patients with early-stage breast cancer
  Focan et al. 2005r Yes No 4 cycles of FEC 100 followed by 4 cycles of docetaxel 
  Yao et al. 2012r Yes No 6 cycles TEC (docetaxel 75 mg/m2, epirubicin 75 mg/m2 and cyclophosphamide 600 mg/m2 + G-CSF), q3w
Observational studies - - -  
Case series - - -  
Guidelines Date published/revised Supports use Is the dose and regimen consistent with the protocol? Comments
NCCN v.1 2014 Yes N/A  
BCCA - - -  
CCO March 2014 Yes Yes 3 cycles of FEC (5-FU 500 mg/m2, epirubicin 100 mg/m2 and cyclophosphamide 500 mg/m2, day 1 q3w) followed by 3 cycles of docetaxel 100 mg/m2 day 1 q3w

Efficacy

A summary of the evidence supporting the effect of this protocol is below.

  Study No. of patients Effect
pCR Iwata et alr 135 23%
Overall clinical response Iwata et alr 135 Response rate (RR) 79% 
(complete RR 21%, partial RR 57%)
BCS* Toi et alr 198 85%
QpCR** Iwata et alr 135 29%

*BCS= Breast conservation surgery
**Quasi-pCR: complete disappearance of invasive carcinoma in the breast or only focal tumour cells remaining in the stroma in the removed breastr

Toxicity

A summary of the toxicities associated with this protocol are included in the table below. The most clinically significant toxicity for both parts of the treatment was myelosuppression. In the JBCRG-01 trial, G-CSF was administered at investigators' discretion in 10.5%, 8.2% and 9.4% of treatment cycles of FEC (part 1), docetaxel (part 2) and both (part 1 and 2) respectively.r For non-hematologic toxicities of any grade, rash, sensory neuropathy, oedema, muscle pain and joint pain occurred more frequently during docetaxel treatment than with FEC. Conversely, the frequency of gastrointestinal symptoms, such as nausea, vomiting and anorexia, was higher with FEC.r

Grade 3/4 toxicity r FEC % (n=198) Docetaxel % (n=194) Importance for prescribing
Neutropenia 44 35 Critical
Febrile neutropenia 20 7 Critical
Leukopenia 35 30 Critical
Thrombocytopenia 1 1 Important
Anaemia 1 0 Important
AST/ALT 2 1 Not important
Nausea 6 1 Not important
Vomiting 5 1 Important
Diarrhoea 1 0 Important
Constipation 0 1 Not important
Fatigue 1 1 Not important
Arthralgia/Myalgia 0 1 Important
Neurotoxicity 0 1 Important
Cardiotoxicity NR NR Critical

FEC = fluorouracil, epirubicin, cyclophosphamide; NR = not reported

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Version 3

Date Summary of changes
09/05/2014 New protocol taken to Medical Oncology Reference Committee meeting.
31/05/2014 Approved and published on eviQ.
22/06/2015 Protocol reviewed electronically by Medical Oncology Reference committee. No changes and next review in 2 years.
31/05/2017 Transferred to new eviQ website. Protocol version number changed to V.2.
03/11/2017 Reviewed by Medical Oncology Reference Committee.
No changes. Review in 5 years.
10/05/2018 Haematological dose modificaitons updated as per consensus of the expert clinician group. Version number increased to V.3.

The information contained in this protocol is based on the highest level of available evidence and consensus of the eviQ reference committee regarding their views of currently accepted approaches to treatment. Any clinician (medical oncologist, haematologist, radiation oncologist, medical physicist, radiation therapist, pharmacist or nurse) seeking to apply or consult this protocol is expected to use independent clinical judgement in the context of individual clinical circumstances to determine any patient's care or treatment. Use is subject to eviQ’s disclaimer available at www.eviQ.org.au

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First approved:
Last reviewed:
Review due:

The currency of this information is guaranteed only up until the date of printing, for any updates please check:

https://www.eviq.org.au/p/1624

22 Apr 2019