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A - Regimen Name

CISPDOCEFU Regimen
CISplatin-DOCEtaxel-Fluorouracil


Disease Site
Head and Neck

Intent
Neoadjuvant

Regimen Category
Evidence-Informed :

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.


Rationale and Uses

Induction Chemotherapy (prior to radiotherapy / chemoradiotherapy) in locally advanced, unresectable head and neck cancer, for patients with ECOG status 0 to 1 and no prior chemotherapy or radiotherapy.

 
B - Drug Regimen

DOCEtaxel

(Round to nearest 1 mg)
75 mg /m² IV Day 1
CISplatin

(Round to nearest 1 mg)
100 mg /m² IV Day 1
fluorouracil

(Round to nearest 50 mg)
1000 mg /m²/day IV over 24 hours as continuous infusion Days 1 to 4

Alternative schedule:

DOCEtaxel

(Round to nearest 1 mg)
75 mg /m² IV Day 1
CISplatin

(Round to nearest 1 mg)
75 mg /m² IV Day 1
fluorouracil

(Round to nearest 50 mg)
750 mg /m² IV over 24 hours as continuous infusion Days 1 to 5
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C - Cycle Frequency

REPEAT EVERY 21 DAYS

For a usual total of 4 cycles unless disease progression or unacceptable toxicity occurs

 
D - Premedication and Supportive Measures

Antiemetic Regimen:

High (with cisplatin day 1)
Minimal (fluorouracil ONLY days)


Febrile Neutropenia Risk:

High

Consider G-CSF prophylaxis for patients at high risk of febrile neutropenia. See G-CSF recommendations.


Other Supportive Care:

  • Dexamethasone 8 mg bid po for 3 days starting 1 day prior to docetaxel (prevent anaphylaxis/ fluid retention.)
  • In clinical trials, all patients received prophylactic antibiotics from days 5 to 15.
  • Use standard regimens for cisplatin pre-medication and hydration. See Cisplatin monograph.

Also refer to CCO Antiemetic Summary

 
E - Dose Modifications

Doses should be modified according to the protocol by which the patient is being treated. The following recommendations have been adapted from clinical trials or product monographs and could be considered.

Dosage with toxicity

 

Toxicity Type/ Counts x 109/L
 
Toxicity Type/ Counts x 109/L
Docetaxel* (% previous dose)
Cisplatin* (% previous dose)
Fluorouracil* (% previous dose)
Febrile neutropenia
Or
Grade 4 neutropenia / thrombocytopenia
 
Hold, then 75% *
Hold, then 75% *
Hold, then 75%*
Grade 2 neurotoxicity or ototoxicity
 
 
No change; monitor
Consider dose reduction
No change
Grade 3 neurotoxicity or ototoxicity
 
 
Discontinue
Discontinue
Discontinue
Grade 3 mucositis or diarrhea
 
 
No change
No change
66%*
Grade 2 or 3 hand-foot syndrome
 
 
No change
No change
66%*
Grade 3 skin reactions
 
 
75%*; discontinue if recurs
No change
66%*
Any occurrence of cystoid macular edema     Hold and investigate; refer patient promptly to an ophthalmic examination. Discontinue if confirmed. No change No change
Other Grade 3 non-hematologic / organ#
 
 
 
 
 
Hold*, then 75%
Hold*, then 75%
Hold*, then 75%
Grade 4 non-hematologic / organ
 
 
Discontinue
Discontinue
Discontinue

*Major organ toxicity should have recovered  to ≤ grade 1, ANC ≥ 1.5 x 109/L and platelets ≥ 100 x 109/L prior to retreatment. Modify the agent to which the toxicity is considered related.
# Except for alopecia, fatigue, nail changes



Hepatic Impairment

 
AST and/ or ALT
 
Alk Phosp
 
Bilirubin
Cisplatin
Docetaxel (% previous dose)
Fluorouracil (% previous dose)
Mild-moderate
> 1.5 X ULN
AND
> 2.5 x ULN
 
 
No change
Do not treat
 
Severe
> 3.5 x ULN
OR
> 6 x ULN
OR
> ULN
Do not treat. Discontinue if treatment already started.
 
 
 
 
 
 
 
> 4 ULN
Discontinue

Renal Impairment

Creatinine clearance

Cisplatin (% previous dose)

Fluorouracil (% previous dose)

Docetaxel
46-60
75%

No change

No change

30-45
50%

No change

No change

<30
Discontinue

Consider ↓

No change


Dosage in the Elderly

No adjustment required, but caution should be exercised in elderly patients with poor performance status who are receiving docetaxel.

Geriatric patients may be at higher risk of developing nephrotoxicity, ototoxicity/neurotoxicity or hematologic adverse effects with cisplatin.
 

 


 
F - Adverse Effects

Refer to DOCEtaxel, CISplatin, fluorouracil drug monograph(s) for additional details of adverse effects


Prolonged 5FU regimens have more Hand-Foot Syndrome but less myelosuppression and GI effects compared to bolus infusions.

Most Common Side Effects 

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

  • Myelosuppression ± infections, bleeding (may be severe)
  • Hypersensitivity reactions (may be severe)
  • Fluid retention (may be severe)
  • Neuropathy, ototoxicity (may be severe)
  • Cutaneous effects
  • Alopecia
  • GI (nausea, stomatitis, diarrhea)
  • Rash (may be severe)
  • Musculoskeletal pain (may be severe)
  • Nephrotoxicity
  • Fatigue
  • Hand-foot syndrome
  • Lacrimation/ lacrimal duct obstruction
  • Secondary malignancies
  • Pneumonitis
  • Arterial thromboembolism
  • Venous thromboembolism
  • GI obstruction / perforation
  • DIC
  • Arrhythmia, heart failure
  • Thrombotic microangiopathy, hemolytic uremic syndrome
  • Raynaud's syndrome
  • Cystoid macular edema
 
G - Interactions

Refer to DOCEtaxel, CISplatin, fluorouracil drug monograph(s) for additional details

 
H - Drug Administration and Special Precautions

Refer to DOCEtaxel, CISplatin, fluorouracil drug monograph(s) for additional details

 

 
I - Recommended Clinical Monitoring

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 renal function tests (including electrolytes and magnesium) and urinalysis
  • Baseline and regular liver functions tests
  • Clinical toxicity assessment (including neurologic, GI, ototoxicity, hypersensitivity, lethargy, fluid retention, cutaneous effects, infection, bleeding, musculoskeletal pain, thromboembolism, ophthalmic, respiratory); at each visit
  • Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version


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J - Administrative Information

Approximate Patient Visit
Day 1: 5-6 hours; 5FU only days: 0.5 hour
Pharmacy Workload (average time per visit)
37.412 minutes
Nursing Workload (average time per visit)
92.083 minutes
 
K - References

Cisplatin, docetaxel, fluorouracil drug monographs, Cancer Care Ontario.

Posner MR, Hershock DM, Blajman CR, et al. Cisplatin and Fluorouracil Alone or with Docetaxel in Head and Neck Cancer. N Engl J Med 2007; 357: 1705-15.

Vermorken JB, Remenar E, Van Herpen C et al. Cisplatin, Fluorouracil, and Docetaxel in Unresectable Head and Neck Cancer. N Engl J Med 2007; 357: 1695-704.


October 2017 Added PEBC guideline link


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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.
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.