You are using an outdated browser. We suggest you update your browser for a better experience. Click here for update.
Close this notification.
Skip to main content Skip to search

COVID-19: Obtenez les dernières mises à jour ou faites une autoévaluation.

Effectuez un dépistage du virus de l'hépatite B chez tous les patients cancéreux débutant un traitement systémique. Apprenez-en davantage sur le dépistage et la gestion du virus de l'hépatite B.

Certaines de ces informations ou toutes, dans certains cas, n’apparaissent qu’en Anglais. Vous pouvez demander la version française

Les renseignements du Formulaire de médicaments s’adressent aux professionnels de la santé. Il ne s’agit pas d’un avis médical. Certains des renseignements, y compris ceux sur le financement des médicaments anticancéreux, ne s’appliquent pas à tous les patients. Les plans de traitement du cancer sont propres à chaque patient. Si vous êtes un patient, veuillez parler avec votre équipe soignante pour comprendre comment ces renseignements s’appliquent à vous.

A - Regimen Name

CISPFU(RT) Regimen
CISplatin-Fluorouracil


Disease Site
Gastrointestinal - Esophagus
Gastrointestinal - Gastric / Stomach

Intent
Adjuvant
Palliative

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.

 
B - Drug Regimen

Weeks 1 and 5 concurrent with radiation:

CISplatin
75 mg /m² IV Day 1
fluorouracil
1000 mg /m²/day IV over 24 hours as continuous infusion Days 1 to 4

(Maximum 2000 mg/day)

Alternative Cisplatin Schedule:

CISplatin
25 mg /m² IV Days 1 to 3 OR Days 2 to 4

 

OR

CISplatin
15 mg /m² IV Days 1 to 5
back to top
 
C - Cycle Frequency

Concurrent with radiation on Weeks 1 and 5

THEN post-radiation q 21 days for 4 cycles total

 
D - Premedication and Supportive Measures

Antiemetic Regimen:

High (≥ 70mg/m²)
Moderate (< 70mg/m² )


Febrile Neutropenia Risk:

Moderate

Other Supportive Care:

Also refer to CCO Antiemetic Summary

 
E - Dose Modifications

Doses should be modified according to the protocol by which the patient is being treated.

Dosage with toxicity

Hematologic Toxicities

See appendix 6 for general recommendations.

GI Toxicities

 

Toxicity Action
If Mucositis or Diarrhea ≥ Grade 3 in previous course REDUCE to 2/3 dose of 5-FU
If Hand-Foot Syndrome ≥ Grade 2 REDUCE to 2/3 dose of 5-FU

 



Hepatic Impairment

If Bilirubin > 4 x ULN, OMIT 5FU dose.


Renal Impairment

Toxicity Action

If renal function has not returned to normal
(CrCl < 1 mL/sec or Serum Creatinine > 136 µmol/L) by Day 1 of cycle

OMIT Cisplatin
(Recommended action)

 
F - Adverse Effects

Refer to fluorouracil, CISplatin 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

  • Nausea, vomiting
  • Nephrotoxicity (may be severe)
  • Hearing impairment
  • Myelosuppression +/- infection, bleeding
  • Abnormal electrolyte(s)
  • Anorexia
  • Diarrhea
  • Mucositis
  • Neurotoxicity
  • Photosensitivity
  • Rash
  • Increased LFTs
  • Arterial thromboembolism
  • Venous thromboembolism
  • Cardiotoxicity
  • Hemolysis
  • Hypersensitivity
  • Radiation recall reaction
  • Seizure
  • Vasculitis
 
G - Interactions

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


Fluorouracil is a known radiation sensitizer. Patient should be carefully monitored for gastrointestinal toxicity when they are receiving concurrent 5FU Radiation therapy.

 
H - Drug Administration and Special Precautions

Refer to fluorouracil, CISplatin 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. Interim counts should be done in first cycle and repeated if dose modifications necessary.
  • Baseline and regular liver and renal function tests (including electrolytes and magnesium).
  • Clinical toxicity assessment (including stomatitis, neurotoxicity, ototoxicity); at each visit
  • Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version


back to top
 
J - Administrative Information

Approximate Patient Visit
Day 1-4: 3 to 4 hours
Pharmacy Workload (average time per visit)
19.124 minutes
Nursing Workload (average time per visit)
52.917 minutes
 
K - References

Cisplatin and fluorouracil drug monographs, Cancer Care Ontario.

Bedenne L, Michel P, Bouché O, et al.  Chemoradiation followed by surgery compared with chemoradiation alone in squamous cancer of the esophagus: FFCD 9102.  J Clin Oncol 2007 Apr 1;25(10):1160-8.

Conroy T, Galais MP, Raoul JL, et al.  Definitive chemoradiotherapy with FOLFOX versus fluorouracil and cisplatin in patients with oesophageal cancer (PRODIGE5/ACCORD17): final results of a randomised, phase 2/3 trial.  Lancet Oncol.2014 Mar;15(3):305-14. 

Herskovic A, Martz K, Muhyi A et al. Combined chemotherapy and radiotherapy compared with radiotherapy alone in patients with cancer of the esophagus. N Engl J Med 1992. 326:1593-8.

Minsky BD, Pajak TF, Ginsberg RJ, et al.  INT 0123 (Radiation Therapy Oncology Group 94-05) phase III trial of combined-modality therapy for esophageal cancer: high-dose versus standard-dose radiation therapy.  J Clin Oncol 2002 Mar 1;20(5):1167-74.

Tepper J, Krasna MJ, Niedzwiecki D, et al. Phase III trial of trimodality therapy with cisplatin, fluorouracil, radiotherapy, and surgery compared with surgery alone for esophageal cancer: CALGB 9781. J Clin Oncol. 2008 Mar 1;26(7):1086-92.


October 2017 aligned intent, dosing and cycle frequency info with QBP


back to top
 
L - Other Notes

Schedule pump teaching session BEFORE first day of infusion.

 
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.