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A - Regimen Name

CAPECISP+CETU Regimen
Capecitabine-Cisplatin-Cetuximab


Disease Site
Head and Neck

Intent
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.

This 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). 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.


Supplementary Public Funding

capecitabine
ODB - General Benefit (capecitabine)

 
B - Drug Regimen

Cycle 1:

cetuximab
400 mg /m² IV Day 1 ONLY
cetuximab
250 mg /m² IV Days 8, 15
(This drug is not currently publicly funded for this regimen and intent)
CISplatin
100 mg /m² IV Day 1
capecitabine
1000 mg /m² PO BID; Days 1 to 14

(Total dose 2000 mg/m2/day)
(Available as 150 mg or 500 mg tablets)

Cycles 2 to 6: 

cetuximab
250 mg /m² IV Days 1, 8, 15
(This drug is not currently publicly funded for this regimen and intent)
CISplatin
100 mg /m² IV Day 1
capecitabine
1000 mg /m² PO BID; Days 1 to 14

(Total dose 2000 mg/m2/day)
(Available as 150 mg or 500 mg tablets)

Note: Report as regimen code CETU when used as maintenance after chemotherapy portion is complete

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C - Cycle Frequency

REPEAT EVERY 21 DAYS

For a maximum of 6 cycles of CAPECISP+CETU until disease progression or unacceptable toxicity

After 6 cycles, patients with at least stable disease may continue to receive weekly maintenance cetuximab until disease progression or unacceptable toxicity.

 
D - Premedication and Supportive Measures

Antiemetic Regimen:

High (D1)
Minimal (D8, 15)
No routine prophylaxis for capecitabine

Other Supportive Care:

Standard regimens for Cisplatin premedication and hydration should be followed. Refer to local guidelines.

Also refer to CCO Antiemetic Summary
 
J - Administrative Information

Approximate Patient Visit
Cisplatin and Cetuximab: 4 hours; Cetuximab only: 2 hours
Pharmacy Workload (average time per visit)
36.087 minutes
Nursing Workload (average time per visit)
41.667 minutes
 
K - References

Hitt R, Jimeno A, Rodríguez-Pinilla M, et al.  Phase II trial of cisplatin and capecitabine in patients with squamous cell carcinoma of the head and neck, and correlative study of angiogenic factors.  Br J Cancer. 2004 Dec 13; 91(12): 2005–2011.

Vermorken JB, Mesia R, Rivera F, et al. Platinum-based chemotherapy plus cetuximab in head and neck cancer. N Engl J Med. 2008 Sep 11;359(11):1116-27.

Yoshino T, Hasegawa Y, Takahashi S, et al. Platinum-based chemotherapy plus cetuximab for the first-line treatment of Japanese patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck: results of a phase II trial. Jpn J Clin Oncol. 2013 May;43(5):524-31.

August 2019 removed archived PEBC guideline links


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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.