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.
CETU(RT)
(Squamous cell)
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.
For the initial treatment of locally or regionally advanced squamous cell head and neck cancer without distant metastases, for patients who are unable to use cisplatin or carboplatin/5-FU due to a medical contraindication, and are receiving cetuximab concurrently with curative radical radiotherapy. Use with caution in patients with known cardiac disease.
cetuximab
New Drug Funding Program
(Cetuximab and Radiation - Locally Advanced Squamous Cell Carcinoma of the Head and Neck)
(NDFP Website)
REPEAT EVERY 7 DAYS
Continue for duration of radiotherapy (6-7 weeks) unless unacceptable toxicities
Minimal
Low
Screen for hepatitis B virus in all cancer patients starting systemic treatment. Refer to the hepatitis B virus screening and management guideline.
Premedications (prophylaxis for infusion reaction):
- H1-receptor antagonist (e.g. diphenhydramine 50 mg IV) 30-60 minutes prior to the dose.
- Corticosteroid IV 30-60 minutes prior to the dose.
- Consider discontinuing pre-medications after the 2nd infusion based on clinical judgment and the presence/severity of IR.
Other Supportive Care:
- Patients should use sun protection while receiving cetuximab and for 2 months after treatment completion.
- Consider pre-emptive therapy for EGFR inhibitor-related skin toxicity; the following was shown to be of benefit with panitumumab treatment, starting the day before treatment and continued until week 6. (Lacouture et al, 2010):
- Skin moisturizer applied to the face, hands, feet, neck, back and chest in the morning
- Sunscreen to exposed areas (SPF > 15, UVA and UVB) before going outdoors
- Hydrocortisone 1% cream to the face, hands, feet, neck, back and chest at bedtime
- Doxycycline (or minocycline) PO
- Refer to the Canadian recommendations for the management of skin rash during EGFR-targeted monoclonal antibody treatment for GI malignancies. (Melosky et al, 2009)
- Also refer to CCO Antiemetic Recommendations.
Doses should be modified according to the protocol by which the patient is being treated.
Dosage with toxicity
Dose Level | Cetuximab Dose (mg/m² weekly) |
0 | 250 |
-1 | 200 |
-2 | 150 |
-3 | Discontinue |
Toxicity |
Action |
Next cycle |
Pneumonitis |
Hold and investigate |
Discontinue if confirmed. |
Keratitis |
Hold and refer to ophthalmologist |
Consider discontinuation. |
Dosage modification for skin toxicity:
Grade 3 or 4 Rash |
Action |
Outcome |
Cetuximab Dose |
1st occurrence |
Delay infusion |
Improvement |
Resume at same dose |
No improvement |
Discontinue |
||
2nd occurrence |
Delay infusion |
Improvement |
Resume at 1 dose level ↓ |
No improvement |
Discontinue |
||
3rd occurrence |
Delay infusion |
Improvement | Resume at 1 dose level ↓ |
No improvement | Discontinue | ||
4th occurrence |
Discontinue |
Management of Infusion-related reactions:
Also refer to the CCO guideline for detailed description of Management of Cancer Medication-Related Infusion Reactions.
Grade | Management | Re-challenge |
1 or 2 |
Restart: |
|
3 or 4 |
|
|
Hepatic Impairment
Population pharmacokinetics suggest no significant impact.
Renal Impairment
Population pharmacokinetics suggest no significant impact.
Dosage in the Elderly
Insufficient patients have been enrolled in head and neck studies to draw firm conclusions.
Refer to cetuximab drug monograph(s) for additional details of adverse effects.
The following table is mostly based on incidences from metastatic colorectal cancer studies.
Very common (≥ 50%) |
Common (25-49%) |
Less common (10-24%) |
Uncommon (< 10%), but may be severe or life-threatening |
|
|
|
|
Refer to cetuximab drug monograph(s) for additional details.
- Concurrent radiation may increase the risk of mucocutaneous toxicity.
Refer to cetuximab drug monograph(s) for additional details.
Administration:
- Do not shake or further dilute the solution.
- DO NOT administer as an IV push or bolus.
- Transfer undiluted solution into a compatible empty infusion container.
- Cetuximab is compatible with:
- glass,
- polyolefin, polyethylene, ethylene vinyl acetate (EVA), DEHP plasticized PVC, or PVC bags,
- polyethylene, EVA, PVC, polybutadiene or polymethane infusion sets, and
- polyethersulfone, polyamide or polysulfone in-line filters.
- If given with radiation (for head and neck cancer), give cetuximab 1 week prior to radiation start date. For maintenance, complete cetuximab infusion 1 hour prior to that day's radiation.
- Administer the undiluted solution via a low protein binding 0.22-micrometer in-line filter, piggybacking to the patient’s infusion line.
- Infuse initial loading dose over 2 hours, and maintenance dose over 1 hour (maximum rate 10 mg/min). (May require infusion at slower rate in those who experienced infusion reactions).
- Prime administration line with drug solution before infusion. May use NS to flush line at the end of infusion.
- A 1-hour observation period is recommended following each cetuximab infusion. Longer observation periods may be required in those who experienced infusion reactions.
- Should not be mixed or diluted with other drugs.
- Store unopened vials at 2-8°C.
Also refer to the CCO guideline for detailed description of Management of Cancer Medication-Related Infusion Reactions.
Contraindications:
- Patients with known hypersensitivity to this drug or any of its components
Other Warnings/Precautions:
- Patients with a history of, or pre-existing keratitis, dry eyes or contact lens use
- Patients with poor performance status, or cardiopulmonary disease are at increased risk of severe hypersensitivity
- Cetuximab plus radiation therapy for head and neck cancer should be used with caution in patients who are over age 65, have poor performance status, known history of coronary artery disease, arrhythmias, congestive heart failure or receiving cardiotoxic agents as fatal events have been reported.
Pregnancy/Lactation:
- This regimen is not recommended for use in pregnancy. Adequate contraception should be used by patients and their partners while on treatment and after the last treatment dose. Recommended methods and duration of contraception may differ depending on the treatment. Refer to the drug monograph(s) for more information.
- Breastfeeding is not recommended during treatment and after the last treatment dose. Refer to the drug monograph(s) for recommendations after the last treatment dose (if available).
- Fertility effects: Unknown
Treating physicians may decide to monitor more or less frequently for individual patients but should always consider recommendations from the product monograph.
Refer to the hepatitis B virus screening and management guideline for monitoring during and after treatment.
Recommended Clinical Monitoring
-
Electrolytes, including serum magnesium, potassium and calcium; Baseline, weekly, and monthly for 2 months following completion of therapy
-
CBC; Baseline and as clinically indicated
-
Renal function; Baseline and as clinically indicated
-
Clinical toxicity assessment for infusion reactions, skin, nail, cardiac, thromboembolism, GI, hypersensitivity, respiratory symptoms, fatigue and keratitis; at each visit
-
Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version
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Bonner JA, Harari PM, Giralt J, Cohen RB, Jones CU, Sur RK, et al. Radiotherapy plus cetuximab for locoregionally advanced head and neck cancer: 5-year survival data from a phase 3 randomized trial, and relation between cetuximab-induced rash and survival. Lancet Oncol 2010;11(1):21-8.
Lacouture, ME, Mitchell EP, Piperdi B et al. Skin toxicity evaluation protocol with panitumumab (STEPP), a phase II, open-label, randomized trial evaluating the impact of a pre-emptive skin treatment regimen on skin toxicities and quality of life in patients with metastatic colorectal cancer. J Clin Oncol 2010; 28: 1351-7.
Melosky B, Burkes R, Rayson D, et al. Management of skin rash during EGFR-targeted monoclonal antibody treatment for gastrointestinal malignancies: Canadian recommendations. Current Oncology 2009; 16(10): 14-24.
July 2023 Updated Other Supportive Care, Dose Modifications, Interactions, Drug administration and Special Precautions, and Monitoring sections
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.
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