Cetuximab Brand Name– Erbitux
What is Cetuximab
Cetuximab is a recombinant, human/mouse chimeric monoclonal antibody that binds specifically to the extracellular domain of the human epidermal growth factor receptor (EGFR), mediating antibody-dependent cellular cytotoxicity (ADCC) against certain human tumor types.
In vitro assays and in vivo animal studies have shown that cetuximab inhibits the growth and survival of tumor cells that express EGFR; no anti-tumor effects were observed in human tumor xenografts lacking EGFR expression.
It is indicated for the treatment of advanced squamous cell carcinoma of the head and neck (SCCHN) as monotherapy, in combination with radiation, or in combination with chemotherapy.
It is also FDA approved for the treatment of K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer (mCRC). Confirmation of EGFR and Ras status is required prior to treatment for colorectal cancer; because EGFR expression has been detected in nearly all SCCHN tumor specimens, patients are not required to have immunohistochemical evidence of EGFR tumor expression prior to treatment.
Treatment with cetuximab can result in severe infusion-related reactions as well as cardiopulmonary arrest and sudden death.
Closely monitor serum electrolytes, including serum magnesium, potassium, and calcium, during and after treatment with cetuximab.
Mucocutaneous adverse reactions and dermatologic toxicities are also common; patients should be instructed to limit sun exposure.
Indications
- colorectal cancer
- head and neck cancer
- non-small cell lung cancer (NSCLC)
For the treatment of KRAS wild-type metastatic colorectal cancer
NOTE: Cetuximab is not indicated for the treatment of RAS mutant colorectal cancer or when the results of RAS mutation tests are unknown. The absence of a RAS mutation should be confirmed by an FDA approved test prior to starting therapy.
NOTE: The serine-threonine kinase BRAF is the principal effector of KRAS. The introduction of the mutant BRAF V600E allele may impair therapeutic response to EGFR inhibitors. Mutant BRAF may be present in wild-type KRAS.
for the first-line treatment of KRAS wild-type, EGFR-expressing, metastatic colorectal cancer (mCRC) in combination with FOLFIRI (irinotecan, 5-fluorouracil, leucovorin)
NOTE: In clinical trials, response rates did not correlate with either the percentage of EGFR positive cells or the intensity of EGFR expression. EGFR expression status and the absence of a Ras mutation should be determined by an FDA approved test prior to starting therapy (http://www.fda.gov/medicaldevices/productsandmedicalprocedures/invitrodiagnostics/ucm301431.htm)
Side Effects
- acne vulgaris
- acneiform rash
- alopecia
- anaphylactic shock
- anaphylactoid reactions
- angina
- angioedema
- anorexia
- anorexia
- antibody formation
- anxiety
- arthralgia
- aseptic meningitis
- asthenia
- blepharitis
- bone pain
- bronchospasm
- cardiac arrest
- cheilitis
- chills
- confusion
- conjunctivitis
- constipation
- cough
- dehydration
- depression
- diaphoresis
- diarrhea
- Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
- dysgeusia
- dyspepsia
- dyspnea
- elevated hepatic enzymes
- erythema
- exfoliative dermatitis
- fatigue
- fever
- flushing
- folliculitis
- headache
- heart failure
- hoarseness
- hypertension
- hypertensive crisis
- hypertrichosis
- hypocalcemia
- hypokalemia
- hypomagnesemia
- hypotension
- infection
- infusion-related reactions
- insomnia
- keratitis
- leukopenia
- maculopapular rash
- malaise
- myocardial infarction
- nausea
- neutropenia
- palmar-plantar erythrodysesthesia (hand and foot syndrome)
- peripheral neuropathy
- pharyngitis
- pneumonitis
- pruritus
- pulmonary embolism
- rash
- renal failure (unspecified)
- respiratory arrest
- seizures
- serious hypersensitivity reactions or anaphylaxis
- sinus tachycardia
- skin erosion
- skin hyperpigmentation
- Stevens-Johnson syndrome
- stomatitis
- syncope
- telangiectasia
- toxic epidermal necrolysis
- tremor
- urticaria
- vesicular rash
- visual impairment
- vomiting
- weight loss
- xerosis
- xerostomia
Monitoring Parameters
- pregnancy testing
- serum calcium
- serum magnesium
- serum potassium
Contraindications
- breast-feeding
- cardiac arrest
- cardiac arrhythmias
- cardiac disease
- contraception requirements
- coronary artery disease
- electrolyte imbalance
- heart failure
- history of tick bites
- hypocalcemia
- hypokalemia
- hypomagnesemia
- infection
- infertility
- infusion-related reactions
- KRAS mutations
- murine protein hypersensitivity
- pneumonitis
- pregnancy
- pregnancy testing
- pulmonary disease
- radiation therapy
- red meat hypersensitivity
- reproductive risk
- respiratory arrest
- sunlight (UV) exposure
Interactions
- Cisplatin
- Echinacea
- Palifermin
- Penicillamine
- Tuberculin Purified Protein Derivative, PPD
