Cetuximab

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

  1. colorectal cancer
  2. head and neck cancer
  3. 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

  1. acne vulgaris
  2. acneiform rash
  3. alopecia
  4. anaphylactic shock
  5. anaphylactoid reactions
  6. angina
  7. angioedema
  8. anorexia
  9. anorexia
  10. antibody formation
  11. anxiety
  12. arthralgia
  13. aseptic meningitis
  14. asthenia
  15. blepharitis
  16. bone pain
  17. bronchospasm
  18. cardiac arrest
  19. cheilitis
  20. chills
  21. confusion
  22. conjunctivitis
  23. constipation
  24. cough
  25. dehydration
  26. depression
  27. diaphoresis
  28. diarrhea
  29. Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
  30. dysgeusia
  31. dyspepsia
  32. dyspnea
  33. elevated hepatic enzymes
  34. erythema
  35. exfoliative dermatitis
  36. fatigue
  37. fever
  38. flushing
  39. folliculitis
  40. headache
  41. heart failure
  42. hoarseness
  43. hypertension
  44. hypertensive crisis
  45. hypertrichosis
  46. hypocalcemia
  47. hypokalemia
  48. hypomagnesemia
  49. hypotension
  50. infection
  51. infusion-related reactions
  52. insomnia
  53. keratitis
  54. leukopenia
  55. maculopapular rash
  56. malaise
  57. myocardial infarction
  58. nausea
  59. neutropenia
  60. palmar-plantar erythrodysesthesia (hand and foot syndrome)
  61. peripheral neuropathy
  62. pharyngitis
  63. pneumonitis
  64. pruritus
  65. pulmonary embolism
  66. rash
  67. renal failure (unspecified)
  68. respiratory arrest
  69. seizures
  70. serious hypersensitivity reactions or anaphylaxis
  71. sinus tachycardia
  72. skin erosion
  73. skin hyperpigmentation
  74. Stevens-Johnson syndrome
  75. stomatitis
  76. syncope
  77. telangiectasia
  78. toxic epidermal necrolysis
  79. tremor
  80. urticaria
  81. vesicular rash
  82. visual impairment
  83. vomiting
  84. weight loss
  85. xerosis
  86. 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
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