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Cetuximab monotherapy for metastatic, RAS/BRAF wildtype colorectal cancer[1,2]

Cetuximab monotherapy for metastatic, RAS/BRAF wildtype colorectal cancer[1,2]
Cycle length: Weekly OR every 2 weeks.*
Drug Dose and route Administration Given on days
Cetuximab (loading dose)[1] 400 mg/m2 IV The appropriate dose should be withdrawn from the vials (supplied in a concentration of 2 mg/mL) and aseptically transferred into an empty sterile IV bag without further dilution. The initial dose should be infused over 120 minutes.¶Δ Day 1
Cetuximab (subsequent doses) 250 mg/m2 IV If the day 1 loading dose is tolerated, subsequent doses may be administered over 60 minutes. Weekly, beginning day 8
OR
Cetuximab (loading dose and subsequent doses)*[2] 500 mg/m2 IV The appropriate dose should be withdrawn from the vials (supplied in a concentration of 2 mg/mL) and aseptically transferred into an empty sterile IV bag without further dilution.¶Δ When administered every 2 weeks, all doses should be infused over 120 minutes. Every 2 weeks
Pretreatment considerations:
Emesis risk
  • LOW (<30% frequency of emesis).
  • Refer to UpToDate topic on "Prevention and treatment of chemotherapy-induced nausea and vomiting in adults".
Prophylaxis for infusion reactions
  • Premedication with diphenhydramine with or without a glucocorticoid at least prior to the first infusion.[2]
  • In areas with a high frequency of infusion reactions (eg, middle-southeastern United States), testing for IgE antibodies to galactose-alpha-1,3 galactose should be considered.
  • Refer to UpToDate topic on "Infusion-related reactions to therapeutic monoclonal antibodies used for cancer therapy".
Monitoring parameters:
  • Assess basic metabolic panel (including creatinine, magnesium, calcium, and potassium) prior to each dose.
  • Monitor serum calcium, magnesium, and potassium levels weekly for eight weeks after completion of therapy.[2]
  • Monitor for skin rash.
Suggested dose modifications for toxicity:
Dematologic toxicity
  • Severe dermatologic reactions, such as acneiform rash, require delayed administration of cetuximab and/or dose reduction.
  • Refer to UpToDate topic on "Acneiform eruption secondary to epidermal growth factor receptor (EGFR) and MEK inhibitors".
If there is a change in body weight of at least 10%, doses should be recalculated.
This table is provided as an example of how to administer this regimen; there may be other acceptable methods. This regimen must be administered by a clinician trained in the use of chemotherapy, who should use independent medical judgment in the context of individual circumstances to make adjustments, as necessary.
IV: intravenous; IgE: immunoglobulin E; FDA: US Food and Drug Administration.
* Results from a nonrandomized phase II trial[3] and a multicenter retrospective analysis[4] suggest that cetuximab at a dose of 500 mg/m2 initially followed by 500 mg/m2 every two weeks results in similar plasma concentrations and single-agent activity as does weekly dosing. This alternative dosing regimen is approved by the FDA.[2]
¶ Cetuximab should be administered with an infusion or syringe pump, using a low protein-binding 0.22 micron in line filter. Do not shake or dilute. Flush line with normal saline.
Δ A slower infusion rate should be considered in areas with a high incidence of infusion reactions (such as the southeast United States). Refer to UpToDate topic on "Infusion reactions to the therapeutic monoclonal antibodies used in cancer therapy".
References:
  1. Jonker DJ, et al. N Engl J Med 2007; 357:2040.
  2. Cetuximab injection. United States Prescribing Information. US National Library of Medicine. (Available online at accessdata.fda.gov/drugsatfda_docs/label/2021/125084s277s280lbl.pdf, accessed on April 8, 2021).
  3. Pfeiffer P, et al. Ann Oncol 2008; 19:1141.
  4. Bouchahda M, et al. Med Oncol 2011; 28S:S253.
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