Cetuximab

(Erbitux®)

Erbitux®

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Drug updated on 4/17/2024

Dosage FormInjection (intravenous; 100 mg/50 mL [2 mg/mL] or 200 mg/100 mL [2 mg/mL])
Drug ClassEpidermal growth factor receptor antagonists
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of locally or regionally advanced squamous cell carcinoma of the head and neck in combination with radiation therapy.
  • Indicated for the treatment of recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck in combination with platinum-based therapy with fluorouracil.
  • Indicated for the treatment of recurrent or metastatic squamous cell carcinoma of the head and neck progressing after platinum-based therapy
  • Indicated for the treatment of K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer as determined by an FDA-approved test: in combination with FOLFIRI for first-line treatment, in combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy, as a single-agent in patients who have failed oxaliplatin- and irinotecan-based chemotherapy or who are intolerant to irinotecan.
  • Indicated for the treatment of BRAF V600E mutation-positive metastatic colorectal cancer (CRC): in combination with encorafenib, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy.

Summary
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  • Cetuximab (Erbitux) is indicated for the treatment of various conditions including locally or regionally advanced squamous cell carcinoma of the head and neck, recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck, K-Ras wild-type EGFR-expressing metastatic colorectal cancer, and BRAF V600E mutation-positive metastatic colorectal cancer.
  • Nine systematic reviews/meta-analyses were reviewed to compare cetuximab with other therapeutic agents in terms of safety and effectiveness. The studies also highlighted subgroup considerations.
  • In comparison with panitumumab for treating metastatic colorectal cancer, both drugs showed no significant difference in overall survival rate, progression-free survival rate, and response rate, indicating comparable effectiveness. However, their adverse events profiles varied slightly; cetuximab had lower incidents of paronychia but higher incidents of hypomagnesemia.
  • When combined with the FOLFOXIRI chemotherapy regimen for metastatic colorectal cancer treatment, cetuximab improved ORR (objective response rate) and R0 resection rates, demonstrating a potent combination especially for initially unresectable cases. However, this combination raised concerns over grade 3 and 4 adverse events like diarrhea and neutropenia.
  • For head and neck squamous cell carcinoma, concurrent use of cetuximab with radiotherapy was found less effective than concurrent platinum-based chemotherapy with radiotherapy in terms of overall survival rate among other factors. Subgroup analysis notably in HPV-positive patients mirrored these results, where efficacy was significantly inferior compared to non-cetuximab therapies.
  • The safety profile across studies revealed that first-line bevacizumab-based chemotherapy showed a lower risk of dermatological and renal adverse events but a higher risk of cardiovascular issues compared to regimens based on Erbitux (cetuximab).

Product Monograph / Prescribing Information

Document TitleYearSource
Erbitux (cetuximab) Prescribing Information.2021Eli Lilly and Company., Indianapolis, IN

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Triplet-drug chemotherapy combined with anti-EGFR antibody as an effective therapy for patients with initially unresectable metastatic colorectal cancer: a meta-analysis.2023World journal of Surgical Oncology
Tolerability on serious adverse events of first-line bevacizumab and cetuximab for Ras wild-type metastatic colorectal cancer: a systematic review and meta-analysis.2022Healthcare
A comparison of panitumumab and cetuximab in the treatment of KRAS wild-type metastatic colorectal cancer: a systematic review and meta-analysis.2022Immunopharmacology and Immunotoxicology
Efficacy and safety of Cetuximab dosing (biweekly vs weekly) in patients with KRAS wild-type metastatic colorectal cancer: a meta-analysis.2022The Oncologist
Efficacy and safety of triplet chemotherapy plus anti-EGFR agents in metastatic colorectal cancer: a systematic review and meta-analysis. 2022World Journal of Surgical Oncology
Safety assessment on serious adverse events of targeted therapeutic agents prescribed for RAS wild-type metastatic colorectal cancer: Systematic review and network meta-analysis.2022International Journal of Environmental Research and Public Health
First-line treatment of advanced epidermal growth factor receptor (EGFR) mutation positive non-squamous non-small cell lung cancer.2021The Cochrane Database of Systematic Reviews
Comparison between biweekly and weekly cetuximab in patients with metastatic colorectal cancer: a meta-analysis.2020Anticancer Research
Comparative efficacy and safety of radiotherapy/cetuximab versus radiotherapy/chemotherapy for locally advanced head and neck squamous cell carcinoma patients: a systematic review of published, primarily non-randomized, data.2020Therapeutic Advances in Medical Oncology
Concurrent cisplatin or cetuximab with radiotherapy in patients with locally advanced head and neck squamous cell carcinoma; a meta-analysis.2020Medicine

Clinical Practice Guidelines

Document TitleYearSource
Treatment of metastatic colorectal cancer: ASCO guideline.2022Journal of Clinical Oncology