Drug updated on 4/17/2024
| Dosage Form | Injection (intravenous; 100 mg/50 mL [2 mg/mL] or 200 mg/100 mL [2 mg/mL]) |
| Drug Class | Epidermal 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
- 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 Title | Year | Source |
|---|---|---|
| Erbitux (cetuximab) Prescribing Information. | 2021 | Eli Lilly and Company., Indianapolis, IN |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Treatment of metastatic colorectal cancer: ASCO guideline. | 2022 | Journal of Clinical Oncology |