Squamous cell carcinoma of the head and neck (SCCHN) is the most common head and neck tumor

with higher disease burden. More than 90% SCCHN patients with overexpression of epidermal growth factor receptor (EGFR). Therefore

one important method to inhibit EGFR signaling is through the specific high affinity binding of monoclonal antibody to EGFR. Among a variety of current drugs targeting EGFR and its pathway

cetuximab is the only targeted drug with definite efficacy and has been approved in China since February 2020 for the first-line treatment of recurrent/metastatic SCCHN (R/M SCCHN). With the gradual clinical application of cetuximab

the overall treatment model for patients with advanced SCCHN in China will continue to be improved and optimized. It is worth noting that although targeted and immune drugs have made great progress in the treatment of SCCHN

there are still many challenges. Consensus has not yet been reached for cetuximab on EGFR detection

drug application timing

combination regimen and suitable dosage

and adverse reaction management in the treatment of R/M SCCHN. This expert consensus has combined the literature and clinical practice in China to explain the efficacy and safety of cetuximab in first-line

second-line and combined immunotherapy of R/M SCCHN

and provides relevant recommendations regarding treatment strategies. It is hoped that this consensus will provide guidance for the standardized treatment of SCCHN patients with cetuximab and the optimization of clinical practice. After several rounds of discussion

experts of the consensus group have provided the following recommendations. In terms of molecular testing

patients with R/M SCCHN do not need routine testing of EGFR to inform clinical practice. Anti-EGFR monoclonal antibodies exert anti-tumor effect by inhibiting EGFR signaling. In first-line treatment

6 cycles of cetuximab in combination with cisplatin 75 mg/m

2

and 5-FU 750 mg/m

2

are recommended for platinum-tolerant patients

followed with cetuximab maintenance monotherapy after disease response or stable disease until progressive disease; 4 cycles of cetuximab in combination with platinum (cisplatin 75 mg/m

2

q3w) + docetaxel (75 mg/m

2

q3w) are recommended for patients with contraindications to 5-FU

inconvenience with continuous intravenous infusion

dihydropyrimidine dehydrogenase (DPD) deficiency and poor treatment compliance

followed with cetuximab maintenance monotherapy after disease response or stable disease until progressive disease; cetuximab in combination with paclitaxel weekly is recommended for platinum-intolerant patients until progressive disease; and cetuximab maintenance monotherapy is recommended for elderly patients in good condition after 6 cycles of cetuximab + carboplatin + 5-FU. Multiple clinical studies and real-world data have shown consistent high objective response rate (ORR) and survival benefit with cetuximab in combination with chemotherapy in first-line treatment. In second-line treatment

for patients who have failed first-line platinum-based chemotherapy

weekly treatment with cetuximab monotherapy or in combination with paclitaxel is recommended; for patients who have failed first-line immune checkpoint inhibitor (ICI) treatment

cetuximab in combination with chemotherapy is recommended

and the combined drugs should be adjusted based on previous drug exposure. In terms of safety

the most common adverse events related to cetuximab treatment include skin reaction

infusion reaction and electrolyte disturbance. Most skin reactions are mild and manageable with precautions and generally will resolve without sequelae upon discon

tinuation or dose reduction of cetuximab. Infusion reactions can be effectively controlled by precautions before infusion

close monitoring during and after infusion and timely intervention. Adverse reactions associated with cetuximab treatment are generally well tolerated and acceptable compared with those associated with chemotherapy alone. In addition

the use of cetuximab in combination with immunotherapy or new targeted drugs is explored and will bring more possibilities for R/M SCCHN patients in the future.