In this study, patients with squamous-cell cancer of the head and neck that had come back or spread to other parts of the body were given either standard chemotherapy alone or the same chemotherapy with the drug cetuximab. Adding cetuximab raised how long patients lived on average from 7.4 months to 10.1 months and made it more likely that the tumour would shrink. Side effects such as skin reactions and reactions during the infusion can happen, and severe blood infection (sepsis) was more common in the cetuximab group; decisions about treatment should be made with your treating doctor.
First line for recurrent or metastatic disease; standard in tumours without PD-L1 expression
| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Cetuximab | First dose 400 mg/m² (120 minutes), then 250 mg/m² (60 minutes); or 500 mg/m² every 2 weeks | IV | Weekly, 1 hour before chemotherapy |
| Up to 6 cycles | |||
| Cisplatin or carboplatin | Cisplatin 100 mg/m² or carboplatin AUC 5 | IV | Day 1 |
| 5-Fluorouracil | 1000 mg/m² per day | Continuous IV infusion | Days 1 to 4 |
| Maintenance | |||
| Cetuximab | 250 mg/m² | IV | Weekly |
The same use; without immunotherapy
| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Phase 1: 6 cycles | |||
| Cisplatin 100 mg/m² or carboplatin AUC 5 | IV | Day 1 | |
| Fluorouracil | 1000 mg/m² a day | Continuous infusion | Days 1 to 4 |
| Cetuximab | 400 mg/m² (first dose), then 250 mg/m² | IV | Weekly |
| Phase 2 | |||
| Cetuximab | 250 mg/m² | IV | Weekly |
As in EXTREME.
Dose source:.
Doses follow the trial protocol, guideline or official drug label (source given in the notes of each regimen). Before prescribing, check blood counts, renal and hepatic function, drug interactions and the patient’s condition, and adjust the dose according to the drug label.
Cisplatin 100 mg/m² IV on day 1, or carboplatin AUC 5 mg/mL×min as a 1-hour IV infusion on day 1 (investigator's choice), plus fluorouracil 1000 mg/m² per day as a continuous IV infusion on days 1 to 4; every 3 weeks, up to 6 cycles (220 patients).
The same chemotherapy (up to 6 cycles) plus cetuximab 400 mg/m² as a 2-hour IV infusion (first dose), then 250 mg/m² as a 1-hour infusion weekly. After 6 cycles, patients without progression (stable disease or response) continued weekly single-agent cetuximab until progression or unacceptable toxicity; if chemotherapy was delayed or stopped because of toxicity, weekly cetuximab continued (222 patients). Premedication: an H1 receptor antagonist; the cetuximab infusion should be completed 1 hour before chemotherapy (FDA label).
Source of the regimen details: Abstract of the paper, ClinicalTrials.gov NCT00122460 and the FDA label for Erbitux (DailyMed, sections 2 and 14)
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Patients with locoregionally recurrent or metastatic squamous-cell carcinoma of the head and neck, with no prior treatment for recurrent or metastatic disease (442 eligible patients). Randomisation was stratified by Karnofsky score (below 80 versus 80 or more) and prior chemotherapy; 88% had a Karnofsky score of 80 or more (FDA label).
Primary endpoint: overall survival (FDA label). Other endpoints: progression-free survival, objective response rate and adverse events.
The most common grade 3 or 4 adverse events in the chemotherapy-alone and cetuximab groups, respectively: anaemia (19% and 13%), neutropenia (23% and 22%) and thrombocytopenia (11% in both groups). Sepsis occurred in 9 patients in the cetuximab group and 1 patient in the chemotherapy-alone group (P=0.02). Of 219 patients receiving cetuximab, 9% had grade 3 skin reactions and 3% grade 3 or 4 infusion-related reactions. The paper reported no cetuximab-related deaths; however, the FDA label states that fatal cardiac disorders and/or sudden death occurred in 3% of the 219 patients in the cetuximab group and recommends monitoring of magnesium, potassium and calcium and caution in coronary artery disease, heart failure or arrhythmia.
This study showed that adding cetuximab to platinum–fluorouracil chemotherapy in the first-line treatment of recurrent or metastatic squamous-cell carcinoma of the head and neck improves overall survival. The exact status of this regimen in clinical guidelines and drug approvals should be checked separately, as the abstract does not mention it.
The abstract does not state the study's limitations. The increase in sepsis in the cetuximab group, together with skin toxicity and infusion-related reactions, should be considered in patient selection. Further details should be checked in the full text.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.
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