According to results presented at the 2007 annual meeting of the American Society of Clinical Oncology (ASCO), the addition of Erbitux (cetuximab) to platinum-based chemotherapy improves survival in patients with advanced head and neck cancer compared to chemotherapy only.  

Erbitux is a monoclonal antibody targeted against the epidermal growth factor receptor (EGFR). It is currently approved for the treatment of locally or regionally advanced squamous cell head and neck cancer in combination with radiation therapy.  

Researchers from Europe conducted a clinical trial referred to as the EXTREME trial (Erbitux in First-Line Treatment of Recurrent or Metastatic Head and Neck Cancer). This trial included 442 patients with stages III, IV or recurrent squamous cell head and neck cancer who could not undergo local therapy. One-quarter of patients had cancer of the larynx and nearly half of the patients had cancer of the pharynx; the vast majority of patients (399) were men. 

Patients were randomized to either six cycles of 5-fluorouracil (Adrucil) plus either carboplatin (Paraplatin) or cisplatin (Platinol) every three weeks, or the same chemotherapy regimen with the addition of cetuximab at an initial dose of 400 mg/m2 then 250 mg/m2 weekly. Patients were treated with cetuximab until disease progression or unacceptable toxicity.  

• Mean survival was 10.1 months for patients treated with cetuximab compared to only 7.4 months treated with chemotherapy only HR=0.797, p=0.0362).
• The only reported side effect that was notable for those treated with cetuximab was an acne-like rash.  

The researchers concluded that the addition of Erbitux to platinum-based chemotherapy as initial therapy improves survival for patients with advanced head and neck cancer. Furthermore, the addition of Erbitux did not significantly increase adverse events compared to chemotherapy alone.  

Reference: Vermorkin J, et al. Erbitux Extends Survival of Patients with Recurrent or Metastatic SCCHN when Added to First Line Platinum Based Therapy -- Results of a Randomized Phase III (Extreme) Study. Proceedings from the American Society of Clinical Oncology Conference. Chicago/IL. 2007. Abstract #