Squamous cell carcinoma of the head and neck (SCCHN) can be ranked as the sixth leading cancer by incidence worldwide (1,2). Every year, there are more than 550,000 patients diagnosed with head and neck cancers worldwide and around 300,000 related deaths (3). Squamous cell carcinomas represent 90% of cases and mostly arise from the epithelial lining of the oral cavity, oropharynx, larynx, and hypopharynx. SCCHN can be divided into three stages: early stage (I/II), locally advanced stage (III/IV) and recurrent or metastatic disease (4). At the time of diagnosis, only one-third of patients present with early-stage disease. This group of patients has a favorable prognosis and can often be treated by single modality therapy (radiotherapy or surgery) with cure rates of more than 90% for stage I and 70% for stage II (5,6,7). Unfortunately, the remaining two-thirds that represent the majority of cases present with locally advanced (LA) disease either stage III or IV (without distant metastasis) (8). …show more content…
The Danish Head and Neck Cancer Group (DAHANCA) conducted a phase III trial to evaluate the benefit of adding zalutumumab to radiotherapy. In this trial, 619 patients with SCCHN (89%with stage III-IV disease) were randomized to receive radiation (n=309) or radiation plus zalutumumab at 8 mg/kg (n=310). Zalutumumab was started one week prior to beginning radiation and continued weekly during radiation. The first results showed that the two arms did not show any difference in LRC (79% vs. 78%). Although patients with p16 positive tumors had better LRC (83% vs. 73% in those who were p16-negative) overall, there was no difference in outcomes based on p16 status in patients treated with zalutumumab (LRC - 83% in both p16 positive or negative groups). Also, zalutumumab arm had more mucositis, folliculitis and 11% patients withdrew from the study because of skin rash