Phase II study of vinorelbine/cetuximab in patients with recurrent/metastatic squamous cell carcinoma of the head and neck progressing after at least two chemotherapy regimens.

The aim of the present study was to identify a potentially effective new treatment regimen for patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck in disease progression after at least two previous chemotherapy regimens. The "novel" regimen was Cetuximab administered weekly plus Vinorelbine on days 1, 8, 15 every 28days. The regimen was administered to patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck previously treated with surgery, radiotherapy or both and progressing after at least two chemotherapy regimens. Twenty-four patients with histologically confirmed tumors of oral cavity, oropharynx, hypopharynx and larynx were enrolled. All patients were stage IV and 91.6% had an ECOG PS 0-1. After 3 cycles of treatment 23 patients (95.8%) were evaluable for response: 4 patients had partial response; 12 stable disease and 7 progressive disease. Disease control rate was 69.5%. At a median follow-up of 21.3months, the median progression-free survival was 5.8months. Median duration of response was 5.2months. At May 2010, 11/24 (45.8%) patients were alive. The safety profile was quite good. The present study shows that the combination of Vinorelbine and Cetuximab in recurrent and/or metastatic squamous cell carcinoma of the head and neck patients is effective, feasible and has a good safety profile. Our findings warrant further investigation in a wider patient population.