Cetuximab plus radiotherapy in patients with unresectable locally advanced squamous cell carcinoma of head and neck region--a open labelled single arm phase II study.

PURPOSE: To evaluate feasibility, safety and outcome of cetuximab concurrent with radiotherapy in locally advanced head-neck cancer.

MATERIALS AND

METHODS

Between March 2007 and January 2008 eligible cases of locally advanced unresectable (Stage IV) squamous cell carcinoma of head and neck were enrolled in this single arm, open labeled phase II Study. They were treated with cetuximab for a duration of 8 weeks and concomitant RT for 7 weeks (starting one week after initiating Cetuximab).

RESULTS

A total of 19 eligible patients were enrolled. The median age of patients was 53 years, all patients happening to be male. The performance status of the patients was 0/1. The location of the primary tumor was oropharynx in 12 cases, oral cavity in 4, larynx in 2, and hypopharynx in one case. The overall response rate (ORR) was 68.42% and the overall survival at 2 year was 84 %. All 13 patients who completed two years follow-up after completion of study treatment continued to be alive with no evidence of disease progression. One patient also remained alive with progressive disease.

CONCLUSIONS

Cetuximab concurrent with radiotherapy is a safe and effective option in advanced head-neck cancer patients.