Cetuximab therapy for head and neck squamous cell carcinoma: a systematic review of the data.

Objective: To review the current state of the data on the use of cetuximab in head and neck squamous cell carcinoma (HNSCC).

Data Sources: The National Center for Biotechnology Information's PubMed and the Cochrane collection.

Review Methods: Search terms included cetuximab and head and neck cancer. These results were reviewed, and a second search was performed using limits: meta-analysis, randomized controlled trial, and clinical trial.

Results: The literature search yielded 412 articles. Fifteen were identified for analysis. For patients with recurrent/metastatic disease who received combination chemotherapy in phase I/II trials, the overall response (OR) was 18.7% (95% confidence interval [CI], 10.4%-27.0%). Phase III trial data for combination chemotherapy in recurrent/metastatic disease showed OR to be 17.0% (95% CI, 12.6%-21.4%) for platinum-based regimens and 34.2% (28.6%-39.7%) for platinum-based regimens with cetuximab. For this same group, the estimated aggregate hazard ratio comparing platinum-based therapy plus cetuximab to platinum therapy alone was 1.10 (95% CI, 0.78- 1.54), indicating no significant improvement in overall survival in the aggregate analysis. Combination chemoradiation with cetuximab in both phase I/II trials and the single phase III trial shows enhanced responsiveness, but the data are difficult to interpret because it is not used with standard-of-care regimens for advanced-stage disease.

Conclusion: Early evidence has shown cetuximab to be effective in the treatment of HNSCC, and it should be used to enhance, but not replace, current treatment paradigms until further phase III data are available.