Dr. Bonner published a study of 424 patients in a 2006 NEJM. They had stage 3 or 4 disease that had not metastasized and were randomly assigned to receive radiation alone or radiation plus weekly cetuximab. The radiation dose was the same for all but differed in fractionization. Median survival for the cetuximab group was 49 months compared with 29 months for the radiation alone group. Of the former, 55% survived for three years, compared with 45% of the latter. The cetuximab group also had better locoregional control, but both had metastasis at about the same rate.
Explore This IssueAugust 2008
The Erbitux in First-Line Treatment of Recurrent or Metastatic Head and Neck Cancer (EXTREME) trial was presented at the 2007 American Society for Therapeutic Radiology and Oncology (ASTRO) Annual Meeting. It endeavored to determine if adding cetuximab to platinum-based chemotherapy is clinically beneficial; 442 patients with stage 3 or 4 cancer were enrolled. Half received 5-FU plus carboplatin or cisplatin, and the other half received the same regimen plus cetuximab. The cetuximab group survived a median of 10.1 months compared to 7.4 months for the chemo-alone group.
This is the first demonstration of a survival improvement in the palliative setting for any therapy in head and neck cancer, said Marshall R. Posner, MD, Medical Director of the Head and Neck Oncology Program at Dana Farber Cancer Institute. Moreover, standard therapy cannot be used long term because many patients eventually develop numbness and problems with their immune system. Cetuximab can be continued for longer and thus can be more effective for palliation.
Despite these two trials, there is no definitive conclusion about the clinical benefits of cetuximab. For this reason, Dr. Bonner and colleagues conducted a retrospective review of 29 patients at the University of Alabama to compare addition of cetuximab or platinum-based chemotherapy to RT.
There was no significant difference between the two treatment regimens. Thus, said Dr. Bonner, Cetuximab with RT may be comparable to chemo with RT, which means it is an important option. Moreover, it is less toxic, and may be beneficial for patients at a lower risk of distant metastases and who are unsuitable for platinum-based chemotherapy.
©2008 The Triological Society