Phase II Randomized Trial of Surgery Followed by Chemoradiation Plus Cetuximab for High-Risk Squamous Cell Carcinoma of the Head and Neck (RTOG 0234)
It is known that post-operative concurrent chemotherapy and radiation improves survival and local control (prevention of the cancer recurring in the same area it was initially located) in patients with high-risk squamous cell carcinoma of the head and neck. The combination of cetuximab and chemotherapy appears to be beneficial in metastatic head and neck cancer. This study looked at the safety and feasibility of chemotherapy, radiation and cetuximab in postoperative patients with squamous cell cancer (SCC) of the head and neck.
Participants had stage III or IV SCC of the head and neck; most were located in the oral cavity or oral pharynx. They received radiation and cetuximab, and were then randomized to either cisplatin or taxotere chemotherapy. There was a high rate of side effects (80% of patients experienced grade 3 or 4 toxicities), including mucositis (in 1/3 of patients) and low blood counts. Overall, about 75% of patients tolerated the treatments, which was defined as completing 90% of the planned radiation, 95% of planned cetuximab, and 4 weeks of chemotherapy. Fewer patients tolerated the cisplatin regimen (75.5%) compared with 83.5% in the taxotere group.
The study does not have enough follow-up time to say if the therapy is effective in treating the tumor, just that it is tolerable, with significant side effects. Efficacy data is expected at a later date.
Partially funded by an unrestricted educational grant from Bristol-Myers Squibb.