With the exception of acneiform rash and infusion reactions, the incidence of grade 3 or greater toxic effects, including mucositis, did not differ significantly between the two groups.
Explore This IssueMay 2006
Although drugs like cetuximab definitely have fewer side effects than chemoradiation, the biologic therapy still is associated with some side effects such as rare hypersensitivity reactions and frequent acneiform rash, said Dr. Cohen. However, cetuximab did not seem to exacerbate the common toxic effects associated with radiotherapy of the head and neck, including mucositis, xerostomia, dysphagia, pain, weight loss, and performance-status deterioration, he said.
The study findings also indicated that cetuximab treatment does have its limitations, noted Dr. Strome. While the agent appeared to be beneficial for oral pharyngeal cancer, it did not make any difference in outcomes in patients with larynx or hypopharyngeal cancer, he said. Physicians need to keep in mind that how a newly given drug will affect specific sites of head and neck cancer may vary, he explained.
Chemoradiation continues to be the gold standard for fit, young patients with locally advanced cancer, but patients who can’t receive the standard of care because they aren’t medically fit need options like cetuximab. – -Roger B. Cohen, MD
Additionally, absolute survival at three years was 10%, and 5% of patients died within 60 days of completing therapy, he noted. At five years there will likely be a further fall-off in survival, Dr. Strome explained.
Cetuximab was not effective for metastatic disease in these patients, he added. If you could show me that the therapy decreased metastatic disease, it could be added to current regimens used with surgery, he said.
Additionally, only fractionated radiation therapy tended to have a response, and significant delayed severe radiation therapy complications occurred in 20% of cases, said Dr. Strome.
Future Cetuximab Research
Further studies through the Radiation Therapy Oncology Group and other research consortia will ask the key question of what will happen when investigators add cetuximab to chemotherapy in combination with radiation. In other words, triple therapy, said Dr. Cohen.
Additionally, a head-to-head comparison is necessary to determine whether cetuximab with radiation is as good as chemoradiation, he said.
Research will also evaluate patients who receive radiation therapy and chemotherapy after surgery due to a high risk of recurrence and see if they are also candidates for cetuximab in combination with radiation, Dr. Cohen said.
Changing the Standard of Care?
Chemoradiation continues to be the gold standard for fit, young patients with locally advanced cancer, said Dr. Cohen. But patients who can’t receive the standard of care because they aren’t medically fit need options like cetuximab, he explained.