OKLAHOMA CITY – A newly approved National Cancer Institute-funded clinical trial aims to improve survival for head and neck cancer patients whose disease returns after radiation therapy – a setback that affects up to 40% of patients and is often associated with poor outcomes.
For these patients, surgery is currently the standard treatment, typically targeting tumors in the mouth, throat or lymph nodes of the neck. This Phase II trial will examine whether giving chemotherapy, or chemotherapy combined with immunotherapy, before surgery can improve survival compared with surgery alone.
"Even when a patient is a good surgical candidate, the operation is often aggressive and life-altering. It can mean losing the voice box, removing much of the tongue, or risking serious complications in the neck, and despite all that, outcomes are still not where we want them to be. We hope this trial identifies a treatment that will help patients live longer without the cancer returning," said Christina Henson, M.D., associate professor at the University of Oklahoma College of Medicine and radiation oncologist at the OU Health Stephenson Cancer Center. Henson is the radiation oncology chair for the trial, which will enroll patients in Oklahoma and across the United States.
Patients deemed surgical candidates will be randomly assigned to receive chemotherapy (carboplatin and paclitaxel) before surgery; the same chemotherapies plus the immunotherapy drug cemiplimab before surgery; or surgery alone. Cemiplimab, which harnesses the body's own immune system to fight the cancer, is a PDL1 inhibitor. The drug targets cancers that are positive for PDL1, a protein marker indicating the tumor may be vulnerable to immunotherapy. Most head and neck cancers are PDL1-positive, Henson said.
Henson's colleague Mark Newpower, Ph.D., an assistant professor in the OU College of Medicine, is the medical physics chair for the trial. Patients with especially high-risk cancer may receive radiation therapy following surgery.
"We have worked to standardize the technical details of this trial. It has been gratifying to contribute the institutional knowledge of our radiation oncology department," said Newpower, who is the lead proton physicist for OU Health Stephenson Cancer Center.
