In continuing efforts to develop effective treatments with less impact on quality of life, Miami Cancer Institute, part of Baptist Health, is participating in a clinical trial to reduce by more than half the radiation dosage for head and neck cancers related to the human papillomavirus (HPV). About 70 percent of oropharyngeal cancers are now associated with HPV.
The trial, which launched at the Institute on Nov. 1, is available through the Memorial Sloan Kettering Cancer Alliance. Miami Cancer Institute, a member of the Alliance, is one of only three cancer centers in the nation participating, and is the only participating site in the southeastern United States.
“We want to remake the standard of care for HPV-related head and neck cancers,” says Noah Kalman, M.D., MBA, the Miami Cancer Institute study site’s principal investigator and lead head and neck radiation oncologist.
Current radiation protocols for head and neck cancers derive their treatment paradigms from smoking-related cancers. The typical treatment involves seven weeks of radiation delivering 70 gray, the international unit of radiation dose. The treatment, paired with chemotherapy, can be grueling.
“Radiation is the mainstay of treatment — it’s very effective, but it’s very toxic, both during and after treatment. Patients have issues with swallowing, dry mouth, taste and tooth decay. It can be rough treatment to go through,” Dr. Kalman explains.
Because HPV-related head and neck cancers respond better to treatment, with improved cure rates relative to other head and neck cancers, research is focusing on whether treatment can succeed with less intense treatment, Dr. Kalman says. “The goal in the field is to deescalate treatment while maintaining the same excellent disease control. This study is unique in reducing the radiation dose to 30 gray instead of 70 gray.”
Patients who participate in Miami Cancer Institute’s study will undergo a special PET scan after two weeks of treatment using a specific radiotracer produced at Memorial Sloan Kettering in New York. Because of the tracer’s limited shelf life, it must be administered the same day it is made. Arranging the logistics of such a transfer from New York to Florida has been challenging, Dr. Kalman says, but definitely worth the effort because of the potential impact on patients’ short- and long-term quality of life.
The mid-treatment scan will determine how much progress patients have made and how much more treatment they require. Early results indicate that roughly 80 percent of patients will be able to finish radiation treatment after three weeks, Dr. Kalman says. The other 20 percent of patients would need to continue treatment for the full seven weeks. Patients who participate would be closely monitored for several years to check for any recurrence and to manage treatment associated side effects.
Other studies around the country are investigating the effectiveness of reducing the length of treatment to five or six weeks. The new trial at Miami Cancer Institute takes that even further. “Going from seven weeks to three should substantially reduce the toxicities of treatment,” Dr. Kalman explains. “It’s cutting edge —trying to achieve the same cancer control, but with significantly fewer side effects.”
The study is currently enrolling participants. For more information, visit clinicaltrials.gov (NCT03323463). Miami Cancer Institute has been part of the Memorial Sloan-Kettering Alliance since the Institute opened in 2017. The Alliance is a cooperative designed to support high-quality cancer care and research in community settings, providing patients with access to clinical trials unavailable elsewhere.