Dr. Steven Powell and his colleagues saw an unmet need in the standard treatment for Sanford Health‘s head and neck cancer patients. And now, their effort to take a new approach has the potential to become a better standard of care for patients everywhere.
Their desire to find a way to cure more patients started with a mouse model study at Sanford Research. After over a year, that turned into a phase 1b study of 59 patients with advanced head and neck cancers that was led by the Sanford Health head and neck cancer team. In addition to receiving standard chemotherapy and radiation treatment, the patients also were given Keytruda, or pembrolizumab, an immunotherapy medication.
About 70% of head and neck cancers are caused by the human papillomavirus (HPV), according to the U.S. Centers for Disease Control and Prevention. The 34 HPV-positive patients in the Sanford study had a 97% two-year survival rate. Dr. Powell, the principal investigator for the study, said that for the majority of patients enrolled, the average survival rate probably would have been 75% otherwise.
‘Step closer to finding a better treatment’
“Head and neck cancers are tough to beat, and the results of this study bring us one step closer to finding a better treatment to cure our patients and improve their quality of life,” said Powell, who’s also an associate scientist at Sanford Research and a medical oncologist specializing in lung, head and neck cancers and melanoma at Sanford Health.
The researchers observed the progression and survival rates for the patients and evaluated the safety and efficacy of adding Keytruda to the standard radiation and chemo combination. The study found that the drug was well-tolerated and safe. That’s especially welcome news, considering 77% of patients receiving chemoradiation for head and neck cancer have severe side effects, according to Dr. Powell.
For the HPV-negative patients, Dr. Powell said, the only conclusion that could be drawn so far is that treatment is at least equivalent to the expected survival rate. A longer-term analysis may yield more definitive results.
International clinical trials follow
Head and neck cancers are the sixth most common cancer worldwide. An estimated 13,500 people are diagnosed with HPV-positive head and neck cancers every year in the U.S., the CDC says. Many patients with advanced cases cannot have surgery to remove a tumor because of its size or the potential loss of structures in the throat or neck, so the radiation and chemo combination has been the standard treatment.
This first in-human study opened to an initial group of patients in 2016 and expanded in 2017, with collaborators at the University of California San Diego, when results showed early promise. The results of this study have led to several international phase 3 clinical trials using this approach.
“The trial conducted with the participation of patients in the Midwest could change the trajectory of how we treat and care for head and neck cancer patients around the world,” said W. Chad Spanos, M.D., a senior author of the study and a surgeon-scientist who leads the head and neck cancer team at Sanford Health.
The Sanford study will follow patients for five years, collecting blood and tumor samples to better understand how an individual’s genetic predisposition may affect the efficacy of the immunotherapy treatment. The research is supported by a five-year, nearly $11.7 million grant from the National Institutes of Health.
‘How do you build on that?’
Looking to the future, Dr. Powell hopes to build on the findings of the study.
“We didn’t cure every single patient on the study. So how do you build on that and develop a treatment that is one, going to cure more patients, and two, decrease side effects?” he said.
In the future, his team is interested in looking at perhaps starting immunotherapy before other treatments to reduce the size of the tumor and, in turn, the amount of chemotherapy and radiation given.
“This trial was really spawned out of doing what we thought was the best approach for our patients. And I think that’s what, as Sanford providers, we should do,” Dr. Powell said. “… That’s where you’re the most successful is when you build trials that fit your patient population.”
The results of the Sanford study were published in the Journal of Clinical Oncology.
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