Head and neck cancer encompasses a group of diseases that include cancers of the mouth, throat, larynx (voice box), sinuses, nasal cavity and salivary glands. The primary causes of these cancers are alcohol consumption, infection with human papillomavirus (HPV) and tobacco use (including smokeless tobacco). Indeed, according to the Head and Neck Cancer Alliance, 85% of head and neck cancers are linked to tobacco use. And the combination of alcohol and tobacco greatly increases the risk of head and neck cancer.
Symptoms of these diseases can vary based on the cancer’s location but may include a lump or sore that does not heal, a persistent sore throat, difficulty swallowing and changes in the voice. Early detection and treatment are crucial for improving the prognosis and survival rates of those who are affected.
“Oral, head and neck cancers together make up the sixth most common cancer diagnosed worldwide,” said Amanda Hollinger, executive director of the Head and Neck Cancer Alliance, an advocacy organization. “We need to find better ways to diagnose and treat these cancers.”
Approaches to treating head and neck cancers
The U.S. National Cancer Institute estimates that 71,110 oral cavity, pharynx and larynx cases will be diagnosed in 2024, and some 16,110 people will succumb to these diseases.
Treatment protocols typically adhere to a standardized system of care: surgery, radiation, and chemotherapy for localized cases, followed by aggressive second- and third-line therapies for metastatic or recurrent tumors. That said, the approach to treatment varies depending on the specific organ or organ systems that are affected by the cancer. (The Head and Neck Cancer Alliance provides links to the PDQ Cancer Information for Health Professionals documents, produced by the National Cancer Institute, for a variety of head and neck cancers.)
While today there are a variety of approved methods to treat these cancers, many patients do not respond or have incomplete or partial responses to the current standard of care.
Recent clinical data from Japan utilizing boron neutron capture therapy (BNCT) has generated transformational results. A study published in 2021 showed that 71% of patients who received BNCT for recurrent or locally advanced head and neck cancer responded to treatment, with 24% (n=5) experiencing a complete response.
How BNCT works
How BNCT can make an impact
BNCT provides targeted radiation to tumor cells. A reaction between the boron-10 and neutrons at the site of the tumor releases alpha particles in cancer cells that destroy cellular DNA, leading to cell death. Alpha particles are high energy, but they only travel a short distance, approximately the diameter of a cell. This precision, which is designed to target cancer cells while leaving healthy cells unharmed, provides advantages compared to other forms of radiation therapy or anti-cancer treatment that is systemic — that is, it travels throughout the body.
An additional benefit of BNCT is that the therapy typically consists of one or two treatments compared to other radiation therapy approaches, which can require between 30 to 50 treatments. Reducing the number of treatments greatly improves both quality of life and the financial impact on patients and their families who often must take extended periods of time off work to receive many doses of traditional radiation therapy.
In the case of head and neck cancers, BNCT also has the potential to eliminate or significantly reduce the need for surgery, which can be disfiguring and affect a patient’s ability to chew, swallow and talk.
Advances in BNCT
Over the last century, research and clinical development in BNCT has seen progress in the U.S. and in many other countries, particularly in Japan.
But it is only recently that the convergence of advanced science and technology has fueled widespread interest in BNCT, with countries like Finland, China, Italy, Israel, and Argentina developing their own BNCT programs and constructing research reactors, or other neutron sources, specifically designed for BNCT.
2020 was a first for BNCT, as Steboronine, developed by Stella Pharmaceuticals, was approved in Japan for the treatment of unresectable locally advanced or locally recurrent head and neck cancer.
In June 2020, BNCT became a therapy covered by Japan’s national health insurance system for treatment of advanced or locally recurrent head and neck cancer.
BNCT has progressed in other countries as well. In 2011, researchers at University Central Hospital, in Helsinki, Finland, reported one of the first cases of a head and neck cancer patient treated with BNCT as a first-line therapy, followed by chemoradiation. Nine months after BNCT application, the 53-year-old patient showed “no evidence of disease at endoscopy or in a biopsy,” the researchers wrote in the journal Radiotherapy and Oncology.
Similar results were reported in 2020, when researchers from Japan’s Osaka Medical College and Kawasaki Medical School, writing in the journal Applied Radiation and Isotopes, found “extremely high response rates” — between 60 and 100 percent — when BNCT was used as a first-line treatment for certain head and neck cancers.
Amid these statistics, interest among medical and radiation oncologists in North America in BNCT is once again on the rise. In Ontario, Canada, Dr. Ming Pan, a radiation oncologist at Windsor Regional Hospital, and Dr. Drew Marquardt, an associate professor of biophysics at the University of Windsor, are leading efforts to bring BNCT to Canadian patients.
“Often plagued by lackluster and controversial clinical success, research in this field has cycled through periods of high interest to times where it seemed like little progress was being made,” they wrote recently in the Canadian Journal of Physics.
“However, due to worldwide interdisciplinary collaboration … consistent improvements have been made both in boron delivery agents and neutron production.”
What’s more, while BNCT is currently used for recurrent oncology cases, there may be benefits to using BNCT as a first-line treatment for head and neck cancers due to the reduced burden on patients and potential reduction in side effects.
“There’s a compelling argument to be made to support moving BNCT earlier in the cancer-treatment paradigm, especially if it may reduce the need for disfiguring surgery, or limit severe adverse events associated with other treatments,” said Dave Greenwald, Ph.D., chief executive officer of Aviko Radiopharmaceuticals and vice president, business development at Deerfield Management. “For instance, if BNCT had a reduced likelihood of causing mucositis and xerostomia,1 two extremely uncomfortable side effects that patients who receive radiotherapy can experience, that may be a reason to consider using BNCT as a first-line treatment.”
We believe that recent scientific and technological innovations and subsequent clinical results in Japan and Finland have shown that BNCT can have a positive impact for patients with head and neck cancers, and we are working together with our partners to bring this modality to patients in need in the U.S.
1. Mucositis is the painful inflammation and ulceration of the mucous membranes lining the digestive tract, often occurring as a side effect of chemotherapy or radiation therapy. Xerostomia is extreme dry mouth due to reduced or absent saliva production that can result from radiation therapy.
Aviko Radiopharmaceuticals is portfolio company of investment funds managed by Deerfield Management Company. Aviko Radiopharmaceuticals’ products have not received authorization from the FDA or any other regulatory authority and they are not available to patients.
