Head and neck cancer includes a broad range of cancers that most often occur in the mouth, throat and voice box. Accounting for approximately 4 percent of all cancers in the United States, head and neck cancer has a poor prognosis and is more than twice as common among men as they are among women, according to the National Cancer Institute.
Standard course of treatment for head and neck cancer varies, depending on the type, location and size of the cancer. Treatment often involves surgery, radiation therapy, chemotherapy or a combination, with side effects that can negatively impact a patient’s quality of life. Some patients have trouble eating, talking or swallowing, and their physical appearance can be radically altered.
To improve standard of care and long-term outcomes for patients with head and neck cancer, also known as head and neck squamous cell carcinoma, Earle A. Chiles Research Institute, a division of Providence Cancer Institute of Oregon, is sponsoring an investigator-initiated clinical trial to evaluate the safety and efficacy of using pembrolizumab and stereotactic body radiation therapy (SBRT) in reducing the size or eradicating tumors prior to surgery. The combination of immunotherapy and radiation therapy is also known as neoadjuvant immunoradiotherapy or NIRT.
Phase II NIRT study opens to patients
This one-arm study is open to 28 patients with confirmed diagnosis of stage III-IVA HPV-negative head and neck cancer who have a surgical procedure planned and can safely undergo the combination of pembrolizumab and a short three-day course of radiation therapy.
Pembrolizumab is an immunotherapy used in patients with head and neck cancer that works by blocking the PD-1 pathway, thus helping T cells find and attack cancer cells.
Radiation therapy uses high-energy particles or waves, such as X-rays, gamma rays, electron beams or protons, to destroy or damage cancer cells. SBRT focuses radiation beams on the tumor only, minimizing damage to normal healthy tissue.
The use of pembrolizumab and SBRT before surgery may help shrink cancer or prevent it from coming back after surgery. The combination of these two therapies could also eliminate the need for daily radiation treatments and/or chemotherapy over a long period of time.
Earlier study showed promise
In an earlier NIRT study, also sponsored by Earle A. Chiles Research Institute, patients with HPV-positive head and neck cancers received neoadjuvant treatment using immunotherapy nivolumab with radiotherapy prior to surgery. The results, which were published in the Journal for ImmunoTherapy of Cancer, suggested the combination of nivolumab and radiotherapy were safe and effective in reducing tumor size in 90 percent of the patients treated. Among the entire study group, the major pathologic response was 86 percent, and the pathologic complete response (no sign of cancer) was 67 percent. As a result, only one patient needed radiation or chemotherapy after surgery.
R. Bryan Bell, M.D., D.D.S., FACS, FRCS(Ed), medical director of Providence Head and Neck Cancer Program and Clinic, is the principal investigator of the phase II NIRT study. Providence is the only location in the world currently recruiting patients.
“This important study represents a potential paradigm shift in how we treat patients with head and neck cancer,” said Dr. Bell. “Instead of surgery first, followed by six weeks of broad-field radiation therapy and chemotherapy that results in significant side effects, we aim to shrink the tumors with a short three-day course of radiation focused on the tumor only, combined with immunotherapy first, followed by surgery. We believe this may eliminate the need for lengthy and highly morbid post-operative chemoradiation, as well as enhance quality of life and survival.”
Learn more about the study here: Neoadjuvant Immunoradiotherapy in Head & Neck Cancer (NIRT 2-HNC)
For more information about this study or to refer a patient, please contact our Clinical Research office:
Head and neck cancer clinical trials
There are 20 head and neck cancer studies currently open to enrollment at Providence Cancer Institute Oregon. New research studies are added frequently. Please visit our website to see all studies in all cancer types available at Providence Cancer Institute.
Providence Head and Neck Cancer Clinic
The Providence Head and Neck Cancer Program offers world-class care for patients with benign and malignant tumors of the oral cavity (mouth), tongue, pharynx (throat), larynx (voice box), nose, paranasal sinuses, salivary glands and thyroid gland, as well as tumors at the skull base. Our medical and surgical oncology teams work collaboratively to start patients on treatment regimens very quickly. Through our innovative trials and translational research, we strive to elevate the current standard of care for cancer patients by offering advancements such as adoptive cellular therapy and pre-operative immunotherapy. To learn more, visit providenceoregon.org/hncancer.
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