Opdivo, Reirradiation May Delay Head and Neck Cancer Progression

For certain patients with head and neck cancer, treatment with Opdivo and reirradiation led to better delayed progression.

Among patients with recurrent head and neck cancer, treatment with the immune checkpoint inhibitor Opdivo (nivolumab) administered alongside reirradiation resulted in more than 60% of patients experiencing progression-free survival (PFS; when a patient lives without their disease spreading or worsening) at one year, according to a study published in JAMA Oncology.

Study findings showed that 51 evaluable patients with recurrent nonmetastatic disease (cancer that has not spread outside the neck) or second primary disease (a new primary cancer in a patient who has previously had a treated cancer) with specified clinical outcomes based on a recent large retrospective series of patients receiving re-irradiation, when followed for a median of 24.5 months, had an estimated one-year PFS rate of 61.7%. The median PFS was 20.7 months, while the estimated two-year PFS rate was 43.2%.

“The question of how to treat locally recurrent [when cancer recurs where it started or in nearby lymph nodes] head and neck cancer that is nonmetastatic, and that has failed the first course of radiation, continues to be an area of investigation, as we don't really have an established standard and we have not really been able to elaborate on the role of immunotherapy in this particular clinical scenario,” study co-author Dr. Nabil Saba, a professor in the Department of Hematology and Medical Oncology at Emory University School of Medicine in Atlanta, told CURE® in an interview.

“Our paper is a first step, I think, in trying to answer this question, ‘What about future trials?’ Should immunotherapy be combined with radiation? There are some who believe that the radiation does not add much in terms of improving survival as once you benefit from immunotherapy you may be actually achieving good outcomes.”

Patients in the study received 30 to 33 treatments with intensity-modulated radiation therapy (IMRT) for six to six and a half weeks as well as intravenous treatment with Opdivo two weeks prior to beginning radiation, every two weeks for five cycles during radiation, then every four weeks for a total of 52 weeks of treatment, researchers noted.

Opdivo, according to the National Cancer Institute, is a form of immunotherapy that prevents cancer cells from suppressing the function of the immune system, thereby allowing the patient’s own body defenses to attack and kill cancer cells.

The Food and Drug Administration approved Opdivo for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after platinum-based therapy in 2016.

“To our knowledge, this nonrandomized controlled trial is the first prospective clinical trial of IMRT-based reirradiation therapy in combination with concurrent and maintenance [Opdivo] in patients with locoregionally recurrent HNSCC,” researchers wrote in JAMA Oncology. “These results suggested a potential improvement in PFS at one year compared with the best available historical control [data] with IMRT alone.”

Researchers reported that 100% of patients enrolled in the trial experienced at least one side effects of any grade, with the most common, fatigue, reported among 42, or 82.4%, of patients.

Grade 3 (severe) or higher side effects were experienced by 28 (54.9%) of patients, with the most common being a low lymphocyte (a type of white blood cell) count (six patients), anorexia (four patients) and difficulty swallowing (four patients). The most common treatment-related grade 3 or higher side effects included two patients with a decreased lymphocyte count and one patient each with diarrhea, colitis, infective myositis (muscle infection), nausea, mucositis (inflammation of the lining of the digestive system) and myasthenia gravis (a neuromuscular disease that causes muscle weakness).

For more news on cancer updates, research and education, don’t forget to subscribe to CURE®’s newsletters here.