Immunotherapy Demonstrates Superiority in Head-and-Neck Cancer

A phase 3 trial of nivolumab showed promising results in patients with relapsed metastatic head-and-neck cancer.

The randomized, open-label, phase 3 CheckMate 141 trial enrolled 361 patients with platinum refractory relapsed head and neck cancer. Participants received either nivolumab or standard-of-care chemotherapy with methotrexate, docetaxel, or cetuximab.

The analysis included 129 patients who completed questionnaires at baseline, 9 weeks, and 15 weeks. The questionnaire included topics such as the patient’s physical ability to perform their role in life (job, etc), and their emotional, cognitive, and social wellbeing.

Participants were also asked about symptoms such as shortness of breath, nausea, pain, and fatigue. The overall score was calculated for global health. The findings were presented at the European Society for Medical Oncology meeting and published in the New England Journal of Medicine.

In each of the treatment arms, the questionnaire results were tracked from baseline to 9 weeks and 15 weeks. The results between the 2 treatments arms at 9 weeks and 15 weeks were also compared using previously defined score differences defining a clinically relevant gap.

The results of the study showed that at 9 weeks and 15 weeks, patients who received nivolumab saw both function and symptom burden maintained, or even improved, compared with baseline. In patients who received standard-of-care chemotherapy, they experienced worse scores in all areas at 9 and 15 weeks compared with baseline.

Researchers compared the scores between the 2 study arms at 9 and 15 weeks, and found that for most of the function and symptom areas, nivolumab showed a clinically significant benefit over standard-of-care chemotherapy, according to the study.

“Nivolumab not only prolongs life but it does so while maintaining function and reducing symptoms compared with standard of care chemotherapy,” said lead study author Kevin Harrington. “We need to drill down into the data to understand the reasons for these findings. The data suggest that the superior clinical activity of nivolumab maintains patient-reported outcomes, but it also likely that nivolumab is a kinder treatment that is associated with fewer side effects which can have a negative effect on quality of life.

“We’re used to the notion that for gain there has to be pain, and that we have to ask patients to accept more toxicity to get better outcomes. But immunotherapy with nivolumab gives better survival and allows patients to function at work and socially, and experience less pain and fatigue than with chemotherapy. This is a win-win scenario for patients and their doctors.”

Sandrine Faivre, medical oncologist at Beaujon University Hospital stated that the study’s findings demonstrate superiority over standard chemotherapy treatment options.

“This is the first study to show that an immunotherapy is superior to classical treatment options for improving quality of life and symptoms, on top of prolonging survival,” Faivre said. “I can now explain to my patients that nivolumab may help them to feel and function better in daily life.

“Nivolumab works in around one-third of patients with advanced head and neck cancer. We need biomarkers or biological criteria to identify patients most likely to benefit from this treatment so that unnecessary side effects and costs are avoided.”