Nivolumab ( Opdivo ) maintains function and reduces symptoms in treatment of relapsed metastatic head and neck cancer, according to results from the CheckMate 141 trial presented at the ESMO 2016 Congress in Copenhagen and published in the New England Journal of Medicine.
CheckMate 141 is a randomised, open label phase III trial in which 361 patients with Platinum refractory relapsed head and neck cancer received treatment with Nivolumab or standard of care chemotherapy ( physician’s choice of Methotrexate, Docetaxel or Cetuximab ).
As previously reported, Nivolumab improved overall survival by an average of 2.5 months.
The analysis included 129 patients who completed questionnaires at baseline, nine weeks and at six week intervals during treatment. Questions covered functional areas, such as their physical ability to perform their role in life ( job, etc ) and their emotional, cognitive and social wellbeing. They were also asked about symptoms such as fatigue, nausea, pain and shortness of breath. An overall score was calculated for global health.
Within each treatment arm the questionnaire results were tracked from baseline to nine weeks and 15 weeks. The investigators also compared the results between the two treatment arms at nine weeks and 15 weeks using previously defined score differences defining a clinically relevant gap ( for some domains it was a gap of seven points while for others it was a gap of ten points ).
For patients receiving Nivolumab, both function and symptom burden was maintained or even improved at nine and 15 weeks compared to baseline. In contrast, patients receiving standard of care chemotherapy had worse scores in all areas at nine and 15 weeks compared to baseline.
When the investigators compared the scores between the two treatment arms at nine and 15 weeks, they found that for most of the function and symptom areas, Nivolumab gave a clinical significant benefit over standard of care chemotherapy.
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.
Nivolumab works in around one-third of patients with advanced head and neck cancer. Biomarkers or biological criteria to identify patients most likely to benefit from this treatment are needed. ( Xagena )
Source: ESMO, 2016