Nivolumab maintains function and reduces symptom burden in patients with recurrent metastatic head and neck cancer

An analysis of the patient reported outcomes from the CheckMate 141 trial, presented at ESMO 2016, indicated that nivolumab maintained function and reduced the symptom burden in patients with relapsed metastatic head and neck cancer (HNC). In the presented analysis, the symptoms and quality of life of patients in CheckMate 141 were assessed using several questionnaires, including one specifically designed for patients with HNC. For patients receiving nivolumab, it was shown that both function and symptom burden were maintained or even improved at 9 and 15 weeks compared to baseline. In contrast, patients receiving standard of care chemotherapy had worse scores in all areas at 9 and 15 weeks compared to baseline.

Patients with platinum refractory recurrent or metastatic HNC have a median survival of 6 months or less and suffer from their disease and its treatment. Accordingly, maintaining a good quality of life is a key treatment goal in this setting. CheckMate 141 is a randomized, open label phase III trial in which 361 patients with platinum refractory, relapsed HNC were treated with nivolumab or standard of care chemotherapy (methotrexate, docetaxel or cetuximab). As previously reported, nivolumab improved the overall survival in this study by 2.5 months on average. The analysis presented at ESMO 2016 included 129 patients who completed questionnaires at baseline, 9 weeks and at six-week intervals during the treatment. These questions covered functional areas, such as the physical ability of patients 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. Following these questionnaires, an overall score was calculated reflecting the global health of patients. For patients receiving nivolumab, both function and symptom burden were maintained or even improved at 9 and 15 weeks compared to baseline. In contrast, patients receiving standard of care chemotherapy had worse scores in all areas at 9 and 15 weeks compared to baseline. When the investigators compared the scores between the 2 treatment arms at 9 and 15 weeks, they found that for most of the function and symptom areas, nivolumab gave a clinically significant benefit over standard of care chemotherapy. Compared to chemotherapy, nivolumab significantly delayed the time to clinically relevant score deterioration (TTD) (p<0.05) for global health, physical ability, role in life, cognitive, and social functioning, fatigue, dyspnea, and insomnia (EORTC QLQ-C30) as well as pain, sensory problems, and mouth opening problems (QLQ-H&N35).

In conclusion, nivolumab not only prolongs life, but it does so while maintaining function and reducing symptoms compared with standard of care chemotherapy.

Reference

Harrington K, Ferris R, Shaw J, et al. Patient-reported outcomes (PROs) in recurrent or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN) treated with nivolumab or investigator's choice: checkmate 141. ESMO 2016; Abstract LBA4_PR.