ESMO 2016: Nivolumab Maintains Function and Reduces Symptoms in Relapsed Metastatic Head and Neck Cancer
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 by Harrington et al at the 2016 European Society for Medical Oncology (ESMO) Congress in Copenhagen, Denmark (Abstract LBA4) and published by Ferris et al in The New England Journal of Medicine.
CheckMate 141 and Patient-Reported Outcomes
CheckMate 141 is a randomized, 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 [Erbitux]). As previously reported, nivolumab improved overall survival by an average of 2.5 months.
Investigators at ESMO presented the results of patient-reported outcomes, including functional capacity and symptoms. The analysis included 129 patients who completed the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), EORTC Head and Neck Cancer module (QLQ-H&N35), and the EuroQol five dimensions’ questionnaire (EQ-5D) at baseline, 9 weeks, and at 6-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 well-being. 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 9 weeks and 15 weeks. The investigators also compared the results between the two treatment arms at 9 weeks and 15 weeks using previously defined score differences defining a clinically relevant gap (for some domains it was a gap of 7 points, while for others, it was a gap of 10 points).
Study Findings
For patients receiving nivolumab, both function and symptom burden was 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 two treatment arms at 9 and 15 weeks, they found that for most of the function and symptom areas, nivolumab offered a significant clinical benefit over standard-of-care chemotherapy.
“Nivolumab not only prolongs life, but it does so while maintaining function and reducing symptoms compared with standard-of-care chemotherapy,” said lead author Kevin Harrington, MBBS, MRCP, FRCR, FRCP, PhD, DIC, joint Head of the Division of Radiotherapy and Imaging, at the Institute of Cancer Research, London, and Consultant Clinical Oncologist at The Royal Marsden NHS Foundation Trust.
“We need to drill down into the data to understand the reasons for these findings,” he continued. “The data suggest that the superior clinical activity of nivolumab maintains patient-reported outcomes, but it is also likely that nivolumab is a kinder treatment that is associated with fewer side effects that can have a negative effect on quality of life.”
“We’re used to the notion that for gain there has to be pain—that we have to ask patients to accept more toxicity to get better outcomes,” said Dr. Harrington. “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.”
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
