Method
Design and Setting
This was a retrospective single-centre cohort study, conducted at a
single tertiary cancer centre.
Participants and Outcome Measures
Clinical records of 76 patients with histologically confirmed HNSCC and
confirmed disease progression within six month of prior platinum therapy
were reviewed to identify patient who had received one or more doses of
nivolumab in the recurrent or metastatic setting between February 2018
and August 2020. To determine the frequency with which multi-modality
radio-immunotherapy was administered in this population, radiotherapy
planning records were then reviewed to identify all patients who had
received radiotherapy within 8 weeks of a prior dose of nivolumab. To
determine the outcomes of patients following radio-immunotherapy,
clinical data was reviewed in this subset of patients.
Ethical Considerations
The clinical record review of patients with platinum resistant HNSCC
treated with nivolumab to identify those treated with
radio-immunotherapy was conducted as part of the institutional clinical
audit with the appropriate local institutional approvals. In accordance
with the UK Policy Framework for Health and Social Care Research,
subsequent data analysis was performed on anonymized data without any
patient level identifiable information and no specific consent was
acquired from each patient included in this study. For the inclusion of
anonymized medical photography in the data presentation, individual
patient consent was obtained under the MCRC Biobank Research Tissue Bank
Ethics (NHS NW Research Ethics Committee 18/NW/0092).