Real-world outcomes for patients with recurrent or metastatic squamous cell carcinoma of the head and neck treated with nivolumab: A Galician multicentric study (Spain).

e18002 Background: Nivolumab has demonstrated efficacy in clinical trials of recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN). These results have been corroborated in real world studies in different populations. We describe the outcomes of 116 patients with R/M SCCHN in our clinical practice treated with Nivolumab in the main hospitals of the Galician health network (Spain). Methods: This multicenter study was carried out in nine hospitals that belong to the Galician Group of Head and Neck Cancer (GGCC). A total of 116 patients with R/M SCCHN who received nivolumab were recruited between January 2017 and June 2019. These patients were retrospectively reviewed. Overall survival (OS), progression-free survival (PFS) and the disease control rate (DCR) of the overall patient and specifically in the first, second and third lines, as well as toxicity, were evaluated. Results: Data from 116 patients were available. Most of them were males (91.37%) with a median age of 60 years (41-84 years). The primary tumor sites were oral cavity, oropharynx, hypopharynx and larynx. At first diagnosis, the majority of the patients had advanced disease (stage IV a/b/c 74.12%) and a performance status (PS ECOG) rate of 1 (64.65%). Owing to the real-world nature of the study, patients with poor performance status were also included (ECOG 2: 13.79% and ECOG 3: 0.86%). HPV and PDL1 status were not available for the majority of patients. The use of nivolumab in the first, second and third line was carried out in 20 (17.24%), 76 (65.52%) and 20 (17.24%) patients respectively. With a median follow-up of 14 months (1-69), in all patients (n = 116) the median progression-free survival (mPFS) was 2.30 months (95% CI 1.45 – 3.14) and the median overall survival (mOS) was 8.08 months (95% CI 5.93 – 10.23). DCR was 43% with 5% complete response (CR), 25% partial response (PR) and 15% stable disease (EE). The mPFS of the patients who received nivolumab in the first, second and third line was 3.9 (IC 95%1.01- 6.93), 3.6 (IC 95% 0.82-6.47) and 2.3 months (IC 95% 0.72-3.87) and the mOS was 6.8 (IC 95% 2.36-11.43), 8.5 (IC 95% 5,9 - 11.62) and 7.2 months (IC 95% 4.51-10.07) respectively. Drug-related adverse effects (grade 3/4) were observed in 21.27% and were controlled with steroid treatment. Conclusions: in this real-life study, the population is broader than the represented in the phase III CheckMate 141 trial, including patients with higher ECOG PS (0-3). These concordant results in the real-world setting in both efficacy and safety, support the use of nivolumab in this group of patients with R/M SCCHN.