Clinical biomarkers as predictors of immunotherapy (IT) benefit in recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) patients (pt)

Abstract Background Baseline derived neutrophil–lymphocyte ratio (dNLR) and LDH are prognostic biomarkers for IT in lung cancer. Immune-related adverse events (irAEs) have also been associated with improved outcomes. We investigated whether these factors and additional clinical and laboratory variables predict outcomes of R/M HNSCC pt treated with IT. Methods Retrospective review of R/M HNSCC pt treated with IT at VHIO from 2015 - 2019 was conducted. dNLR, LDH and variables related to host nutritional status (NS) body mass index (BMI ≥25) and albumin levels (Alb ≥4), were collected at baseline. IrAEs ≥G2 were assessed with CTCAE v.4.0. A cutoff value of dNLR ≥3 and LDH ≥1.5xULN was set by the maximization of the log-rank test. We calculated overall survival (OS) and progression free survival (PFS) with Kaplan-Meier method and constructed univariate Cox models. Results Overall, 64 pt were identified, median age was 61y, all ECOG ≤1, 23 treated with single agent IT (36%) or IT combinations 41 (64%). According to the location: 15 pt (23%) had oral cavity carcinoma, 21 (33%) oropharynx, 9 (14%) hypopharynx, 16 (25%) larynx and 3 (5%) unknown primary origin. P16 IHQ was present in 13 pt (21%). Median prior lines were 2 (1 - 6) and median follow-up was 23 months (m) (CI95% 18 - NA). Incidence of IrAEs ≥G2 was 19%. Median PFS was 4.4 m (CI95% 3 – 8.5) and median OS was 10.9 m (CI95% 7.2 – 15.8). Longer PFS and OS were observed in pt achieving tumor response vs stable/progressive disease (HR: 0.07; 15.9 – NA; p  Conclusion In our cohort, Alb levels and BMI were strong factors predicting outcomes of IT-treated R/M HNSCC pt. These results suggest that NS should be considered when stratifying pt in ongoing trials. In addition, the lack of prognostic value of dNLR and LDH levels deserves further investigation. Legal entity responsible for the study Vall du0027Hebron Institute of Oncology. Funding Has not received any funding. Disclosure All authors have declared no conflicts of interest.