Abstract 889P
Background
ICIs have demonstrated improved median overall survival (mOS) in patients with R/M HNSCC despite low response rates. Early Identification of patients that will derive benefit would be of high clinical utility. A strong rationale suggests a prognostic role for inflammatory biomarkers for ICIs.
Methods
Twenty variables, including 11 inflammatory markers at baseline and at 4 weeks post-treatment start were retrospectively assessed by univariate analysis in 61 patients with R/M HNSCC treated with ICIs and in a control cohort of 45 patients that never received ICIs. The most important prognosticators for OS were assessed by Least Absolute Shrinkage and Selection Operator (LASSO) analysis, included in a multivariate Cox-regression model and used to build a Head & Neck Immune Prognostic Index (HN-IPI).
Results
Dichotomised Neutrophil/lymphocyte ratio (NLR) (≥8 vs <8) and C-reactive protein (CRP) (≥50 mg/L vs <50mg/L) were the most significant predictors of OS at baseline and were selected for HN-IPI, also incorporating the kinetics of lymphocyte count at 4 weeks. HN-IPI good, intermediate, and poor-risk categories were associated with mOS of 11.8, 6.0, and 1.8 months (mo), respectively (p<0.0001; hazard ratio [HR] of good vs poor risk: 7311.4, 95%CI: 579.8-92203.9). 6-mo OS was 80%, 56% and 0% respectively. Importantly, HN-IPI identifies a subset of patients that per baseline NLR and CRP values would belong to a poor-prognosis group (mOS 2.3 mo), but their mOS improves to 6 mo if lymphocyte levels at 4 weeks increase or remain substantially stable. Patients whose lymphocyte levels significantly drop (≥25%) at 4 weeks represent a true poor-risk category (mOS: 1.8 mo). HN-IPI is also informative for PFS (p<0.0001) and is ICI-specific (p: 0.1143 for the chemotherapy-only cohort).
Conclusions
HN-IPI, combining baseline NLR and CRP with early lymphocyte count kinetics, is the first dynamic inflammatory index with a significant prognostic value in R/M HNSCC patients on ICIs. HN-IPI merits validation in independent cohorts and prospective clinical trials.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Leaders of Oncology Care (LOC).
Funding
Has not received any funding.
Disclosure
V. Formica: Financial Interests, Personal, Other, Honoraria: Merck; Financial Interests, Personal, Other, Honoraria: Amgen; Financial Interests, Personal, Other, Honoraria: Servier. A. Patrikidou: Financial Interests, Personal, Advisory Board: Basilea; Financial Interests, Personal, Advisory Board: Bristol-Myers-Squibb; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Advisory Board: Bayer; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Board: Janssen; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Other, Conference grant: Amgen. All other authors have declared no conflicts of interest.