The head and neck lung immune prognostic index (HN-LIPI): A prognostic score for immune checkpoint inhibitors (ICI) in recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) patients

Background LIPI, based on derived NLR (neutrophils/(leucocytes-neutrophils)) and lactate dehydrogenase (LDH) level, has been correlated to ICI outcomes in advanced non small cell lung cancer. We evaluated if HN-LIPI could offer the same role in R/M SCCHN. Methods This is a multicentric (9 European centers) retrospective study including R/M SCCHN patients (pts) treated with ICI from September 2014 to May 2019 and a control cohort (N = 83) only treated with chemotherapy. Baseline biological and clinicaldata were collected from medical records. According to dNLR>3 and LDH > upper limit of normal, HN-LIPI defines 3 groups (Good: 0 factor; Intermediate: 1 factor; Poor: 2 factors).The primary endpoint was overall survival (OS), and secondary endpoints was progression free survival (PFS). Results We included 273 pts (84% male, 84% smokers and 87% with PS ≤ 1, median age 59 years). Primary tumor locations were: oropharynx (37%), oral cavity (23%) and hypopharynx (17%). p16by immunohistochemistry was positive in 33% oropharynx pts. ICI were administered in 53% of patients as monotherapy and in 47% in combination. The median number of prior lines was 2 (1-7) with 65% of pts receiving ≥2. Median follow up of 13.2 months (mo).The median (m) PFS and OS were 2.84 mo [2.53-3.52] and 11.8mo [9.4-15.8]. dNLR >3 was associated to poor OS(HR 1.6, 95%CI: 1.1-2.3) but not with PFS (p = 0.11). LDH was not associated with endpoints. Median OS for good, intermediate and poor LIPI groups were: 15.9mo, 8.9mo and 6.2mo, respectively (p=.03). In univariate analysis, Intermediate and Poor risk groups were associated with OS (HR:1.5 95%CI:1.1-2.2 and HR:2 95%CI:1.0-4. respectively ). There was trend to better objective response rate in the good risk group compared with intermediate and poor (36%, 22% and 18%, p = 0.09). Conclusions Baseline HN-LIPI is associated with worse OS for ICI in R/M SCCHN but not with PFS. Control cohort results and multivariate models will be further presented at the congress, which would elucidate the prognostic and/or predictive impact in R/M SCCHN population. Legal entity responsible for the study Neus Baste. Funding Has not received any funding. Disclosure V. Cristina: Advisory / Consultancy: Merck-Serono; Advisory / Consultancy: Ely Lilly; Advisory / Consultancy: Servier; Advisory / Consultancy: Celgene; Travel / Accommodation / Expenses: Bayer; Travel / Accommodation / Expenses: Merck-Serono. A. Garcia Castano: Advisory / Consultancy: Roche; Advisory / Consultancy: Novartis; Advisory / Consultancy: MSD; Advisory / Consultancy: BMS; Advisory / Consultancy: Pierre Fabre; Speaker Bureau / Expert testimony: Roche; Speaker Bureau / Expert testimony: Novartis; Speaker Bureau / Expert testimony: MSD; Speaker Bureau / Expert testimony: BMS; Speaker Bureau / Expert testimony: Pierre Fabre. R. Mesia Nin: Advisory / Consultancy: Merck; Advisory / Consultancy: BMS; Advisory / Consultancy: MSD; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Roche; Advisory / Consultancy: Nanobiotix; Speaker Bureau / Expert testimony: Merck; Speaker Bureau / Expert testimony: BMS; Speaker Bureau / Expert testimony: MSD. M. Taberna: Non-remunerated activity/ies: Merck Serono; Non-remunerated activity/ies: AstraZeneca; Travel / Accommodation / Expenses: Merck Serono; Travel / Accommodation / Expenses: Nanobiotics; Travel / Accommodation / Expenses: AstraZeneca; Travel / Accommodation / Expenses: MSD; Travel / Accommodation / Expenses: Bristol-Myers. B. Besse: Travel / Accommodation / Expenses: AbbVie; Travel / Accommodation / Expenses: Amgen; Travel / Accommodation / Expenses: AstraZeneca; Travel / Accommodation / Expenses: Biogen; Travel / Accommodation / Expenses: Blueprint Medicine; Travel / Accommodation / Expenses: BMS; Travel / Accommodation / Expenses: Celgene; Travel / Accommodation / Expenses: Eli Lilly; Travel / Accommodation / Expenses: GSK; Travel / Accommodation / Expenses: Ignyta; Travel / Accommodation / Expenses: IPSEN; Travel / Accommodation / Expenses: MERCK; Travel / Accommodation / Expenses: KGaA; Travel / Accommodation / Expenses: MSD; Travel / Accommodation / Expenses: Nektar; Travel / Accommodation / Expenses: Onxeo; Travel / Accommodation / Expenses: Pfizer; Travel / Accommodation / Expenses: Pharma Mar; Travel / Accommodation / Expenses: SANOFI; Travel / Accommodation / Expenses: Spectrum pharmaceuticals; Travel / Accommodation / Expenses: Tiziana Pharma; Travel / Accommodation / Expenses: Takeda. N. Baste-Rotllan: Advisory / Consultancy, Travel / Accommodation / Expenses: Merck Serono; Advisory / Consultancy, Travel / Accommodation / Expenses: AstraZeneca; Advisory / Consultancy, Travel / Accommodation / Expenses: Nanobiotics; Advisory / Consultancy, Travel / Accommodation / Expenses: Bristol-Myers Squibb; Travel / Accommodation / Expenses: MSD. All other authors have declared no conflicts of interest.