Abstract 938P
Background
Lung Immune Prognostic Index (LIPI) based on derived neutrophil–lymphocyte ratio (dNLR) and LDH levels is a validated prognostic factor in IT exposed populations. We investigated whether LIPI and additional clinical and tumor characteristics predict outcomes in R/M HNSCC pts treated with IT.
Methods
Review of a prospective database of R/M HNSCC pts treated with IT at VHIO from 2014-2019 was conducted. dNLR, LDH and other variables related to host NS [Prognostic Nutritional Index (PNI) = 10 × albumin (g/dL) + 0.005 × lymphocyte count (cells/mm)], body mass index and phosphate (Phos) levels were collected at baseline and treated as continuous variables. The primary endpoint was progression free survival (PFS) calculated with the Kaplan-Meier method. Univariate and multivariable Cox models were fitted and the proportion of explained variation of each factor in the final PFS model was calculated.
Results
Out of 101 pts, median age was 64y, 96% ECOG ≤1, treated with single agent IT 38% or IT combinations 62%. Only 8% were HPV-related oropharynx cancer. Baseline NGS was available for 44 tumors: 28 (64%) were TP53 mutated and 10 (23%) had cyclin pathway alterations. Median prior lines were 1 (range 1 - 5) with a median follow-up of 23.8 months (m) and a median OS of 15 m (CI95% 11.6 - 2.5). Median PFS on IT was 4 m (CI95% 3 – 6.5). Significantly better PFS was observed for the absence of liver metastases (HR: 0.37; 0.16 - 0.85; p= 0.02), ECOG 0 vs ≥1 (HR: 0.64; 0.4 – 1; p= 0.05), PNI index (HR: 0.94; 0.9 – 0.97; p= 0.001) and Phos levels (HR: 0.45; 0.25 – 0.8; p= 0.007). However, dNLR (HR: 1.0; 0.94 – 1.1; p= 0.9) and LDH (HR: 1.0; 0.91 – 1.1; p= 0.93) were not significantly associated with PFS. In a multivariable model, ECOG, PNI and Phos levels remained independent prognostic factors. Of note, the relative contribution of NS (PNI + Phos) in the multivariable PFS prediction model was 67%.
Conclusions
In our cohort, ECOG, PNI and phosphate levels were the strongest variables associated with IT PFS in R/M HNSCC pts. These results suggest that parameters informative of NS should be considered when stratifying pts in IT trials. The lack of predictive power for LIPI determinants deserves further investigation.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Vall d'Hebron Institute of Oncology.
Funding
Comprehensive Program of Cancer Immunotherapy and Immunology (CAIMI) supported by the Banco Bilbao Vizcaya Argentaria Foundation (BBVA Foundation) (grant 89/2017) - La Caixa Foundation (LCF/PR/CEO7/50610001) -Cellex Foundation providing research facilities and equipment.
Disclosure
O. Mirallas: Honoraria (self): Kyowa Kirin. M. Vieito: Advisory/Consultancy: Debio; Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Advisory/Consultancy: TFS; Travel/Accommodation/Expenses: Merck Serono. I. Gardeazabal: Travel/Accommodation/Expenses: Merck; Travel/Accommodation/Expenses: MSD. G. Villacampa Javierre: Speaker Bureau/Expert testimony: Merck Sharp & Dohme; Advisory/Consultancy: AstraZeneca. J. Martin Liberal: Speaker Bureau/Expert testimony: Astellas; Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Bristol-Myers Squibb; Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: MSD; Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Novartis; Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Pierre Fabre; Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Pfizer; Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Roche; Travel/Accommodation/Expenses: Ipsen. R. Dienstmann: Advisory/Consultancy: Roche; Advisory/Consultancy: Boehringer Ingelheim; Speaker Bureau/Expert testimony: Roche; Speaker Bureau/Expert testimony: Ipsen; Speaker Bureau/Expert testimony: Amgen; Speaker Bureau/Expert testimony: Servier; Speaker Bureau/Expert testimony: Sanofi; Speaker Bureau/Expert testimony: Merck Sharp and Dohme; Research grant/Funding (institution): Merck; Research grant/Funding (institution): Pierre Fabre. E. Garralda: Research grant/Funding (institution): Novartis; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): Roche; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): Thermo Fisher; Advisory/Consultancy: Ellipses Pharma; Advisory/Consultancy: Neomed Therapeutics1 Inc; Advisory/Consultancy: Boehringer Ingelheim; Advisory/Consultancy: Janssen Global Services; Advisory/Consultancy: SeaGen; Advisory/Consultancy: TFS; Advisory/Consultancy: Alkermes; Advisory/Consultancy, Travel/Accommodation/Expenses: Bristol-Myers Squibb; Advisory/Consultancy, Speaker Bureau/Expert testimony: Merck Sharp and Dohme; Advisory/Consultancy: Menarini; Advisory/Consultancy: Glycotope. E. Felip: Advisory/Consultancy: Guardant Health; Advisory/Consultancy: Janssen; Speaker Bureau/Expert testimony: Medscape; Advisory/Consultancy: Merck KGaA; Advisory/Consultancy: Merck Sharp and Dohme; Advisory/Consultancy: Novartis; Advisory/Consultancy: Pfizer; Speaker Bureau/Expert testimony: priME Oncology; Advisory/Consultancy: Roche; Advisory/Consultancy: Samsung; Advisory/Consultancy: Takeda; Speaker Bureau/Expert testimony: Touchime; Advisory/Consultancy: GSK; Advisory/Consultancy: Bayer; Research grant/Funding (institution): Grant for Oncology Innovation (GOI); Research grant/Funding (institution): Fundación Merck Salud. I. Braña: Advisory/Consultancy, Leadership role: Orion Pharma; Speaker Bureau/Expert testimony, Leadership role: BMS; Speaker Bureau/Expert testimony, Leadership role, Travel/Accommodation/Expenses: AstraZeneca; Advisory/Consultancy, Travel/Accommodation/Expenses: Merck Serono; Advisory/Consultancy, Leadership role: Rakutan Pharma; Speaker Bureau/Expert testimony: Roche; Leadership role: Celgene; Leadership role: Gliknik; Leadership role: GSK; Leadership role: Janssen; Leadership role: KURA; Leadership role: MSD; Leadership role: Novartis; Leadership role: Pfizer; Leadership role: Shattuck; Leadership role: Northern Biologics; Leadership role: Nanobiotics. All other authors have declared no conflicts of interest.