Prognostic Impact of Advanced Lung Cancer Inflammation Index (ALI) on Immunotherapy Outcomes in Recurrent or Metastatic Nasopharyngeal Carcinoma: A Multicenter Post Hoc Analysis

Shihong Xu,1,* Zheran Liu,1,* Ge Song,1,* Yiyan Pei,1 Murong He,2 Junyou Ge,3 Yan Qing,3 Youneng Wei,3 Meiying Shao4 1Department of Biotherapy, Cancer Center, West China Hospital, Sichuan University, Chengdu, People’s Republic of China; 2Shenzhen Middle School, Shenzhen, People’s Republic of China; 3Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., Chengdu, People’s Republic of China; 4West China School of Public Health and West China Fourth Hospital, Sichuan University, Chengdu, People’s Republic of China*These authors contributed equally to this workCorrespondence: Meiying Shao, West China School of Public Health and West China Fourth Hospital, Sichuan University, 18#, 3rd Section, Renmin South Road, Chengdu, Sichuan, 610041, People’s Republic of China, Tel +86 028 85508286, Fax +86-28-85423278, Email [email protected]: The Advanced Lung Cancer Inflammation Index (ALI) is a newly introduced index that integrates inflammatory and nutritional statuses to assess malignancies. This study investigates the association between pre-immunotherapy ALI levels and clinical outcomes in recurrent or metastatic nasopharyngeal carcinoma (R/M NPC) patients receiving immune checkpoint inhibitors (ICIs) therapy.Patients and Methods: We conducted an exploratory post hoc analysis of a multicenter, single-arm Phase 2 trial enrolling 153 patients with R/M NPC. This study evaluated the prognostic utility of the pretreatment ALI for overall survival (OS) and progression-free survival (PFS), along with its association with treatment response to ICIs. The optimal ALI cutoff was empirically derived from this cohort. Propensity score matching (PSM) was also applied to assess the independent association between pretreatment ALI and clinical outcomes.Results: Patients with low ALI scores demonstrated shorter OS and PFS compared to the high ALI group (OS: HR=4.07, p< 0.001; PFS: HR=2.17, p< 0.001). Low ALI was also associated with a lower disease control rate (DCR) (25.0% vs 58.7%, p=0.002), but showed no significant correlation with objective response rate (ORR) (15.6% vs 23.1%, p=0.361). In multivariate analysis incorporating propensity score-matched cohorts (n=62), ALI retained prognostic value for OS (HR=3.74, p=0.001) and PFS (HR=1.84, p=0.049).Conclusion: Our findings suggest that pretreatment ALI as a promising prognostic biomarker for R/M NPC patients treated with ICIs. Given the exploratory post hoc nature of this analysis, the use of an empirically derived cutoff without external validation and the modest sample size of the matched cohort, these results warrant validation in future prospective studies.Keywords: ALI, nutrition, ICIs, prognosis