Association of Pretreatment Albumin-bilirubin Grade With Hepatotoxicity and Efficacy in EGFR-TKIs Therapy for NSCLC

Hiroki Arihara; Hidetsugu Nagamatsu; Yuji Hayakawa; Hiroki Mase; Tomoyuki Araya; Toshiyuki Kita

doi:10.21873/cdp.10417

Association of Pretreatment Albumin-bilirubin Grade With Hepatotoxicity and Efficacy in EGFR-TKIs Therapy for NSCLC

Cancer Diagn Progn. 2025 Jan 3;5(1):95-104. doi: 10.21873/cdp.10417. eCollection 2025 Jan-Feb.

Authors

Hiroki Arihara^{1

2}, Hidetsugu Nagamatsu³, Yuji Hayakawa^{4

5}, Hiroki Mase⁶, Tomoyuki Araya⁷, Toshiyuki Kita⁷

Affiliations

¹ Department of Clinical Pharmacy and Healthcare Science, Faculty of Pharmacy, Institute of Medical, Pharmaceutical and Health Science, Kanazawa University, Kanazawa, Japan.
² Department of Clinical Research, National Hospital Organization Kanazawa Medical Center, Kanazawa, Japan.
³ Department of Pharmacy, Handa City Hospital, Handa, Japan.
⁴ Department of Education and Innovation Training for Pharmacy, National Center for Geriatrics and Gerontology, Obu, Japan.
⁵ Department of Pharmacy, National Hospital Organization, Nagoya Medical Center, Nagoya, Japan.
⁶ Department of Pharmacy, National Hospital Organization, Nagara Medical Center, Gifu, Japan.
⁷ Department of Respiratory Medicine, National Hospital Organization Kanazawa Medical Center, Kanazawa, Japan.

Abstract

Background/aim: The albumin-bilirubin (ALBI) grade is an assessment tool for hepatic function and prognosis in patients with hepatocellular carcinoma (HCC). However, its significance in patients with non-small cell lung cancer (NSCLC) treated with an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) remains unclear. We retrospectively investigated the relationship between pre-treatment ALBI grade and hepatotoxicity and treatment efficacy in patients with NSCLC receiving EGFR-TKIs.

Patients and methods: We analyzed data from 182 patients with NSCLC treated with EGFR-TKIs. Patients were categorized into ALBI grades 1/2a and 2b/3 groups. We examined the association between ALBI grade, hepatotoxicity, and time to treatment failure (TTF) using univariate and multivariate analyses.

Results: In the univariate Kaplan-Meier analysis, ALBI grade was not associated with hepatotoxicity (log-rank p=0.56). This finding was consistent with the multivariate analysis of patients treated with gefitinib and erlotinib (n=158). However, In the univariate Kaplan-Meier analysis, the median TTF for the ALBI grade 1/2a group was 10.6 months, compared to 5.8 months for the ALBI grade 2b/3 group (hazard ratio=1.66, 95% confidence interval=1.19-2.33, p=0.003). Multivariate analysis confirmed that ALBI grade 2b/3 (hazard ratio=1.64, 95% confidence interval=1.16-2.30, p<0.01) was independently associated with shortened TTF.

Conclusion: Pretreatment ALBI grade classification can predict efficacy in patients with NSCLC treated with EGFR-TKIs.

Keywords: Non-small cell lung cancer; albumin-bilirubin grade; epidermal growth factor receptor; hepatotoxicity; time to treatment failure; tyrosine kinase inhibitors.