Increased alanine aminotransferase level as a predictive marker of hand-foot syndrome in patients receiving capecitabine: A retrospective cohort study

IntroductionHand-foot syndrome (HFS) is a common dose-limiting toxicity of capecitabine that impairs quality of life and can lead to treatment modification or discontinuation. Predictive markers for HFS remain unclear. This study aimed to identify clinical and biochemical factors associated with the development and severity of HFS in patients receiving capecitabine.MethodsWe conducted a retrospective cohort study of patients with breast, colorectal, or gastric cancer who received capecitabine between December 2017 and December 2019. Patients were eligible if they received at least one treatment cycle and had follow-up data for 12 weeks. HFS incidence and severity were assessed using CTCAE version 4.0. Associations between clinical factors and HFS were evaluated using univariate analysis and time-dependent Cox proportional hazards models.ResultsAmong 146 patients, 55 (37.7%) developed HFS: Grade 1 (n = 28), Grade 2 (n = 21), and Grade 3 (n = 6). No patients discontinued treatment due to HFS. In the prespecified model, cumulative capecitabine dose was not significantly associated with HFS. However, in exploratory analysis, increased alanine aminotransferase (ALT) levels were associated with both the development (HR: 1.02; 95% CI: 1.00-1.04; p = 0.02) and severity (HR: 1.03; 95% CI: 1.01-1.05; p = 0.01) of HFS.ConclusionsIncreased ALT may serve as a potential biomarker for predicting HFS risk in capecitabine-treated patients. This finding could aid in early identification and management of at-risk patients, improving treatment outcomes.