Abstract: Objective To investigate the predictive value of Kirsten rat sarcoma viral oncogene homolog (KRAS) gene mutation in patients with middle and advanced primary hepatic carcinoma (PHC) treated by drug‐eluting beads transarterial chemoembolization (DEB-TACE). Methods The clinical data of 158 patients with middle and advanced PHC treated with DEB-TACE from January 2020 to January 2022 were retrospectively analyzed. Tumor tissue samples were obtained and paraffin embedded before DEB-TACE, and KRAS gene mutation status was detected. The relationship between the mutation status of KRAS gene and clinicopathological features, the short-term efficacy of DEB-TACE and the prognosis of the patients was analyzed. Results Among 158 patients, KRAS gene mutation was detected in 41 cases (25.95%), all mutations were in exon 2, including 38 patients with codon 12 mutation and 3 patients with codon 13 mutation. KRAS gene mutation was significantly correlated with tumor differentiation, China liver cancer staging (CNLC), AFP level, and intrahepatic metastasis (all P<0.05). The DEB-TACE objective response rate (ORR)(31.71% vs. 71.79%) and disease control rate (DCR)(68.29% vs. 86.32%) of patients with mutant type (KRAS-MT) were significantly lower than those with wild-type (KRAS-WT) (both P<0.05). Receiver operating characteristic (ROC) curve analysis showed that the sensitivity and specificity of KRAS mutation status in predicting DEB-TACE efficacy were 78.80% and 76.40%, and the area under the curve (AUC) was 0.873(P=0.000, 95%CI: 0.764～0.936). The median overall survival (OS) in KRAS-MT patients was shorter than that in KRAS-WT patients (P<0.001). Multivariate Cox risk regression analysis showed that patients with low tumor differentiation (OR=2.014), CNLC stage Ⅲa (OR=4.742), intrahepatic metastasis (OR=3.861), and KRAS-MT (OR=5.137) had a higher risk of death after DEB-TACE treatment (all P<0.05). Conclusion KRAS gene mutation is associated with the short-term efficacy and prognosis of DEB-TACE in patients with middle and advanced PHC, and can be used as a predictor of DEB-TACE efficacy and prognostic survival.

Key words: KRAS gene, Primary hepatic carcinoma, DEB-TACE, Prognostic survival