Impact of clinically diagnosed liver cirrhosis in patients with intrahepatic cholangiocarcinoma treated with systemic chemotherapy: a subgroup analysis of JCOG1113

Background The JCOG1113, a multicenter, randomized phase III trial in patients with advanced/recurrent biliary tract cancer showed the non-inferiority of gemcitabine plus S-1 to gemcitabine plus cisplatin. Although liver cirrhosis (LC) is a known risk factor for intrahepatic cholangiocarcinoma (ICC), few reports focus on the efficacy and safety of chemotherapy in ICC patients with LC.Methods We performed a subgroup analysis of ICC patients enrolled in the JCOG1113. The presence or absence of LC was evaluated based on clinical factors such as radiographic findings, medical history, laboratory data, and physical examination at enrollment. We evaluated differences in the safety and efficacy of chemotherapy according to the presence or absence of clinically diagnosed LC.Results Of the 94 eligible patients with ICC, 10 were clinically diagnosed with LC. In the non-LC/clinically diagnosed LC group, grade 3 or 4 neutropenia, anemia, decreased platelet count, and non-hematological adverse events were observed in 51.2%/60%, 15.5%/0%, 11.9%/40%, and 38.1%/30% patients. The median overall survival was 13.7 months in the non-LC group and 19.0 months in the clinically diagnosed LC group (hazard ratio [HR]: 0.969, 95% confidence interval [CI]: 0.482-1.948). The median progression-free survival was 5.9 months in the non-LC group and 7.1 months in the clinically diagnosed LC group (HR, 0.995; 95% CI, 0.513-1.929).Conclusion The results of this study indicated that eligible ICC patients with clinically diagnosed LC, as determined by clinical and CT imaging findings, did not exhibit any apparent safety or efficacy disadvantage compared to those without LC. The results of this subgroup analysis of JCOG1113 showed no apparent safety or efficacy disadvantage of clinically diagnosed LC in patients with ICC treated with systemic chemotherapy.