Adjuvant Gemcitabine-cisplatin Combination for Biliary Tract Cancer: A Real Life Experience

Aim: Biliary tract cancers (BTCs), including gallbladder and cholangiocarcinomas, are aggressive malignancies with poor long-term survival despite surgical resection. The efficacy of adjuvant therapy in BTCs remains controversial, particularly in the absence of consistent phase 3 data supporting its survival benefit. Methods: We conducted a retrospective, single-center study including 49 patients who underwent surgery for BTC and received adjuvant chemotherapy between 2013 and 2022. Patients with stage 1 disease, neoadjuvant treatment, unresectable/metastatic disease, or missing pathology were excluded. Survival outcomes were analyzed using Kaplan-Meier and Cox regression methods. Results: The median overall survival (mOS) for the entire cohort was 44.8 months. The gemcitabine-cisplatin (GemCis) group had significantly longer mOS (71.5 months) than patients receiving other regimens (41.8 months; p=0.033). Advanced T stage, lymph node involvement, and tumor, node, metastasis stage 3 were associated with poorer survival. In multivariate analysis, treatment other than GemCis [hazard ratio (HR): 2.38; p=0.040] and stage 3 disease (HR: 3.32; p<0.01) were independent risk factors for decreased mOS. Conclusion: Our findings suggest that the gemcitabine-cisplatin combination may confer a survival advantage in selected patients with BTCs, especially younger individuals with good performance status. These results support further investigation in randomized controlled trials to clarify the role of gemcitabine-cisplatin in the adjuvant setting.