Biliary Tract Carcinoma: Real-World Evidence in a Developing Country

Background Biliary tract carcinoma (BTC) is underreported. This study describes the clinical characteristics and survival outcomes of BTC patients at six institutions in Colombia. Methods This is an observational, retrospective, multicenter, and real-life study of BTC patients. Baseline demographics, clinical characteristics, and treatment patterns were collected. A Kaplan-Meier analysis was used to estimate overall survival (OS), event-free survival (EFS), and progression-free survival (PFS). Multivariable Cox proportional hazards regression analyses for OS were performed in the overall cohort and in patients who received first-line treatment. Results A total of 214 BTC patients were included of which 136 were women (63.6%). Gallbladder carcinoma accounted for n=102 (47.7%), extrahepatic cholangiocarcinoma for n=59 (27.5%), and intrahepatic cholangiocarcinoma for n=53 (24.8%). Radical surgery was performed in 127 (59.3%) patients, 34 (26.8%) of whom remained relapse-free. First-line treatment for advanced disease was given to 116 patients (54.2%). Gemcitabine alone or in combination was used in 102 (87.9%) patients. The median EFS and OS were 16.4 months (95%CI: 12.3-20.6) and 21.5 months (95%CI: 14.2-28.8), respectively. Among patients initially diagnosed with metastatic disease, the median OS was 7.9 months (95%CI: 6.9-8.9). In 55 patients treated with gemcitabine-cisplatin as first-line therapy, the median OS was 9.6 months (95%CI: 5.5-13.7). In multivariable analysis, Eastern Cooperative Oncology Group performance status ≥2 and CA 19-9 >100U/mL were independently associated with worse OS. Conclusions In Colombia, patients with BTC face a poor prognosis, even in the early stages. Survival with gemcitabine-cisplatin for advanced disease is lower than that reported in clinical trials. These real-world data inform expectations for physicians and patients in Colombia.