Biliary tract carcinoma: Real-world evidence in a developing country.

Abstract

494 Background: Biliary-tract-carcinoma (BTC) is rare, with limited data in Colombia. To fill this void, this study describes the clinical characteristics and survival outcomes of BTC patients treated at six institutions. Methods: This is a multicenter, longitudinal, observational study. Data of patients with BTC was analyzed retrospectively. Information regarding patient demographics and clinical characteristics, treatment patterns and survival outcomes was collected. The outcomes evaluated were overall survival (OS), event-free survival (EFS), and progression-free survival (PFS). Time-to-event endpoints were estimated using the Kaplan–Meier method. Results: Data from 214 BTC patients was analyzed, including 136 women (63.6%). The median age at diagnosis was 64 years (IQR:57.0–71.0). Primary tumor sites were gallbladder carcinoma (GBC) in 102 patients (47.7%), intrahepatic cholangiocarcinoma (iCCA) in 53 (24.8%), and extrahepatic cholangiocarcinoma (eCCA) in 59 (27.5%). The median follow-up was 16.7 months (IQR:9.1–47.3). Radical surgery was performed in 127 patients (59.3%), of whom 34 (26.8%) did not experience relapse. First-line systemic treatment for advanced disease was given to 116 patients (54.2%), with 102 (87.9%) receiving gemcitabine alone or in combination with other agents. For the entire cohort, the median EFS was 16.4 months (95%CI 12.3–20.6), and the median OS was 21.5 months (95%CI 14.2–28.8). Among patients initially diagnosed with metastatic disease, median OS was 7.9 months (95%CI 6.9-8.9). In the subgroup of 55 patients treated with gemcitabine plus cisplatin (GemCis) as first-line therapy, median OS was 9.6 months (95%CI 5.5-13.7). Conclusions: Patients with biliary-tract carcinomas in Colombia face poor prognosis, even in early stages. Survival with gemcitabine-cisplatin for advanced disease is lower than in clinical trials. This real-world data informs expectations for physicians and patients in Colombia. Funding: Funded by AstraZeneca. Overall survival by subgroups. Subgroups No. of patients Median (months) CI95% Stage I 36 57.8 (40.8-74.8) Stage II 49 41.4 (15.8- 67.0) Stage III 53 33.5 (21.5-45.6) Stage IV 75 9.7 (7.7-11.7) GemCis as first-line therapy 55 9.6 (5.5-13.7)