P-0137 Comparison of the Efficacy Between the Gemcitabine/Cisplatin (GP) and Epirubicin/Cisplatin/5-Fluorouracin (ECF) for the Advanced Biliary Tract Cancer: Retrospective Analysis

Abstract

ABSTRACT Introduction Patients with biliary tract cancers have a poor prognosis with a median survival of less than 1 year. The combined epirubicin, cisplatin, and 5-fluorouracil (ECF) regimen had been an upfront regimen for several decades in the patients with advanced biliary tract cancer. However, since 2009, gemcitabine plus cisplatin (GP) has become the standard treatment based on the phase III clinical trial. We retrospectively analyze the efficacy and safety of the GP comparing the ECF in advanced biliary tract cancer. Methods All patients, diagnosed as biliary cancer and gall bladder cancer were retrospectively reviewed between May 2008 and December 2011 at Seoul St. Mary's Hospital, Catholic University. In ECF group, chemotherapy was given as follows: Epirubicin 50 mg/m2, cisplatin 60 mg/m2 on day 1 and 5-fluorouracil 1000 mg/m2 daily as a continuous infusion from day 1 to day 3, and In GP, gemcitabine was treated with 1000 mg/m2 on Day 1, 8 and cisplatin 75 mg/m2 on day 1. Results There were 28 patients in ECF and 43 patients in GP. Median age was 61 (46-76) in ECF, 62 (41-81) in GP. For response rate, partial response (PR) was achieved in 3 (10.7%) in ECF, and 1 in GP (2.3%). Disease control rate, defined as PR plus stable disease (SD) was similar in both group, 14 (50.0%) in ECF and 21 (48.8%) in GP. Progression free survival (PFS) has no significant difference in both group, 2.0 months in ECF and 2.4 months in GP. Overall survival (OS) also shows no significant difference, 5.1 months in ECF and 4.7 months in GP respectively. As far as toxicities profiles, ECF had more profound grade 3/4 hematologic toxicities than GP: For neutropenia: 20 patients (66.7%) versus 10 patients (23.2%). For anemia: 8 patients (26.7%) versus 4 patients (9.3%). For thrombocytopenia: 13 patients (43.3%) versus 9 patients (20.9%). Febrile neutropenia was observed in 4 patients (13.3%) in ECF and among them, treatment related death was occurred in 1 patient as the result of septic shock. Conclusion The ECF and GP regimen demonstrated similar clinical outcome and there was no difference in PFS and OS, while ECF has more profound hematologic toxicities than GP in the patients with advanced biliary tract cancer. This is limited study with retrospective comparison and small sample size. For better clinical outcome, new trial with other combination should be warranted.