Objectives: The aim of this study was to determine the efficacy and safety profile of gemcitabine plus cisplatin in patients with immunohistochemically proven unresectable cholangiocarcinoma.
Patients and methods: Between March 2002 and December 2004, a total of 24 patients with immunohistochemically proven cholangiocarcinoma were entered in this study. Treatment consisted of gemcitabine 1000 mg/m2 intravenous infusion on day 1 and 8 and cisplatin 70 mg/m2 intravenously on day 1 every 3 weeks.
Results: Seventy-one cycles of treatment were given, with a median of 3 cycles (range, 2-6 cycles). Five patients had a partial response (PR), 12 patients had stable disease (SD), and 7 patients progressed during treatment. A median survival of 9.30 months (range, 6.43-12.17) was obtained hematologic and nonhematologic toxicities were generally acceptable. However, there was one treatment-related mortality caused by thrombotic thrombocytopenia purpura (TTP) associated with gemcitabine and cisplatin.
Conclusions: The combination chemotherapy of gemcitabine and cisplatin had a modest effect and was a well tolerated treatment of patients with immunohistochemically proven metastatic or unresectable cholangiocarcinoma.