ORIGINAL PAPER
Fluoropyrimidines plus Cisplatin versus Gemcitabine/ Gemcitabine plus Cisplatin in locally Advanced and metastatic Biliary Tract Carcinoma - A Retrospective Study

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Adina Croitoru1, Iulia Gramaticu1, Ioana Dinu1, Liana Gheorghe2, Sorin Alexandrescu3, Florina Buica1, Ioana Luca1, Gabriel Becheanu4, Vlad Herlea4, Iulia Simionov2, Doina Hrehoret3, Ioana Lupescu5, Irinel Popescu3, Mircea Diculescu2

1) Department of Medical Oncology;
2) Center of Gastroenterology and Hepatology;
3) "Dan Setlacec" Center of General Surgery and Liver Transplantation;
4) Department of Pathology;
5) Department of Radiology, Fundeni Clinical Institute, Bucharest, Romania


Abstract


Aim: This is a retrospective study of patients with advanced biliary tract carcinoma (BTC), who were treated with different regimens of chemotherapy.

Methods: We studied patients with advanced BTC registered at the Department of Oncology at the Fundeni Clinical Institute between 2004 and 2008. The following data were analyzed: rate of response, progression free survival (PFS) to first and second line of chemotherapy, overall survival (OS) and drug toxicity. Ninety-six patients were eligible having either advanced intra or extrahepatic cholangiocarcinoma, or gallbladder cancer with no prior chemotherapy.

Results
: Out of 96 patients, 57 (59.4%) received fluoropyrimidines (FP)+cisplatin and 39 (40.6%) gemcitabine (Gem)+/-cisplatin. The median PFS for FP+cisplatin was 5.9 months (95%CI 5-6.9) and for Gem+/-cisplatin 6.3 months (95%CI 5.4-7.1), p=0.661. Median OS for FP+cisplatin was 10.3 months (95%CI 7.5-13.1) and for Gem+/-cisplatin 9.1 months (95%CI 7.0-11.2), p=0.098. On disease progression, 46 patients received second line CT (Gem or FP+/-platinum compounds). Median OS for patients with FP based first line and Gem+/-cisplatin in second line was 19 months (95%CI 8.9-29) higher than for the reverse sequence: 13.2 months (95%CI 12-14.4), but not statistically significant (p=0.830). All patients were evaluated for toxicities. Most patients (75.5%) reported at least one adverse event.

Conclusion
: Our results through direct comparison of FP+cisplatin with Gem+/-cisplatin as first line treatment did not show any statistical differences in terms of rate of response, PFS and OS. However, our study showed that FP+cisplatin as first line and Gem based second line therapy gave a better OS rate.

Key words

Advanced biliary tract cancer - fluoropyrimidines - gemcitabine - cisplatin - second line chemotherapy.