Palliative systemic chemotherapy with gemcitabine (GEM) and 5-fluorouracil (5-FU) as 24h-infusion in patients with advanced inoperable biliary tract cancer (UICC stage IV)

Abstract

e15633 Background: Due to the late diagnosis of biliary tract carcinomas in an advanced tumor stage, the application of palliative chemotherapy frequently remains as a possible treatment option. The aim of this study is to evaluate the efficacy and toxic side effects of a chemotherapy schedule consisting of GEM combined with 5-FU in patients (pts.) with metastatic biliary tract cancer. Methods: Evaluation of 35 pts. based on our prospective tumor registry data; essential inclusion criteria: histologically proven adeno-carcinoma, UICC stage IV, chemonaivity; all the pts. were presented in the interdisciplinary tumorboard of Erlangen University and were primarily non-curatively-resectable (n = 35); evaluation period: 11/1998 - 09/2008; treatment schedule: 1.000 mg/m2 of GEM as a 0.5h-infusion (inf.) combined with 2.000 mg/m2 of 5-FU as a 24h-inf. via port catheter on day 1, 8, 15 qd 22. Results: Median age: 64 years; men/women: n=18/17; ECOG 0/1/2: n=10/21/4; localisation: intrahepatic bile ducts: n=19, extrahepatic bile ducts: n=11; gall bladder: n=4; metastases: liver: 91.4%, lymph nodes: 51.4%, peritoneum: 28.8%, bones: 8.6%, intestine: 8.6%, skin: 2.9%, lungs: 2.9%; chemotherapy applications: total number: 486, average value/patient: 13.9; CA 19–9 elevated yes/no: n=13/22 (37.1%/62.9%); CEA elevated yes/no: n=15/9 (42.9%/25.7%, not evaluable: 11); higher grade toxicity (III or IV): leukocytopenia III: 14.3%, thrombocytopenia III: 2.9%, weariness III: 2.9%, diarrhea III: 5.7%, diarrhea IV: 2.9%, vomiting IV: 2.9%, pain III: 5.7%, ascites III: 5.7%, infections III: 2.9%, thromboembolia IV: 2.9%, elevated bilirubin value III: 1.7%, grade IV: 8.3%; deep leg vein thrombosis: 15%; median TTP: 5.1 months (95% CI: 2.9 - 7.2); median overall survival: 10.4 months (95% CI: 7.9 - 12.9); 6-months-/1-year-/2-year-survival rate: 65.7%/45.7%/17.1%; response rate: PR: n=5 (14.3%), SD: n=18 (51.4%), PD: n=7 (20%), not evaluable: n=5 (14.3%); tumor control (PR/SD): n=23 (65.7%); median follow-up: 10.4 months. Conclusions: Combination chemotherapy with weekly GEM as a 0.5h-inf. and 5-FU as a 24h-inf. on an out-patient basis is an effective palliative treatment schedule with solely low grade toxicity. No significant financial relationships to disclose.