Palliative systemic combination chemotherapy with gemcitabine (GEM) and weekly 24h-infusion of high-dose 5-fluorouracil (5- FU) in patients with metastatic pancreatic cancer (UICC stage IV)

Abstract

15644 Background: Due to the late diagnosis of pancreatic carcinomas in an advanced tumor stage, the application of palliative chemotherapy is frequently left as the only indicated treatment option. A meta-analysis by Sultana et al. (J Clin Oncol 2007) and Heinemann et al. (Ann Oncol 2007) describes a survival advantage of a GEM-based combination therapy compared with the standard single-agent GEM. The aim of this analysis 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 pancreatic cancer. Methods: Retrospective evaluation of 60 pts. based on the tumor registry data of the Dept. of Internal Medicine 1, evaluation period: 4/1998 - 8/2007, treatment schedule: 1.000 mg/m2 of GEM as a 0,5h-inf. combined with 2.000 mg/m2 of 5-FU as a 24h-inf. via port catheter on d 1, 8, 15 qd 22. Results: Median age: 64 years; m/f: n=40/20; ECOG 0/1/2/: n=21/26/13; histology: adenocarcinoma n=59, adenosquamous carcinoma n=1; G1/G2/G3/G4/not evaluable (n.e.): n=4/27/26/1/2; localisation: pancreatic (panc.) head n=37, panc. body n=6, panc. tail n=13, panc. body/tail junction n=4; metastases: liver: 75%, lymph. nodes: 57%, peritoneum:17%, lungs:12%; chemoth. appl.: total number: 785, average value/patient: 13; CA 19–9 elevated (el.) yes/no: n=43/13 (77%/23%, n.e.:6); CEA el. yes/no: n=21/27 (44%/56%, n.e.:12); higher grade toxicity (III or IV): leukocytopenia III: 13,3%, IV: 1,3%; thrombocytopenia III: 5%; anemia III: 8,3%, IV: 1,7%; fatigue III: 3,3%; diarrhea III: 5%; nausea III: 5%; vomiting III: 1,7%; fever III: 1,7%; infections III: 3,3%; hyponatremia IV: 3,3%; el. bilirubin value III: 1,7%, IV: 8,3%; deep leg vein thrombosis: 15%; median TTP: 4 mo.; median overall survival (ms): 7,3 mo. (95% CI 5,4 - 9,1); 1-year-survival rate: 28,3%; response: CR: 1,7%, PR: 5%, SD: 52%, PD: 30%, n.e.: 11,7%; tumor control (CR/PR/SD): 58%; median follow-up: 7,6 mo. (0,7- 60 mo.). Conclusion: In accordance with the two mentioned meta- analyses our results demonstrate that a GEM-based combination therapy with weekly high-dose 5-FU (ms: 7,3 mo.) is superior to single-agent GEM in terms of median survival. No significant financial relationships to disclose.