Hintergrund: Mit einer medianen Überlebenszeit von 5,6 Monaten (Burris, 1997) sind die Ergebnisse der Monotherapie mit Gemcitabin (Gem) weiterhin unbefriedigend. Präklinisch und klinisch nachgewiesene Synergismen zwischen Gem/5-FU, Gem und Oxaliplatin (Ox) sowie Ox /5-FU bei gleichzeitig nicht-überlappendem Toxizitätsprofil bilden die Rationale für den Einsatz dieser Kombinationstherapie.

Gemcitabine, oxaliplatin and 5-fluorouracil (5-FU) are active in biliary tract cancer and have a potentially synergistic mode of action and non-overlapping toxicity. The objective of these trials was to determine response, survival and toxicity separately in patients with bile duct cancer (BDC) and gallbladder cancer (GBC) treated with gemcitabine/oxaliplatin/5-FU chemotherapy. Eligible patients with histologically proven, advanced or metastatic BDC (n=37) or GBC (n=35) were treated with gemcitabine (900 mg m−2 over 30 min), oxaliplatin (65 mg m−2) and 5-FU (1500 mg m−2 over 24 h) on days 1 and 8 of a 21-day cycle. Tumour response was the primary outcome measure. Response rates were 19% (95% CI: 6–32%) and 23% (95% CI: 9–37%) for BDC and GBC, respectively. Median survivals were 10.0 months (95% CI: 8.6–12.4) and 9.9 months (95% CI: 7.5–12.2) for BDC and GBC, respectively, and 1- and 2-year survival rates were 40 and 23% in BDC and 34 and 6% in GBC (intention-to-treat analysis). Major grade III and IV adverse events were neutropenia, thrombocytopenia, elevated bilirubin and anorexia. Triple-drug chemotherapy achieves comparable results for response and survival to previously reported regimens, but with more toxicity.