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Dose-finding study using oxaliplatin (Ox) in combination with fixed dose gemcitabine (Gem) and radiotherapy (RT) in patients with locally advanced pancreatic or biliary tract cancer (PBCa).

14028 Background: Prognosis of inoperable PBCa is poor. Large randomized studies in pancreatic cancer showed a better survival in patients (pts) with locally advanced (LA) in comparison with metastatic disease. Data on radiochemotherapy are scarce in pts with LA disease. Therefore, we performed this multicenter, phase I study on the combination of radiotherapy and Gem/Ox. This regimen showed superior activity to Gem alone in pancreatic cancer (Louvet C et al. JCO 2005;23:3509-16.) Methods: After signed informed consent, pts with LA pancreatic cancer (n = 14) or biliary tract cancer (n=1) were included. They received two cycles of Gem/Ox1 followed by 5 weeks of RT (25 fractions of 1.8 Gy up to a total dose of 45 Gy) in combination with a weekly fixed dose of Gem (300 mg/m2 in 30') and an escalating weekly dose of Ox (levels: 40/50/60 mg/m2). NCI-CTC 2.0 was used weekly to score treatment-related toxicity in all pts.


RESULTS
Today, 15 pts. with a median age of 61 y (range: 44-74), median Karnofsky performance score 90 (range: 70-100) and M/F = 8/7 were included. Upto 60 mg/m2 Ox, no disease limiting toxicity (DLT) occured. Grade 3 toxicity included nausea (n = 1), neutropenia (n = 3) and thrombocytopenia (n = 1). This latter patient was treated with 40 mg/m2 Ox and subsequently also experienced a grade 4. One patient receiving 50 mg/m2 Ox developed a grade 4 thrombocytopenia. Most frequent grade 1/2 toxicity was nausea (n = 8, 53%), thrombocytopenia (n = 5, 33%) and diarrhea (n = 5, 30%). Fourteen out of 15 received the full course of radiotherapy. Median time to progression (TTP) is 6.7 months (95% CI: 3.7-13.5). Thirteen out of 15 pts. are still alive.


CONCLUSIONS
Combination of radiotherapy and Gemcitabin/Oxaliplatin in pts with LA pancreaticobiliairy cancer is feasible and well-tolerated. The long TTP underlines the potential activity of this regimen. As no DLT has been reached, we will use a dose of 60 mg/m2 Ox for further evaluation. [Table: see text].