552 Intra-arterial chemotherapy for locally advanced carcinoma of the pancreas (LAPC)

Background The very limited efficacy of current chemotherapeutic strategies in LAPC, the pattern of metastatic spread largely confined to the upper abdominal organs within the arterial supply of celiac axis induced us to design this phase II study of locoregional intra-arterial chemotherapy. Purpose The aim of the present study was to evaluate the feasibility, the toxicity, the response rate and the real impact on survival of a new combination of drugs administered intra-arterially in the treatment of LAPC. Patients and methods From January 1994 to March 1995, twenty-five consecutive patients with LAPC were given 2 intra-arterial cycles of chemotherapy through a catheter in celiac axis introduced via the femoral artery, on days 1 and 22. The schedule was FLEC: 5 fluoruracil (5FU) 1000 mg/sqm; leucoverin (LV) 100 mg/sqm, epirubicin (EPI) 60 mg/sqm and carboplatin (CP) 300 mg/sqm: each drug was infused over a period of 10 minutes and only one day of hospitalization was necessary for each cycle. After 2 cycles when we obtain a partial response (PR) or a stable disease (SD), other 2 cycles were planned. Results A total of 74 courses of chemotherapy were administered with a mean of 2.9 for each patient (1–5). 23 patients are evaluable for response: 10/23 patients had a PR (43%) evaluated by ct-scan, 14/23 had a decrease of Ca 19-9 (61%),14/23 had an improvement in quality of life (61%). Grade 3/4 hematological toxicity was observed in 5/23 (22%); grade 2/3 gastrointestinal toxicity in 2/23 (9%); alopecia in 2/23 (9%). One sudden death was observed in a patient on day 23 after the third cycle. No complications related to angiographic procedure was noted. At a median follow up of 4 months (1–13), the median survival is 5.6 months and 1-year survival rate is 51% and 9% for responders and non responders respectively. Conclusions This study showed that the FLBC combination given through a celiac axis infusion is well tolerated and active and may become an important strategy both in a palliative and in a preoperative setting in patients with pancreatic carcinoma.