Background: A phase II trial of a new intra-arterial chemotherapy regimen f
or unresectable pancreatic cancer (UPC).
Patients and methods: Ninety-six patients with UPC were treated with intra-
arterial chemotherapy at three-weekly intervals. The schedule used was FLEC
: 5-fluorouracil 1000 mg/m(2), folinic acid 100 mg/m(2), carboplatin 300 mg
/m(2); epirubicin 60 mg/m(2).
Results: The overall response rates by CT-scan evaluation were: 15% partial
response (PR), 44% stable disease (SD), 17% progressive disease (PD). The
overall median survival was 9.9 months, and 10.6 and 6.8 for UICC stage III
and IV, respectively. Pain reduction occurred in 42% of patients. A weight
gain > 7% from baseline occurred in 8% of patients. A total of 341 courses
of FLEC were administered. Grade 3-4 hematological toxicity was seen in 25
% of patients; ematemesis in 4%; grade 3 gastrointestinal toxicity in 3%; a
nd grade 3 alopecia in 16%. One sudden death, a pre-infarction angina, and
a transitory ischemic attack were observed. The only complication related t
o the angiographic procedure was an intimal dissection of the iliac artery.
Conclusions: The intra-arterial FLEC regimen was well tolerated and active.
It requires only one day of hospitalization. Efficacy could only be assess
ed in a randomized study against a gemcitabine containing regimen.