Intra-arterial chemotherapy for unresectable pancreatic cancer.
BACKGROUND
A phase II trial of a new intra-arterial chemotherapy regimen for unresectable pancreatic cancer (UPC).


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/m2, folinic acid 100 mg/m2, carboplatin 300 mg/m2; epirubicin 60 mg/m2.


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%; and grade 3 alopecia in 16%. One sudden death, a pre-infarction angina, and a transitory ischemic attack were observed. The only complication related to 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 assessed in a randomized study against a gemcitabine containing regimen.
Cantore
M
M
Department of Oncology C Poma Hospital, Manatova, Italy. maurizio.cantore@schering-plough.it
Pederzoli
P
P
Cornalba
G
G
Fiorentini
G
G
Guadagni
S
S
Miserocchi
L
L
Frassoldati
A
A
Ceravolo
C
C
Smerieri
F
F
Muchmore
J H
JH
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology; D002288:Adenocarcinoma, Mucinous / Q000188:drug therapy* / Q000473:pathology; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D002408:Catheters, Indwelling; D015251:Epirubicin / Q000008:administration & dosage; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D007261:Infusions, Intra-Arterial; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000188:drug therapy / Q000209:etiology; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000473:pathology; D016019:Survival Analysis; D016896:Treatment Outcome
D015251:Epirubicin; D016190:Carboplatin; D002955:Leucovorin; D005472:Fluorouracil