Phase II study of cisplatin and 120-hour continuous infusion of 5-fluorouracil in patients with advanced pancreatic adenocarcinoma.
BACKGROUND
Advanced pancreatic carcinoma (APC) is a rapidly fatal disease and an active chemotherapy with palliative effects and impact on patient survival is needed. 5 fluorouracil (5-FU) combined with cisplatin (CDDP) has a recognized synergistic activity, but its activity in APC has never been well established.


METHODS
Forty eligible patients (pts) with measurable APC were treated in a phase II trial with 5-FU 1000 mg/m2/day from day 1 to day 5 by continuous intravenous infusion and CDDP 100 mg/m2 on day 2. Eighty percent of the pts (36/40) had metastatic disease, 32.5% (13/40) were previously treated and 65% (26/40) had performance states of 2 or 3.


RESULTS
Of 38 evaluable pts, one had a complete response and 9 achieved partial responses; the overall response rate (RR) was 26.5% (95% CI: 12% to 40%). The median duration of responses was 10 months (range 4-18). The RR in non-pretreated pts was 32% A palliative effect was seen in 45% of pts (17/38). The median survival was 7 months and 12 pts (29%) were alive at 1 year. Leukopenia was the most important toxicity; 11 pts (27%) had a grade 4 leukopenia and 3 had neutropenic fever.


CONCLUSIONS
The combination of CDDP and 5-FU in continuous infusion seems an active and well tolerated treatment in APC and will be compared to standard therapy in a multicentric randomized trial.
Department of Medicine, Institute Gustave Roussy, Villejuif, France.
P
P
Rougier
J J
JJ
Zarba
M
M
Ducreux
M
M
Basile
J P
JP
Pignon
M
M
Mahjoubi
M
M
Benahmed
J P
JP
Droz
E
E
Cvitkovic
J P
JP
Armand
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000401:mortality; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage; D004334:Drug Administration Schedule; D004357:Drug Synergism; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D005500:Follow-Up Studies; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000401:mortality; D015996:Survival Rate
D002945:Cisplatin; D005472:Fluorouracil