A pilot study of adjuvant intraperitoneal 5-fluorouracil using 4% icodextrin as a novel carrier solution.
OBJECTIVE
This pilot study utilised the sustained intraperitoneal (i.p.) dwell properties of an iso-osmotic solution of 4% icodextrin to investigate the tolerability, toxicity and feasibility of home-based i.p. 5FU adjuvant chemotherapy following resective surgery for colorectal cancer.


METHODS
Twenty eligible patients (Dukes' stage B and C with potentially curative resection) underwent perioperative Tenckhoff catheter placement. Ten (6 male, 4 female, aged 46-85; mean 67.5 years) received 5FU chemotherapy. After initial flushing and gradual increase in volumes of 4% icodextrin alone, patients received home-based i.p. 5FU (150-300 mg/m(2)/day given as equal doses at 12-hourly intervals) for 14 days, with a 14-day recovery period, for a maximum of 6 courses. Two incurable patients, treated on compassionate grounds, provided further safety data.


RESULTS
Nine of the 10 patients became proficient in self-treatment with 5FU and two completed 6 courses. Frequent abdominal pain was the main dose-limiting toxicity of 5FU, causing withdrawal of three patients after a high (300 mg/m(2)/day) first course and one following a third course at lower doses. I.p. 5FU concentrations (mean>30000 ngml(-1)) were 1000 fold higher than systemic venous levels. Bacterial peritonitis led to two withdrawals but was not a frequent event (microbiologically confirmed incidence of 1 per 27 catheter-months).


CONCLUSIONS
Home-based i.p. adjuvant chemotherapy is a feasible treatment option in patients with surgically resected colorectal carcinoma.
Hosie
K B
KB
Department of Surgery, Northern General Hospital, Sheffield S5 7AU, UK.
Kerr
D J
DJ
Gilbert
J A
JA
Downes
M
M
Lakin
G
G
Pemberton
G
G
Timms
K
K
Young
A
A
Stanley
A
A
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000601:surgery; D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage* / Q000493:pharmacokinetics; D017024:Chemotherapy, Adjuvant; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000601:surgery; D015314:Dialysis Solutions / Q000008:administration & dosage*; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage* / Q000493:pharmacokinetics; D005936:Glucans / Q000008:administration & dosage; D005947:Glucose / Q000008:administration & dosage; D006699:Home Care Services; D006801:Humans; D000077607:Icodextrin; D007263:Infusions, Parenteral; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D016896:Treatment Outcome
D000964:Antimetabolites, Antineoplastic; D015314:Dialysis Solutions; D005936:Glucans; D000077607:Icodextrin; D005947:Glucose; D005472:Fluorouracil