Adjuvant chemotherapy in curative resected colon carcinoma: 5-fluorouracil/leucovorin versus high-dose 5-fluorouracil 24-h infusion/leucovorin versus high-dose 5-fluorouracil 24-h infusion.
BACKGROUND
Adjuvant postoperative treatment with 5-fluorouracil (5-FU) and leucovorin in curatively resected stage III colon cancer significantly reduces the risk of cancer recurrence and improves survival. The impact of continuous 5-FU with and without leucovorin on survival and tumor recurrence was analyzed in this study compared with the effects of bolus 5-FU/leucovorin.


METHODS
Patients with a curatively resected UICC stage III colon cancer were stratified according to T, N and G category and randomly assigned to receive one of the three adjuvant treatment schemes: 5-FU 450 mg/m2 and leucovorin 100 mg/m2 x 5 days every 4 weeks; six cycles, arm A; 24-h infusion of high-dose 5-FU/leucovorin 2,600 mg/m2 and 500 mg/m2, two cycles of six applications, arm B; 24-h infusion of high-dose 5-FU 2,600 mg/m2, two cycles of six applications, arm C.


RESULTS
One hundred and forty-five patients enrolled into this study were eligible. To date, 28 patients have died; 9 on arm A, 11 on arm B, and 8 on arm C (P was nonsignificant). After a median follow-up time of 45 months, there was no statistical difference in survival and tumor recurrence between the three treatment arms. Adjuvant treatment in all arms was generally well tolerated; only a minority of patients experienced grade 3 and 4 toxicities.


CONCLUSIONS
There is no statistical difference in efficacy and toxicity in patients receiving either high-dose 5-FU with or without leucovorin or the standard 5-FU bolus regime after a curative resection of a stage III colon cancer.
Arkenau
H T
HT
Clinic of Internal Medicine, Hospital Bremen East, Züricher Strasse 40, 28325 Bremen, Germany.
Rettig
K
K
Porschen
R
R
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage* / Q000627:therapeutic use; D017024:Chemotherapy, Adjuvant; D003082:Colectomy / Q000379:methods*; D003110:Colonic Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage* / Q000627:therapeutic use; D005500:Follow-Up Studies; D006801:Humans; D007262:Infusions, Intravenous; D002955:Leucovorin / Q000008:administration & dosage* / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011184:Postoperative Period; D012189:Retrospective Studies; D016896:Treatment Outcome
D000964:Antimetabolites, Antineoplastic; D002955:Leucovorin; D005472:Fluorouracil