ISSN:
1569-8041
Keywords:
adjuvant treatment
;
Dukes' C colon cancer
;
5-fluorouracil
;
leucovorin
;
levamisole
Source:
Springer Online Journal Archives 1860-2000
Topics:
Medicine
Notes:
Abstract Purpose:To assess the effect of the addition of leucovorin to thecombination of 5-fluorouracil (5-FU)–levamisole on recurrence risk andoverall survival in patients after a resection with curative intent of aDukes' C colon cancer. Patients and methods:Five hundred patients with Dukes' C coloncancer were randomly assigned to adjuvant treatment for one year with5-fluorouracil (450 mg/m2 i.v. weekly) and levamisole (150 mg p.o.every two weeks), the C-group or with leucovorin (20 mg/m2 i.v.),5-fluorouracil and levamisole, the L-group. The median follow-up for patientsstill alive is 36 months. Four patients were ineligible because of advanceddisease at the time of randomisation. Results:Sixty percent of the patients have completed all coursesof chemotherapy. Of the remaining 40% of the patients who did notcomplete one-year treatment with chemotherapy, 46% discontinued becauseof toxic and/or emotional reasons. They were equally divided over bothtreatment arms. The addition of leucovorin increased toxicity (especiallymucositis and conjunctivitis) without a significant increase in treatmentwithdrawal. Five-year disease-free interval (C-group: 49%, L-group:46%; log-rank test, P = 0.86) and overall survival (C-group:55%, L-group: 59%, log-rank test: P = 0.96) were verysimilar in both treatment arms. Conclusions:The addition of low dose leucovorin to thecombination of 5-fluorouracil and levamisole in a 12-month adjuvant therapyfor curatively resected Dukes' C colon cancer patients does not improvedisease-free interval nor overall survival. The addition of leucovorin to thecombination of 5-FU–levamisole increases toxicity. Thereforeleucovorin–5-FU–levamisole is not recommended in a 12 monthsadjuvant regime of Dukes' C colon cancer.
Type of Medium:
Electronic Resource
URL:
http://dx.doi.org/10.1023/A:1008351312879
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