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Hepatic toxicity associated with fluorouracil plus levamisole adjuvant therapy
C G Moertel1, T R Fleming, J S Macdonald
1Mayo Clinic, Rochester, MN 55905.
Summary
Fluorouracil (5-FU) plus levamisole adjuvant therapy frequently causes mild, reversible liver damage in colon cancer patients. Oncologists should monitor for these effects, which can mimic metastasis.
Area of Science:
- Oncology
- Hepatology
- Pharmacology
Background:
- Adjuvant therapy for colon cancer often involves chemotherapy.
- Fluorouracil (5-FU) combined with levamisole is a common treatment regimen.
- Potential side effects, including liver toxicity, require thorough investigation.
Purpose of the Study:
- To assess the incidence and characteristics of liver toxicity.
- To evaluate hepatic side effects of fluorouracil (5-FU) plus levamisole adjuvant therapy.
Main Methods:
- A randomized controlled trial involving 1,025 patients with resected stage II or III colon cancer.
- Patients received observation, levamisole alone, or 5-FU plus levamisole.
- Serial liver function tests were performed during one year of therapy.
Main Results:
- Hepatotoxicity was observed in 39.6% of patients on 5-FU plus levamisole, versus 16.3% on levamisole alone and 16.1% in controls.
- Elevated alkaline phosphatase was the most common abnormality, often with increased transaminases or bilirubin.
- These changes were typically mild, asymptomatic, and resolved upon treatment cessation, but could be associated with elevated CEA or fatty liver.
Conclusions:
- Mild, reversible hepatotoxicity is a frequent outcome of 5-FU plus levamisole therapy.
- Symptomatic liver toxicity is rare, but findings may mimic hepatic metastases.
- Oncologists must be vigilant for these potential hepatic changes during adjuvant therapy.