Hepatic toxicity associated with fluorouracil plus levamisole adjuvant therapy.
OBJECTIVE
To determine the frequency and nature of hepatic toxicity associated with fluorouracil (5-FU) plus levamisole adjuvant therapy.


METHODS
All patients had resection of stage II or stage III colon cancer and were randomized to receive observation only, levamisole alone, or 5-FU plus levamisole. Serial liver function studies were documented in 1,025 patients who did not develop recurrence during the year of therapy.


RESULTS
One hundred forty-nine (39.6%) of 376 patients treated with 5-FU plus levamisole showed laboratory abnormalities consistent with hepatic toxicity, compared with 16.3% of 251 patients treated with levamisole alone and 16.1% of 398 untreated controls. Most common was elevation of alkaline phosphatase, frequently accompanied by elevations of transaminase or serum bilirubin. Characteristically, these changes were mild, not associated with symptoms, and resolved when therapy was stopped. In some instances, they were associated with elevated carcinoembryonic antigen (CEA) tests or with fatty liver seen on computed tomographic (CT) scan or liver biopsy.


CONCLUSIONS
Mild and reversible hepatotoxicity is a common consequence of 5-FU plus levamisole adjuvant therapy, but this is only rarely symptomatic. However, the oncologist should be alert to this phenomenon, since the associated laboratory and imaging findings may simulate those associated with hepatic metastasis.
Moertel
C G
CG
Mayo Clinic, Rochester, MN 55905.
Fleming
T R
TR
Macdonald
J S
JS
Haller
D G
DG
Laurie
J A
JA
D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects*; D001706:Biopsy; D056486:Chemical and Drug Induced Liver Injury; D017024:Chemotherapy, Adjuvant; D003110:Colonic Neoplasms / Q000188:drug therapy; D005472:Fluorouracil / Q000009:adverse effects; D006801:Humans; D007978:Levamisole / Q000009:adverse effects; D008107:Liver Diseases / Q000473:pathology / Q000503:physiopathology; D008111:Liver Function Tests
D007978:Levamisole; D005472:Fluorouracil