REVERSIBLE HEPATIC STEATOSIS IN PATIENTS TREATED WITH INTERFERON ALFA-2A AND 5-FLUOROURACIL

Background. Thirty previously untreated patients with metastatic color ectal carcinoma were randomized as part of two multicenter Phase III t rials. Twenty-two patients were randomized to receive either 5-fluorou racil (5-FU)/interferon alfa-2A (IFN-alpha) or 5-FU/leucovorin (11 pat ients in each arm). Eight patients were randomized to receive 5-FU/IFN -alpha or 5-FU alone (4 patients in each arm). Methods. Twenty-three p atients (13 patients treated with 5-FU/IFN-alpha and 10 patients treat ed with 5-FU/leucovorin or 5-FU alone) were evaluated regularly for re sponse by computed tomography (CT) scans of the abdomen when treatment began and then every 6-8 weeks. Results. Incidentally, four patients developed hepatic steatosis during treatment with IFN-alpha and 5-FU. The diagnosis was based on a decreased CT value of the liver parenchym a by repeated CT scans of the abdomen during treatment, and this diagn osis was verified histologically by liver biopsy. There was no relatio nship to cumulative IFN-alpha or 5-FU dose. Based on posttreatment CT scans, the liver parenchyma changes were reversible after therapy was stopped, and there were no significant clinical sequelae. No patients treated with 5-FU/leucovorin or 5-FU alone experienced a decreased CT value of the liver parenchyma. Conclusion. Hepatic steatosis was been observed in approximately 30% of patients treated with IFN-alpha and 5 -FU. The hepatic changes were fully reversible after the treatment was stopped. Recognition of this condition is important to prevent a pati ent from being labeled as having progressive hepatic metastases.