Objective: To evaluate the safety and efficiency of epirubicin in the treatment of malignant obstructive jaundice (MOJ).
Methods: Thirty-nine patients with diagnosis of MOJ, whose serum total bilirubin (TB) had not dropped to normal level after stent placement or percutaneous transhepatic biliary drainage, received trans-arterial chemoembolization (TACE). During TACE, epirubicin emulsion containing pharmorubicin at dose of 30 mg/m(2) was used. The toxicity and hepatic injury was observed according to WHO anticancer drug toxicity criterion and Child-Pugh classification criterion, respectively. The time of jaundice recurrence and survival were also observed during follow-up.
Results: Median total serum bilirubin in 39 patients was 72.7 micromol/L (range: 52.1 - 91.4 micromol/L) before TACE. The dose of pharmorubicin was 40 - 60 mg with a median of 55.0 mg and the amount of lipiodol was 2 - 25 ml. Decrease in white blood cell count was observed: grade I in 41.0% of patients, grade II in 35.9% and grade III - IV in 15.4%. Grade III - IV nausea and vomiting developed in 100% of the patients. Hepatic injury became aggravated in 8 from A to B class patients, in one from A to C class, and in 3 from B to C class according to Child-Pugh classification criterion. No cardiac toxicity was observed in this series. The median survival time was 6.0 months with a range of 2 to 72 months. Jaundice recurred in 19 patients (48.7%) with a medium jaundice recurrence time of 9.0 months (range: 2 - 20 months).
Conclusion: Epirubicin-lipiodol emulsion at a dose of 30 mg/m(2) is safe and efficient in the management of patients with malignant obstructive jaundice with total serum bilirubin between 51 and 100 micromol/L after biliary drainage.