Aims: The present study was conducted to evaluate the effects of irinotecan plus gemcitabine(IRINOGEM)on biliary malignancies.
Methodology: From January 2005 through January 2007, 15 consecutive patients with chemotherapy- naive, locally advanced or metastatic biliary malignancies were enrolled. The primary affected sites were the gallbladder( n=7), extrahepatic bile ducts(n=5), and intrahepatic bile ducts(n=3). All the patients received starting doses of gemcitabine at 250 mg/m /(2) and irinotecan at 25 mg/m(2) given once per 2-week cycle. In the event of progressive disease, the dosage was increased for subsequent cycles.
Results: The median number of cycles administered was 16(range, 4-24 cycles)per patient. Although one case of grade 3 neutropenia was noted, neither grade 4 toxicities nor treatment-related deaths were observed. The overall response rate was 40% and the median overall survival time was 8 months, with a 1-year cumulative survival rate of 28%.
Conclusions: IRINOGEM shows promising antitumor activity, and may be a worthwhile treatment option for locally advanced or metastatic biliary malignancies.