Final results of a multicenter phase II study of irinotecan (CPT-11) in patients (pts) with advanced hepatocellular carcinoma (HCC)

4180 Background: The objective of this study was to determine the efficacy and safety of CPT-11 as a single agent in pts with HCC. Because chronic liver dysfunction is frequently observed in these pts, CPT-11 dose was adjusted to bilirubin, according to the results of our previous phase I study on CPT-11 in pts with hyperbilirubinemia. Methods: The primary endpoint was the response rate of CPT-11 in pts with HCC not candidates for surgical resection or percutaneous destruction. Pts with multifocal HCC, no prior systemic chemotherapy, PS ≤ 2, adequate renal and bone marrow function, and bilirubin ≤ 3xUNL, were enrolled. Pts in group A (bilirubin ≤1.5xUNL) and group B (bilirubin 1.5 to 3.0xUNL) received i.v. CPT-11 at 350 mg/m2, and 200 mg/m2 respectively, over 30 to 90 min, q3w. Tumor response was evaluated by CT scan or RMN coupled with α–foetoprotein dosage every 3 courses. Results: 29 pts (23 in group A, 6 in group B) were included: median age = 59 [24–76], sex ratio (M/F) = 24 / 5; PS 0/1/2 = 14/12/2 (...