Abstract
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 (1 ND). A total of 130 cycles (group A: 111; group B: 19) were delivered (median = 3 [1–13]). Hematological grade 3–4 toxicities by pt (group A/group B) consisted in neutropenia (48% / 17%) and febrile neutropenia (13% / 0%), anemia (22% / 33%). Non hematological toxicities by pt were: vomiting (8% / 0%), diarrhea (22% / 0%), hepatic cytolysis (4% / 0%) asthenia (17% / 0%). One 1 MR (group A), 13 SD (group A:10 / group B:3) and 11 PD (group A:9 / group B:2) were observed among the 25 evaluable pts for efficacy. Overall survival was 7.4 in months [95%CI 3.9–12.0]. Median time to progression was 3.7 months [95%CI 2.1–4.0]. Tumor growth control lasted 4.0 months [95%CI 3.8–7.1] Conclusions: In pts with unresectable HCC, CPT-11 adjusted to bilirubinemia is feasible in pts with liver dysfunction and achieved 56% disease control in poor prognosis patients. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Laboratoire Aventis Laboratoire Aventis Laboratoire Aventis
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