A phase II trial of thalidomide, α-Interferon +/–octreotide in patients with advanced hepatocellular carcinoma

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Abstract
4272 Background: Based on clinical efficacy observed in single agent phase II trials, we conducted a novel chemotherapeutic trial with a regimen consisting of thalidomide, α-interferon +/- octreotide for advanced hepatocellular carcinoma. Methods: Eligibility criteria included histologically proven unresectable or metastatic HCC, measurable disease, ECOG PS ≤ 2, age ≥ 18 yrs, may have had prior systemic or intra hepatic chemotherapy with other agents except the 3 study drugs, may have had previous surgery or regional therapy, adequate hematologic, renal and hepatic function, and informed consent. Treatment consisted of thalidomide initiated at 200 mg/day and increased up to 800 mg/day as tolerated, α-interferon 3 MU subcutaneous three times a week and octreotide 30 mg every month added for patients who had a positive octreotide scan. Results: Between December 2000 and November 2002, six patients (5 males and 1 female), median age 53.5 yrs (range 47–73 yrs) were enrolled. 50% of the patients were stage III and 50% were stage IV; 66.7% were anti-HCV positive; 83.3% had positive octreotide scans; 5/6 (83.3%) patients had not received any prior chemotherapy (systemic or intrahepatic). 1 patient received prior chemotherapy with single agent doxorubicin. Median ECOG PS was 1 and median number of cycles administered was 2 (range 1–4). Five patients were evaluable for response (1 patient withdrew before completing cycle 1). Treatment was stopped in 4 patients due to disease progression, and 1 withdrew because of toxicities. No responses were seen. Treatment was well tolerated with only 2 episodes of grade III/IV toxicity comprising neutropenia (n=1) and fatigue (n=1). Median survival after enrollment was 5 months (range 4–21 months) and the median time to progression was 2 months (range 1–4 months). Conclusion: Although demonstrating a favorable toxicity profile, combination chemotherapy with Thalidomide,α-Interferon +/- Octreotide has little activity in the treatment of advanced hepatocellular carcinoma. No significant financial relationships to disclose.

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