Multi-centre phase II trial of Thalidomide in the treatment of unresectable hepatocellular carcinoma.
Hepatocellular carcinoma (HCC) is a hypervascular tumour, which overexpresses vascular endothelial growth factor. Thalidomide is an antiangiogenic agent with activity in refractory multiple myeloma. The purpose of this multi-centre phase II study was to evaluate the efficacy and toxicity of thalidomide in patients with advanced HCC. From February 2000 to November 2001, 37 patients with histologically proven, bi-dimensionally measurable advanced, unresectable HCC were enrolled. The starting dose of Thalidomide was 100 mg per day and escalated weekly by 100 mg to a maximum dose of 800 mg/day according to individual patient tolerance. Radiological tumour response and treatment related toxicities were prospectively assessed. Thirty-seven patients were evaluable for toxicity and 24 patients were evaluable for response. The median Thalidomide dose was 400 mg/day. There was no complete response (CR). One patient had a radiological partial response (PR) (3%; 95% confidence interval [95% CI], 0% to 8%) and six (16%) patients had stable disease for more than 6 months. Somnolence and fatigue were the most common side effects, occurring in 84% and 73% of patients respectively. Thalidomide monotherapy is tolerable and associated with modest antitumour activity in advanced HCC.
Chuah
Benjamin
B
Cancer Therapeutics Research Group, Department of Hematology-Oncology, National University Hospital, Singapore.
Lim
Robert
R
Boyer
Michael
M
Ong
Ai-Bee
AB
Wong
Seng-Weng
SW
Kong
Hwai-Loong
HL
Millward
Michael
M
Clarke
Stephen
S
Goh
Boon-Cher
BC
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D008113:Liver Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D013792:Thalidomide / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
D007166:Immunosuppressive Agents; D013792:Thalidomide