BACKGROUND: The hypervascular nature of hepatocellular carcinoma (HCC) is well characterized. Recent data have suggested that thalidomide possesses antiangiogenic and immunomodulatory activity. Therefore, the authors initiated a study to assess the efficacy and toxicity of thalidomide in patients with advanced HCC as primary and secondary endpoints, respectively. METHODS: Inclusion criteria were unresectable HCC with bidimentionally measurable disease, age > or = 18 years, Eastern Cooperative Oncology Group performance status < or = 2, and adequate organ function. Thalidomide was administered at a starting dose of 200 mg per day in a 100-mg-per-week dose escalation regimen, up to the maximum tolerated dose or to 800 mg per day. Toxicity was monitored according to the National Cancer Institute Common Toxicity Criteria. RESULTS: Twenty-six of 27 patients were eligible and assessable for toxicity and response. A median daily dose of 300 mg was achieved. One patient experienced near-complete recovery of alpha-fetoprotein levels and a partial radiographic response on computed tomography. Two patients had stable disease during the 16-week study period. The median duration of progression-free survival was 42 days. The overall median survival was 123 days. Fatigue and somnolence were the most common side effects, occurring in 81% and 62% of patients, respectively. No Grade 4 hematologic toxicity was observed. Three patients experienced Grade 4 hepatic toxicity (namely, hyperbilirubinemia). CONCLUSIONS: With gradual dose escalation, thalidomide was tolerated in most patients with advanced HCC. However, treatment with thalidomide alone was associated with only a modest response in the treatment of HCC.
BACKGROUND: The hypervascular nature of hepatocellular carcinoma (HCC) is well characterized. Recent data have suggested that thalidomide possesses antiangiogenic and immunomodulatory activity. Therefore, the authors initiated a study to assess the efficacy and toxicity of thalidomide in patients with advanced HCC as primary and secondary endpoints, respectively. METHODS: Inclusion criteria were unresectable HCC with bidimentionally measurable disease, age > or = 18 years, Eastern Cooperative Oncology Group performance status < or = 2, and adequate organ function. Thalidomide was administered at a starting dose of 200 mg per day in a 100-mg-per-week dose escalation regimen, up to the maximum tolerated dose or to 800 mg per day. Toxicity was monitored according to the National Cancer Institute Common Toxicity Criteria. RESULTS: Twenty-six of 27 patients were eligible and assessable for toxicity and response. A median daily dose of 300 mg was achieved. One patient experienced near-complete recovery of alpha-fetoprotein levels and a partial radiographic response on computed tomography. Two patients had stable disease during the 16-week study period. The median duration of progression-free survival was 42 days. The overall median survival was 123 days. Fatigue and somnolence were the most common side effects, occurring in 81% and 62% of patients, respectively. No Grade 4 hematologic toxicity was observed. Three patients experienced Grade 4 hepatic toxicity (namely, hyperbilirubinemia). CONCLUSIONS: With gradual dose escalation, thalidomide was tolerated in most patients with advanced HCC. However, treatment with thalidomide alone was associated with only a modest response in the treatment of HCC.
Authors: Jens Walldorf; Andrea Tannapfel; Hans Jürgen Holzhausen; Christian Wittekind; Thomas Seufferlein; Utz Settmacher; Wolfgang E Fleig; Matthias M Dollinger Journal: BMJ Case Rep Date: 2009-11-29
Authors: Masao Omata; Laurentius A Lesmana; Ryosuke Tateishi; Pei-Jer Chen; Shi-Ming Lin; Haruhiko Yoshida; Masatoshi Kudo; Jeong Min Lee; Byung Ihn Choi; Ronnie T P Poon; Shuichiro Shiina; Ann Lii Cheng; Ji-Dong Jia; Shuntaro Obi; Kwang Hyub Han; Wasim Jafri; Pierce Chow; Seng Gee Lim; Yogesh K Chawla; Unggul Budihusodo; Rino A Gani; C Rinaldi Lesmana; Terawan Agus Putranto; Yun Fan Liaw; Shiv Kumar Sarin Journal: Hepatol Int Date: 2010-03-18 Impact factor: 6.047
Authors: Niraj J Gusani; Yixing Jiang; Eric T Kimchi; Kevin F Staveley-O'Carroll; Hua Cheng; Jaffer A Ajani Journal: Drugs Date: 2009 Impact factor: 9.546
Authors: R Biffi; F Orsi; M G Zampino; A Chiappa; N Fazio; F De Braud; G Bonomo; L Monfardini; P D Vigna; F Luca; L Bodei; M Bartolomei; G Catalano; M C Leonardi; M Ferrari; B Andreoni; A Goldhirsch; G Paganelli; R Orecchia Journal: Ecancermedicalscience Date: 2008-05-02