Efficacy, safety, and potential biomarkers of thalidomide plus metronomic chemotherapy for advanced hepatocellular carcinoma

Yu Yun Shao, Zhong Zhe Lin, Chiun Hsu, Kuan Der Lee, Chi Huang Hsiao, Yen Shen Lu, Chien Chung Huang, Yin Chun Shen, Chih Hung Hsu, Ann Lii Cheng

Research output: Contribution to journalArticlepeer-review

26 Citations (Scopus)


Objectives: Thalidomide has been shown to have antitumor activity in some patients with advanced hepatocellular carcinoma (HCC). We initiated a phase II study to determine the safety and efficacy of adding metronomic chemotherapy to thalidomide as first-line therapy. Methods: This open- labeled, single-arm, multicentered, investigator-initiated study enrolled patients with treatment-naïve advanced HCC not amenable to locoregional therapies. Treatment included oral thalidomide (100 mg twice daily) and tegafur/uracil [125 mg/m2 (based on tegafur) twice daily]. Tumor assessment was performed according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.0. Pretreatment plasma levels of angiogenesis factors were correlated with patient outcomes. Results: Forty-three patients were included. Sixteen (37%) patients had a Cancer of the Liver Italian Program (CLIP) score of 4, and 31 (72%) patients had chronic hepatitis B virus infection. The objective response rate was 9%, and the disease stabilization rate was 33%. The median progression-free survival was 1.9 months (95% CI 1.7-2.1 months), and the median OS was 4.6 months (95% CI 2.3-6.9 months). Treatment was generally tolerable. High baseline plasma levels of interleukin (IL)-6 and IL-8 were adversely correlated with patient survivals. Conclusions: The combination of thalidomide and tegafur/uracil was safe and demonstrated modest activity in patients with advanced HCC.

Original languageEnglish
Pages (from-to)59-66
Number of pages8
Issue number1
Publication statusPublished - Feb 2012
Externally publishedYes


  • Hepatocellular carcinoma
  • Interleukin-6
  • Interleukin-8
  • Metronomic chemotherapy
  • Thalidomide

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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