Thalidomide shows efficacy as adjuvant therapy for hepatocellular carcinoma patients

(Press-News.org) Berlin, Germany, Saturday 02 April 2011: Thalidomide has shown potential to be used as the first adjuvant therapy for hepatocellular carcinoma (HCC), according to data presented at the International Liver CongressTM 2011.1

A new study found thalidomide gave HCC patients who'd undergone grossly curative resection surgical removal of the cancerous part of the liver double the two-year disease free survival rate (65%) compared to placebo (33%).

However, the study did find that the two-year overall survival rate was comparable between patients treated with thalidomide and patients given placebo – 84.2% and 85.7% respectively.

Daniele Prati, EASL's Scientific Committee Member and Press Committee Chairman, commented: "Current options for adjuvant therapy in HCC are very limited and clinical trial results have been disappointing. Thalidomide has already been proven to work well in a number of other areas and this study shows it could potentially benefit HCC patients who are particularly difficult to treat. Overall, it is important to continue research in evaluating adjuvant therapy in HCC."

Surgery is the main form of treatment for HCC, but is only possible for a small proportion of those afflicted. Even after curative resection, recurrence is common and is the main cause of death. Adjuvant therapy that is, chemotherapy after surgery – is thus attempted to try to improve outcomes.2

The study is promising because there is currently no adjuvant therapy for HCC patients following curative resection.

Indeed, the most up-to-date Cochrane Review of adjuvant therapies for HCC (conducted prior to this thalidomide study) found insufficient evidence to show that previously investigated adjuvant therapies increased survival for HCC, and only limited evidence to suggest that adjuvant therapy was useful in disease-free survival.2

In the double-blind, placebo controlled, randomized, comparative phase-II study, 42 patients were given 200mg per day oral dose of thalidomide (Arm A, 21 patients) or 200mg per day oral dose of placebo (Arm B, 21 patients). Patients started treatment within 6 weeks of complete tumor resection and carried on treatment for 12 months, or until they encountered disease recurrence, intolerably toxicity, or withdrew consent. Overall, thalidomide showed a good tolerability profile.

Thalidomide is currently approved by the European Medicines Agency (EMA) and Food and Drug Administration (FDA) in the US for the treatment of multiple myeloma (a cancer of the bone marrow).3,4

### Notes to Editors

About EASL EASL is the leading European scientific society involved in promoting research and education in hepatology. EASL attracts the foremost hepatology experts and has an impressive track record in promoting research in liver disease, supporting wider education and promoting changes in European liver policy.

EASL's main focus on education and research is delivered through numerous events and initiatives, including: The International Liver CongressTM which is the main scientific and professional event in hepatology worldwide Meetings including Monothematic and Special conferences, Post Graduate courses and other endorsed meetings that take place throughout the year Clinical and Basic Schools of Hepatology, a series of events covering different aspects in the field of hepatology Journal of Hepatology published monthly Participation in a number of policy initiatives at European level

About The International Liver CongressTM 2011 The International Liver Congress™ 2011, the 46th annual meeting of the European Association for the study of the Liver, is being held at the Internationales Congress Centrum, Berlin, Germany from March 30 – April 3, 2011. The congress annually attracts over 7,500 clinicians and scientists from around the world and provides an opportunity to hear the latest research, perspectives and treatments of liver disease from principal experts in the field.

References 1. Ho M-C et al. A randomized pilot phase II study of thalidomide as adjuvant therapy in patient with high recurrence risk hepatocellular carcinoma. Abstract presented at The International Liver CongressTM 2011. http://www1.easl.eu/easl2011/program/Orals/342.htm

2. Samuel M et al. Neoadjuvant and adjuvant therapy for surgical resection of hepatocellular carcinoma. Cochrane Database of Systematic Reviews 2009, Issue 1. Art. No.: CD001199. DOI: 10.1002/14651858.CD001199.pub2.

3. European Medicines Agency. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000823/human_med_001090.jsp&murl=menus/medicines/medicines.jsp&mid=WC0b01ac058001d124&jsenabled=true. Accessed 09.03.2011.

4. EU-orphan. http://www.euorphan.com:81/active_substance/Default.aspx?LANG=UK&AGENCY=A&STATUS=A&menu=3&alfa=T&alfa1=U. Accessed 09.03.2011