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Effects of the combined treatment with thalidomide, megestrol and interleukine-2 in cirrhotic patients with advanced hepatocellular carcinoma. A pilot study.

AbstractBACKGROUND:
Thalidomide, an anti-angiogenic agent, does not have a good therapeutic effect for advanced hepatocellular carcinoma when used alone. Megestrol and interleukin-2 have been proposed as a palliative treatment for hepatocellular carcinoma. AIMS.: We assessed the effectiveness/safety of a combined therapy with thalidomide+megestrol+interleukin-2 in cirrhotic patients with advanced hepatocellular carcinoma.
PATIENTS AND METHODS:
Nine cirrhotic patients with advanced hepatocellular carcinoma received oral megestrol (160 mg/day) and thalidomide (from 50 mg/day to the maximal tolerated dose). Four patients also received subcutaneous interleukin-2 (1 million U/day for 21 days/month).
RESULTS:
The maximal tolerated dose of thalidomide was 150 mg/day. All patients complained of sedation and other neurological or digestive adverse effects. In all but one patient the adverse effects disappeared after thalidomide withdrawal or dose reduction. Interleukin-2 administration caused a flu-like syndrome and a reaction at the injection site. During treatment, alpha-fetoprotein increased in six patients, remained stable in two and decreased in one. Eight patients showed tumour progression and one had a stable disease. Eight patients died. The median survival was 9.9 (range 2.6-18.6) months.
CONCLUSION:
In cirrhotic patients, the combined treatment with thalidomide+megestrol (+/-interleukin-2) does not control hepatocellular carcinoma growth, possibly due to the low tolerance to thalidomide and interleukin-2 preventing the use of appropriate dosages.
AuthorsF Mirici Cappa, M C Cantarini, G Magini, A Zambruni, C Bendini, V Santi, M Bernardi, F Trevisani
JournalDigestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver (Dig Liver Dis) Vol. 37 Issue 4 Pg. 254-9 (Apr 2005) ISSN: 1590-8658 [Print] Netherlands
PMID15788209 (Publication Type: Clinical Trial, Journal Article)
Chemical References
  • Antineoplastic Agents, Hormonal
  • Immunosuppressive Agents
  • Interleukin-2
  • alpha-Fetoproteins
  • Thalidomide
  • Megestrol
Topics
  • Aged
  • Antineoplastic Agents, Hormonal (administration & dosage, adverse effects)
  • Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
  • Carcinoma, Hepatocellular (complications, drug therapy, mortality)
  • Diarrhea (chemically induced)
  • Dose-Response Relationship, Drug
  • Female
  • Humans
  • Immunosuppressive Agents (administration & dosage, adverse effects)
  • Interleukin-2 (administration & dosage, adverse effects)
  • Liver Cirrhosis (complications, drug therapy)
  • Liver Neoplasms (complications, drug therapy, mortality)
  • Male
  • Megestrol (administration & dosage, adverse effects)
  • Middle Aged
  • Neoplasm Staging
  • Pilot Projects
  • Survival Analysis
  • Survival Rate
  • Thalidomide (administration & dosage, adverse effects)
  • Treatment Outcome
  • Tremor (chemically induced)
  • alpha-Fetoproteins (metabolism)

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