Tamoxifen combined with octreotide or regular chemotherapeutic agents in treatment of primary liver cancer: a randomized controlled trial

Hepatobiliary Pancreat Dis Int. 2003 May;2(2):211-5.

Abstract

Objective: To evaluate the effect of tamoxifen (TAM) combined with a somatostatin analogue, octretide (OCT) on advanced liver cancer and whether tamoxifen combined with OCT is superior to regular chemotherapeutic agents 5-Fu and mitomycin C (MMC).

Methods: Thirty-nine patients with inoperable liver cancer were randomly subdivided into TAM+OCT group (n=24) and regular chemotherapeutic group (n=15). They received treatment for three months respectively. Blood cell count, liver function, immunologic function, blood alpha-FP was regularly measured. Liver lump and extrahepatic metastasis were examined by CT. The patients were followed up after treatment and conducted survival analysis.

Results: In the TAM+OCT group, complete response is 4 patients, partial response is 7 patients, no change is 9 patients and progressive disease is 4 patients; blood level of ALT and AST had no noticeable change, IgE and IgG increased (P<0.01), and alpha-FP lowered (P<0.05). In regular chemotherapeutic group, no change is 4 patients and progressive disease is 11 patients. There was conspicuous statistical difference in the two groups. The accumulative survival rates of 6 months, 1 year and 2 years were 95.7% vs 41.2% (P<0.01), 63.7% vs 21.1% (P<0.01), 25.4% vs 0 (P<0.01), respectively. Medium survival time was 12.8 months in TAM+OCT group and 5.5 months in chemotherapeutic group.

Conclusions: TAM+OCT excerts reliable therapeutic effect on patients with inoperable ER(+) hepatocellular cancer. It is superior to 5-Fu and MMC in increasing the survival rate, prolonging survival time, and reducing side-effects.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Antibiotics, Antineoplastic / administration & dosage
  • Antimetabolites, Antineoplastic / administration & dosage
  • Antineoplastic Agents, Hormonal / administration & dosage*
  • Antineoplastic Agents, Hormonal / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / administration & dosage
  • Carcinoma, Hepatocellular / drug therapy*
  • Carcinoma, Hepatocellular / mortality
  • Carcinoma, Hepatocellular / secondary
  • Female
  • Fluorouracil / administration & dosage
  • Humans
  • Liver / physiology
  • Liver Function Tests
  • Liver Neoplasms / drug therapy*
  • Liver Neoplasms / mortality
  • Liver Neoplasms / pathology
  • Male
  • Middle Aged
  • Mitomycin / administration & dosage
  • Octreotide / administration & dosage*
  • Octreotide / adverse effects
  • Tamoxifen / administration & dosage*
  • Tamoxifen / adverse effects
  • alpha-Fetoproteins / metabolism

Substances

  • Antibiotics, Antineoplastic
  • Antimetabolites, Antineoplastic
  • Antineoplastic Agents, Hormonal
  • alpha-Fetoproteins
  • Tamoxifen
  • Mitomycin
  • Octreotide
  • Fluorouracil