Chemotherapy Studies in Primary Liver Cancer: A Prospective Randomized Clinical Trial

Cancer. 1978 Nov;42(5):2149-56. doi: 10.1002/1097-0142(197811)42:5<2149::aid-cncr2820420510>3.0.co;2-5.

Abstract

One hundred and sixty-eight patients with unresectable primary liver cancer were prospectively studied by members of the Eastern Cooperative Oncology Group. These patients were randomized to receive treatment with oral 5-Fluorouracil (5FU), oral 5-Fu plus Streptozotocin, oral 5-Fu plus Methyl-CCNU or Adriamycin. The single agent treatments (oral 5-Fu and Adriamycin) were associated with less gastrointestinal toxicity than were the oral 5-Fu treatment combinations. A total of 15 partial responses were reported. Adriamycin appears to be the most active agent and responsible for 9 of the 15 responses. No response was seen in any of the 48 patients randomized to oral 5-Fu alone. The survival associated with oral 5-Fu alone was significantly shorter than the survival time associated with the remaining 3 treatment programs among both North American and South African patients. A multivariate model of survival was formulated. Covariates of prognostic significance were treatment, initial performance status and sex. South African black patients had a shorter survival time than North American black patients. Excluding oral 5-Fu from consideration, prognostic variables appeared to dominate any differences between the remaining treatments under study.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adenoma, Bile Duct / drug therapy*
  • Antineoplastic Agents / administration & dosage*
  • Antineoplastic Agents / adverse effects
  • Bone Marrow / drug effects
  • Carcinoma, Hepatocellular / drug therapy*
  • Clinical Trials as Topic
  • Doxorubicin / administration & dosage
  • Drug Therapy, Combination
  • Female
  • Fluorouracil / administration & dosage
  • Humans
  • Liver Neoplasms / drug therapy*
  • Male
  • Remission, Spontaneous
  • Semustine / administration & dosage
  • Streptozocin / administration & dosage
  • Time Factors
  • Vomiting / chemically induced

Substances

  • Antineoplastic Agents
  • Semustine
  • Streptozocin
  • Doxorubicin
  • Fluorouracil