A randomized phase II study of acivicin and 4'deoxydoxorubicin in patients with hepatocellular carcinoma in an Eastern Cooperative Oncology Group study

Am J Clin Oncol. 1990 Dec;13(6):510-5. doi: 10.1097/00000421-199012000-00012.

Abstract

We analyzed 56 of 75 previously untreated patients with hepatocellular carcinoma who entered on a prospectively randomized trial of acivicin versus 4'deoxydoxorubicin (esorubicin). At least one episode of severe toxicity was documented in 23% of the patients on acivicin and 45% of those on 4'deoxydoxorubicin. Two patients responded to 4'deoxydoxorubicin. One response was partial, lasting 58 weeks, and one was complete, lasting more than 4 years. The 90% confidence interval for response is 1-20%. In view of a 45% rate of severe or worse toxicity with 4'deoxydoxorubicin, this drug cannot be recommended as treatment. There were no responses on acivicin.

Publication types

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

MeSH terms

  • Antibiotics, Antineoplastic / administration & dosage
  • Antibiotics, Antineoplastic / adverse effects
  • Antibiotics, Antineoplastic / therapeutic use*
  • Carcinoma, Hepatocellular / drug therapy*
  • Carcinoma, Hepatocellular / mortality
  • Doxorubicin / administration & dosage
  • Doxorubicin / adverse effects
  • Doxorubicin / analogs & derivatives*
  • Doxorubicin / therapeutic use
  • Drug Administration Schedule
  • Female
  • Humans
  • Isoxazoles / administration & dosage
  • Isoxazoles / adverse effects
  • Isoxazoles / therapeutic use*
  • Liver Neoplasms / drug therapy*
  • Liver Neoplasms / mortality
  • Male
  • Prospective Studies
  • Survival Rate

Substances

  • Antibiotics, Antineoplastic
  • Isoxazoles
  • Doxorubicin
  • acivicin
  • esorubicin