Levamisole as adjuvant to chemotherapy of ovarian cancer. Results of a randomized trial and 4-year follow-up

Cancer. 1984 Sep 15;54(6):986-90. doi: 10.1002/1097-0142(19840915)54:6<986::aid-cncr2820540607>3.0.co;2-g.

Abstract

The results of a randomized trial, stratified according to age and stage of disease, in 140 patients with ovarian cancer are presented. The drug, levamisole, or a placebo was given as adjuvant to cytotoxic chemotherapy for 12 months after maximal surgical reduction of tumor. Because of severe side effects, levamisole treatment was discontinued in 8 of 69 patients (marked neutropenia in 5, severe skin rashes in 3). There were no significant differences in the survival curve and mean duration of survival between levamisole-treated and placebo-treated groups during the 4 years of follow-up, except for patients with Stage II disease. Among these latter patients, the survival rate became progressively much lower in the levamisole-treated group and the difference reached statistical significance after the second year of follow-up (P less than 0.01). In view of the inconclusive evidence that levamisole provides a beneficial effect (in fact, there is concern of a deleterious effect) and the serious side effects, the drug should not be used in patients with ovarian cancer.

Publication types

  • Clinical Trial

MeSH terms

  • Adjuvants, Immunologic / therapeutic use*
  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use
  • Clinical Trials as Topic
  • Female
  • Follow-Up Studies
  • Humans
  • Levamisole / administration & dosage*
  • Levamisole / adverse effects
  • Melphalan / therapeutic use
  • Middle Aged
  • Neutropenia / chemically induced
  • Ovarian Neoplasms / drug therapy*
  • Ovarian Neoplasms / mortality
  • Ovarian Neoplasms / surgery
  • Placebos
  • Random Allocation

Substances

  • Adjuvants, Immunologic
  • Placebos
  • Levamisole
  • Melphalan