Randomized controlled study of the effect of adjuvant immunotherapy with Picibanil on 51 malignant gliomas

Surg Neurol. 1987 Mar;27(3):259-63. doi: 10.1016/0090-3019(87)90039-5.

Abstract

During the period from January 1981 to December 1983, two groups of a total of 51 patients (31 malignant astrocytomas, 17 glioblastomas, and 3 others) were treated with radioimmunochemotherapy using nimustine hydrochloride (ACNU) plus Picibanil (OK-432) (group A) and radiochemotherapy with ACNU only (group B) in a randomized controlled study. Group A consisted of 24 patients and group B of 27 patients. The differences in the background of the two groups were not statistically significant. Survival curves of both groups were shown by the Kaplan-Meier method. The postoperative survival rate at 1 year and 3 years was 70% and 30%, respectively, equal in both groups, and the differences between groups A and B were not statistically significant by the Cox-Mantel test. The side effects seen in group B were most prominent in the bone marrow, and severe leukopenia occurred. However, in group A leukopenia was suppressed after 2 months. Immunologic parameters, such as the purified protein derivative skin reaction test, did not change, but the streptococcus pyogenes Su-strain polysaccharide skin-reaction test became more positive after therapy in group A.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Biological Products / therapeutic use*
  • Brain Neoplasms / drug therapy
  • Brain Neoplasms / radiotherapy
  • Brain Neoplasms / therapy*
  • Clinical Trials as Topic
  • Combined Modality Therapy
  • Female
  • Glioma / drug therapy
  • Glioma / radiotherapy
  • Glioma / therapy*
  • Humans
  • Leukopenia / etiology
  • Male
  • Middle Aged
  • Nimustine
  • Nitrosourea Compounds / adverse effects
  • Nitrosourea Compounds / therapeutic use
  • Picibanil / adverse effects
  • Picibanil / therapeutic use*
  • Random Allocation
  • Skin Tests

Substances

  • Biological Products
  • Nitrosourea Compounds
  • Nimustine
  • Picibanil