Activated (HLA-DR+) T-lymphocyte subsets in cervical carcinoma and effects of radiotherapy and immunotherapy with sizofiran on cell-mediated immunity and survival

Gynecol Oncol. 1995 Mar;56(3):412-20. doi: 10.1006/gyno.1995.1073.


A prospective randomized trial on 312 patients with locally advanced cervical carcinoma (FIGO stages IB-IV) was carried out. The 5-year survival in 90 patients treated with radiotherapy and antitumor polysaccharide sizofiran, an extract from the culture broth of Schizophyllum commune Fries, in combination was significantly (P = 0.045) better than that in 82 patients treated with radiotherapy alone. Treatment with sizofiran and 5-fluorouracil in combination improved (P = 0.003) the 5-year survival in 60 patients treated with radiotherapy. In 244 cervical carcinoma patients, the percentage of activated CD8+ (CD8+HLA-DR+) T cells in the CD8+ T-cell subsets in peripheral lymphocytes increased significantly as the disease progressed. A similar tendency was observed in the percentage of activated CD4+ (CD4+HLA-DR+) T cells in the CD4+ T-cell subsets. These immunologic parameters were significantly increased by radiotherapy, but not by surgery. Sizofiran accelerated a recovery in the activated CD8+ T cells in the CD8+ T-cell subsets compared with that of sizofiran nontreated patients after radiotherapy. Our data show that possible immune impairment in cervical carcinoma may be caused by disturbances in cell-mediated immunity, and that sizofiran is an effective immunotherapeutic agent for cervical carcinoma because it stimulates a rapid recovery of the immunologic parameters impaired by radiotherapy.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • CD4-CD8 Ratio
  • CD4-Positive T-Lymphocytes
  • CD8-Positive T-Lymphocytes
  • Chemotherapy, Adjuvant
  • Combined Modality Therapy
  • Female
  • Fluorouracil / therapeutic use
  • Follow-Up Studies
  • HLA-DR Antigens
  • Humans
  • Immunotherapy
  • Lymphocyte Activation
  • Lymphocyte Count
  • Middle Aged
  • Proportional Hazards Models
  • Prospective Studies
  • Sizofiran / therapeutic use*
  • Survival Rate
  • T-Lymphocyte Subsets* / immunology
  • Uterine Cervical Neoplasms / immunology
  • Uterine Cervical Neoplasms / mortality
  • Uterine Cervical Neoplasms / radiotherapy
  • Uterine Cervical Neoplasms / surgery
  • Uterine Cervical Neoplasms / therapy*


  • HLA-DR Antigens
  • Sizofiran
  • Fluorouracil