A prospective randomized trial of thymopentin versus granulocyte--colony stimulating factor with or without thymopentin in the prevention of febrile episodes in cancer patients undergoing highly cytotoxic chemotherapy

Anticancer Res. Mar-Apr 1994;14(2B):731-4.

Abstract

One hundred patients with advanced carcinoma undergoing highly cytotoxic chemotherapy were enrolled in a prospective randomized trial comparing subcutaneous G-CSF, thymopentin, a combination of the two, and placebo as preventive treatment of febrile leukopenia. Data from this study show that G-CSF was very active in reducing the incidence of chemotherapy-related fever and leukopenia as compared to placebo (22% versus 64%). This difference was statistically highly significant (P < 0.001). Thymopentin was associated with a reduction in febrile episodes as compared to placebo (52% versus 64%), but this difference did not reach statistical significance. Moreover, the addition of thymopentin to G-CSF did not result in a statistically significant improvement of results obtained with G-CSF alone. Similar results were achieved for fungal infections. Tolerance to thymopentin was excellent, while less than 9% of patients on G-CSF treatment complained of mild nausea and generalized bone pain.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Agents / therapeutic use
  • Antineoplastic Agents / toxicity*
  • Breast Neoplasms / drug therapy
  • Endometrial Neoplasms / drug therapy
  • Female
  • Fever / prevention & control*
  • Granulocyte Colony-Stimulating Factor / adverse effects
  • Granulocyte Colony-Stimulating Factor / therapeutic use*
  • Head and Neck Neoplasms / drug therapy
  • Humans
  • Incidence
  • Lung Neoplasms / drug therapy
  • Male
  • Middle Aged
  • Mycoses / epidemiology
  • Neoplasms / drug therapy*
  • Neutropenia / epidemiology
  • Neutropenia / prevention & control
  • Ovarian Neoplasms / drug therapy
  • Prospective Studies
  • Stomach Neoplasms / drug therapy
  • Thymopentin / adverse effects
  • Thymopentin / therapeutic use*

Substances

  • Antineoplastic Agents
  • Granulocyte Colony-Stimulating Factor
  • Thymopentin