title: 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.
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.
authors.affiliation: Service and Chair of Chemotherapy, Policlinico, University of Palermo, Italy.
authors.forename: V
authors.initials: V
authors.lastname: Gebbia
authors.forename: R
authors.initials: R
authors.lastname: Valenza
authors.forename: A
authors.initials: A
authors.lastname: Testa
authors.forename: G
authors.initials: G
authors.lastname: Cannata
authors.forename: N
authors.initials: N
authors.lastname: Borsellino
authors.forename: N
authors.initials: N
authors.lastname: Gebbia
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use / Q000633:toxicity*; D001943:Breast Neoplasms / Q000188:drug therapy; D016889:Endometrial Neoplasms / Q000188:drug therapy; D005260:Female; D005334:Fever / Q000517:prevention & control*; D016179:Granulocyte Colony-Stimulating Factor / Q000009:adverse effects / Q000627:therapeutic use*; D006258:Head and Neck Neoplasms / Q000188:drug therapy; D006801:Humans; D015994:Incidence; D008175:Lung Neoplasms / Q000188:drug therapy; D008297:Male; D008875:Middle Aged; D009181:Mycoses / Q000453:epidemiology; D009369:Neoplasms / Q000188:drug therapy*; D009503:Neutropenia / Q000453:epidemiology / Q000517:prevention & control; D010051:Ovarian Neoplasms / Q000188:drug therapy; D011446:Prospective Studies; D013274:Stomach Neoplasms / Q000188:drug therapy; D016305:Thymopentin / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000970:Antineoplastic Agents; D016179:Granulocyte Colony-Stimulating Factor; D016305:Thymopentin