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.
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.
Gebbia
V
V
Service and Chair of Chemotherapy, Policlinico, University of Palermo, Italy.
Valenza
R
R
Testa
A
A
Cannata
G
G
Borsellino
N
N
Gebbia
N
N
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*
D000970:Antineoplastic Agents; D016179:Granulocyte Colony-Stimulating Factor; D016305:Thymopentin