RANDOMIZED TRIAL COMPARING THE TOLERABILITY OF SARGRAMOSTIM (YEAST-DERIVED RHUGM-CSF) AND FILGRASTIM (BACTERIA-DERIVED RHUG-CSF) IN CANCER-PATIENTS RECEIVING MYELOSUPPRESSIVE CHEMOTHERAPY

A prospective, randomized, double-blind, multicenter study in cancer p atients receiving myelosuppressive chemotherapy was undertaken to eval uate and compare the tolerability of sargramostim (yeast-derived recom binant human granulocyte-macrophage colony-stimulating factor, RhuGM-C SF) and filgrastim (bacteria-derived recombinant human granulocyte col ony-stimulating factor, RhuG-CSF) in the prophylaxis or treatment of c hemotherapy-induced neutropenia. In all, 137 evaluable patients receiv ed sargramostim (300 mu g; 193 mg/m(2)) or filgrastim (481 mg; 7 mg/kg ) once daily by self-administered s.c. injection, usually beginning wi thin 48 h after completion of chemotherapy. With the exception of a sl ightly higher incidence of grade 1 fever (< 38.1 degrees C) with sargr amostim, there were no statistically significant differences in the in cidence or severity of local or systemic adverse events possibly relat ed to the growth factors, Although the study was not designed to evalu ate efficacy directly, there also were no statistically significant di fferences between treatment groups in total days of growth factor ther apy, days of hospitalization, or days of i.v. antibiotic therapy durin g the treatment period. Both sargramostim and filgrastim were comparab ly well tolerated when given by s.c. injection in this group of patien ts, and no clinically significant differences between the growth facto rs were demonstrated.