Support Care Cancer (1997) 5 : 289–298 Q Springer-Verlag 1997 ORIGINAL ARTICLE Roy A. Beveridge7John A. Miller Arthur N. Kales Richard A. Binder Nicholas J. Robert Janet Heisrath-Evans Kathy Koczyk-Scripka Steven Pashko Michael J. Norgard Harry M. Barnes William R. Taylor Keith A. Thompson L.F. Smith7Winston M. Ueno Robert F. Dobrzynski Robert D. Warren Daniel Katcher7Patrick J. Byrne David M. Dunning Stanley H. Winokur Julian L. Lockey Richard J. Cambareri Thomas P. Butler Robert J. Meister7John M. Fiegert Randomized trial comparing the tolerability of sargramostim (yeast-derived RhuGM-CSF) and filgrastim (bacteria-derived RhuG-CSF) in cancer patients receiving myelosuppressive chemotherapy R.A. Beveridge, M.D. (Y) J.A. Miller, M.D. 7 A.N. Kales, M.D. R.A. Binder, M.D. 7 N.J. Robert, M.D. J. Heisrath-Evans 7 K. Koczyk-Scripka S. Pashko Fairfax-Prince William Hematology Oncology Associates 3289 Woodburn Road, Suite 230, Annandale, VA 22003-1296, USA Tel.: (703) 280–5390 Fax: (703) 280–9596 M.J. Norgard, M.D. 7 H.M. Barnes, M.D. W.R. Taylor, M.D. K.A. Thompson, M.D. Alabama Oncology/Hematology Associates, P.C., Montgomery Cancer Center, 4149 Carmichael Road, Montgomery, AL 36123, USA L.F. Smith, M.D. 7 W.M. Ueno, M.D. R.F. Dobrzynski, M.D. R.D. Warren, M.D. Hematology Oncology Associates, Ltd., 5226 Dames Avenue, Alexandria, VA 22311, USA D. Katcher, M.D. 2296 Opitz Boulevard, Suite 310, Woodbridge, VA 22191, USA P.J. Byrne, M.D. 7 D.M. Dunning, M.D. Northern Virginia Oncology Group, P.C., 4660 Kenmore Avenue, Suite 710, Alexandria, VA 22304, USA S.H. Winokur, M.D. 7 J.L. Lockey, M.D. Georgia Oncology Hematology Clinic, P.C., 993 Johnson Ferry Road, Building D, Suite 430, Atlanta, GA 30342, USA R.J. Cambareri, M.D. 7 T.P. Butler, M.D. R.J. Meister, M.D. 7 J.M. Fiegert, M.D. 1715 North George Mason Drive, Suite 307, Arlington, VA 22205, USA Abstract A prospective, random- ized, double-blind, multicenter study in cancer patients receiving myelosuppressive chemotherapy was undertaken to evaluate and compare the tolerability of sargra- mostim (yeast-derived recombinant human granulocyte-macrophage colony-stimulating factor, RhuGM- CSF) and filgrastim (bacteria-de- rived recombinant human granulo- cyte colony-stimulating factor, RhuG-CSF) in the prophylaxis or treatment of chemotherapy-in- duced neutropenia. In all, 137 eval- uable patients received sargramos- tim (300 mg; 193 mg/m 2 ) or filgras- tim (481 mg; 7 mg/kg) once daily by self-administered s.c. injection, usually beginning within 48 h after completion of chemotherapy. With the exception of a slightly higher incidence of grade 1 fever (~ 38.1 7C) with sargramostim, there were no statistically significant dif- ferences in the incidence or severi- ty of local or systemic adverse events possibly related to the growth factors. Although the study was not designed to evaluate effi- cacy directly, there also were no statistically significant differences between treatment groups in total days of growth factor therapy, days of hospitalization, or days of i.v. antibiotic therapy during the treat- ment period. Both sargramostim and filgrastim were comparably well tolerated when given by s.c. injection in this group of patients, and no clinically significant differ- ences between the growth factors were demonstrated. Key words Growth factors 7 Cytokines 7 Safety 7 Myelosuppression 7 Chemotherapy