Double-blind prospective randomized comparison of interferon gamma-1b versus placebo after autologous stem cell transplantation.
Thirty-eight patients, including 14 with Hodgkin's disease, 9 with non-Hodgkin's lymphomas, 4 with multiple myeloma and 11 with solid tumors, were enrolled in our study. Between March 1995 and March 1997, 24 of these patients had been autografted with peripheral blood, and 14 had received peripheral blood autografts plus bone marrow. The study was a double-blind, prospectively randomized comparison of interferon gamma-1b (IFN-gamma), given subcutaneously at a dose of 50 microg/m(2) daily for 30 days to 18 of the 38 patients, vs. placebo (20 of 38). Administration started after 2 consecutive days of >0.5 x 10(9) neutrophils/l following autologous stem cell transplantation. At a mean follow-up time of 536 +/- 269 days, disease-free survival (DFS) for the IFN-gamma and placebo groups was 728 vs. 510 days, respectively (p < 0.0750 by the Generalized Wilcoxon/Peto-Prentice test). Overall survival (OS) time for the IFN-gamma and placebo groups was 830 vs. 755 days, respectively. Despite the limited number of patients included in this comparison, a trend for superior DFS was observed in the IFN-gamma-treated group, a finding which merits further study.
Koziner
B
B
Bone Marrow Transplant Unit, Clinica Independencia, Munro, Buenos Aires, Argentina. info@oncogroup.com.ar
Dengra
C
C
Cisneros
M
M
Glancszpigel
R
R
D000293:Adolescent; D000328:Adult; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000633:toxicity; D018572:Disease-Free Survival; D004311:Double-Blind Method; D005260:Female; D019337:Hematologic Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000628:therapy; D018380:Hematopoietic Stem Cell Transplantation / Q000379:methods*; D006801:Humans; D007371:Interferon-gamma / Q000008:administration & dosage* / Q000633:toxicity; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000628:therapy; D010919:Placebos / Q000008:administration & dosage; D011446:Prospective Studies; D011994:Recombinant Proteins; D016019:Survival Analysis; D014182:Transplantation, Autologous / Q000379:methods; D016896:Treatment Outcome
D000970:Antineoplastic Agents; D010919:Placebos; D011994:Recombinant Proteins; D007371:Interferon-gamma