Randomized trial of influenza vaccine with granulocyte-macrophage colony-stimulating factor or placebo in cancer patients.
OBJECTIVE
To determine whether granulocyte-macrophage colony-stimulating factor (GM-CSF) would improve response to influenza vaccination in cancer patients.


METHODS
In a randomized, patient-blinded, placebo-controlled trial carried out in 1997 to 2000, 133 patients were stratified into five groups of treatment and disease. Single doses of standard split trivalent influenza vaccine and either placebo or 250 micro g of GM-CSF were administered at the same time. Hemagglutination inhibition assay titers were measured before and 4 weeks after vaccination.


RESULTS
Standard analyses, which define response as at least a four-fold increase in titers, detect no effect of GM-CSF for any of the three influenza subtypes in the trivalent vaccines (P >or=.12). Analysis that includes the magnitude of the change in titers and combines responses of the subtypes suggests that the placebo group had the greater response (P =.051), thus indicating that GM-CSF does not improve response. Ancillary analyses show that response declines both with increasing age and with higher initial titers. The fraction of patients with at least a four-fold increase in titers was 0.36 (95% confidence interval, 0.29 to 0.42)


CONCLUSIONS
A single 250- micro g dose of GM-CSF administered with the influenza vaccine does not improve response to vaccination. Response in cancer patients is low and declines as age and initial titer increase.
Ramanathan
Ramesh K
RK
University of Pittsburgh Cancer Institute, Pittsburgh, PA 15213, USA. ramanathanrk@msx.upmc.edu
Potter
Douglas M
DM
Belani
Chandra P
CP
Jacobs
Samuel A
SA
Gravenstein
Stefan
S
Lim
Felix
F
Kim
Hyoung
H
Savona
Steven
S
Evans
Terry
T
Buchbarker
Dianne
D
Simon
Mary B
MB
Depee
Jane K
JK
Trump
Donald L
DL
D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000917:Antibody Formation; D005260:Female; D016178:Granulocyte-Macrophage Colony-Stimulating Factor / Q000008:administration & dosage* / Q000276:immunology; D006801:Humans; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000276:immunology*; D007251:Influenza, Human / Q000276:immunology / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications*; D016037:Single-Blind Method
D007252:Influenza Vaccines; D016178:Granulocyte-Macrophage Colony-Stimulating Factor