Randomized trial of influenza vaccine with granulocyte-macrophage colony-stimulating factor or placebo in cancer patients

Ramesh K. Ramanathan, Douglas M. Potter, Chandra Belani, Samuel A. Jacobs, Stefan Gravenstein, Felix Lim, Hyoung Kim, Steven Savona, Terry Evans, Dianne Buchbarker, Mary B. Simon, Jane K. Depee, Donald L. Trump

Research output: Contribution to journalArticle

30 Citations (Scopus)

Abstract

Purpose: To determine whether granulocyte-macrophage colony-stimulating factor (GM-CSF) would improve response to influenza vaccination in cancer patients. Patients and 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 μg 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 ≥ .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) Conclusion: A single 250-μg 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.

Original languageEnglish (US)
Pages (from-to)4313-4318
Number of pages6
JournalJournal of Clinical Oncology
Volume20
Issue number21
DOIs
StatePublished - Nov 1 2002

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Influenza Vaccines
Granulocyte-Macrophage Colony-Stimulating Factor
Placebos
Neoplasms
Vaccination
Human Influenza
Hemagglutination
Vaccines
Confidence Intervals

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

Cite this

Ramanathan, Ramesh K. ; Potter, Douglas M. ; Belani, Chandra ; Jacobs, Samuel A. ; Gravenstein, Stefan ; Lim, Felix ; Kim, Hyoung ; Savona, Steven ; Evans, Terry ; Buchbarker, Dianne ; Simon, Mary B. ; Depee, Jane K. ; Trump, Donald L. / Randomized trial of influenza vaccine with granulocyte-macrophage colony-stimulating factor or placebo in cancer patients. In: Journal of Clinical Oncology. 2002 ; Vol. 20, No. 21. pp. 4313-4318.
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title = "Randomized trial of influenza vaccine with granulocyte-macrophage colony-stimulating factor or placebo in cancer patients",
abstract = "Purpose: To determine whether granulocyte-macrophage colony-stimulating factor (GM-CSF) would improve response to influenza vaccination in cancer patients. Patients and 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 μg 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 ≥ .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) Conclusion: A single 250-μg 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.",
author = "Ramanathan, {Ramesh K.} and Potter, {Douglas M.} and Chandra Belani and Jacobs, {Samuel A.} and Stefan Gravenstein and Felix Lim and Hyoung Kim and Steven Savona and Terry Evans and Dianne Buchbarker and Simon, {Mary B.} and Depee, {Jane K.} and Trump, {Donald L.}",
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Ramanathan, RK, Potter, DM, Belani, C, Jacobs, SA, Gravenstein, S, Lim, F, Kim, H, Savona, S, Evans, T, Buchbarker, D, Simon, MB, Depee, JK & Trump, DL 2002, 'Randomized trial of influenza vaccine with granulocyte-macrophage colony-stimulating factor or placebo in cancer patients', Journal of Clinical Oncology, vol. 20, no. 21, pp. 4313-4318. https://doi.org/10.1200/JCO.2002.02.041

Randomized trial of influenza vaccine with granulocyte-macrophage colony-stimulating factor or placebo in cancer patients. / Ramanathan, Ramesh K.; Potter, Douglas M.; Belani, Chandra; Jacobs, Samuel A.; Gravenstein, Stefan; Lim, Felix; Kim, Hyoung; Savona, Steven; Evans, Terry; Buchbarker, Dianne; Simon, Mary B.; Depee, Jane K.; Trump, Donald L.

In: Journal of Clinical Oncology, Vol. 20, No. 21, 01.11.2002, p. 4313-4318.

Research output: Contribution to journalArticle

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T1 - Randomized trial of influenza vaccine with granulocyte-macrophage colony-stimulating factor or placebo in cancer patients

AU - Ramanathan, Ramesh K.

AU - Potter, Douglas M.

AU - Belani, Chandra

AU - Jacobs, Samuel A.

AU - Gravenstein, Stefan

AU - Lim, Felix

AU - Kim, Hyoung

AU - Savona, Steven

AU - Evans, Terry

AU - Buchbarker, Dianne

AU - Simon, Mary B.

AU - Depee, Jane K.

AU - Trump, Donald L.

PY - 2002/11/1

Y1 - 2002/11/1

N2 - Purpose: To determine whether granulocyte-macrophage colony-stimulating factor (GM-CSF) would improve response to influenza vaccination in cancer patients. Patients and 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 μg 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 ≥ .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) Conclusion: A single 250-μg 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.

AB - Purpose: To determine whether granulocyte-macrophage colony-stimulating factor (GM-CSF) would improve response to influenza vaccination in cancer patients. Patients and 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 μg 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 ≥ .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) Conclusion: A single 250-μg 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.

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