A randomized prospective assessment of recombinant leukocyte A human interferon with or without aspirin in advanced renal adenocarcinoma

Edward T. Creagan, Donald I. Twito, Sonny L. Johansson, Daniel J Schaid, P. Steven Johnson, Morris A. Flaum, Thomas R. Buroker, Louis H. Geeraerts, Michael H. Veeder, Dean H. Gesme, Henry A. Homburger

Research output: Contribution to journalArticle

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Abstract

We performed a prospective, controlled trial of recombinant leukocyte A interferon (IFN-α2A) with or without aspirin (ASA) in 176 patients with assessable advanced renal cell cancer in light of a 34% response rate (10 of 29 patients) from the two-agent regimen in an earlier nonrandomized trial. This encouraging result was substantially higher than the 15% response rate typically achieved with IFN therapy alone. Eighty-seven patients received IFN-α2A 20 × 106 U/m2 intramuscularly three times a week, and 89 received the same IFN therapy with ASA 600 mg orally four times each day. Each group was balanced as to relevant prognostic discriminants. Response rates were 8% for the group receiving ASA in addition to IFN, and 13% for the group receiving IFN alone (P = .30). The median times to progression were 1.9 months for the group receiving IFN with ASA and 2.7 months for the group receiving IFN alone (log-rank P = .36). The median survival durations were 8.8 months for the IFN and ASA group and 8.0 months for the IFN-only group (log-rank P = .60). These figures are also inferior to those typically reported from other studies. Our findings reemphasize the crucial role of randomized trials, admittedly cumbersome and time-consuming, to determine accurately the value of apparently promising therapies. Although some patients may derive benefit from IFN therapy, our findings raise disturbing questions regarding the potential IFN-α2A according to the dose and schedule used in this trial to have any substantive impact on the ultimate outcome of disseminated renal cell cancer.

Original languageEnglish (US)
Pages (from-to)2104-2109
Number of pages6
JournalJournal of Clinical Oncology
Volume9
Issue number12
StatePublished - Dec 1991

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Renal Cell Carcinoma
Interferons
Aspirin
Leukocytes
Proxy
Therapeutics
Interferon-alpha
Appointments and Schedules
Survival

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Creagan, E. T., Twito, D. I., Johansson, S. L., Schaid, D. J., Johnson, P. S., Flaum, M. A., ... Homburger, H. A. (1991). A randomized prospective assessment of recombinant leukocyte A human interferon with or without aspirin in advanced renal adenocarcinoma. Journal of Clinical Oncology, 9(12), 2104-2109.

A randomized prospective assessment of recombinant leukocyte A human interferon with or without aspirin in advanced renal adenocarcinoma. / Creagan, Edward T.; Twito, Donald I.; Johansson, Sonny L.; Schaid, Daniel J; Johnson, P. Steven; Flaum, Morris A.; Buroker, Thomas R.; Geeraerts, Louis H.; Veeder, Michael H.; Gesme, Dean H.; Homburger, Henry A.

In: Journal of Clinical Oncology, Vol. 9, No. 12, 12.1991, p. 2104-2109.

Research output: Contribution to journalArticle

Creagan, ET, Twito, DI, Johansson, SL, Schaid, DJ, Johnson, PS, Flaum, MA, Buroker, TR, Geeraerts, LH, Veeder, MH, Gesme, DH & Homburger, HA 1991, 'A randomized prospective assessment of recombinant leukocyte A human interferon with or without aspirin in advanced renal adenocarcinoma', Journal of Clinical Oncology, vol. 9, no. 12, pp. 2104-2109.
Creagan, Edward T. ; Twito, Donald I. ; Johansson, Sonny L. ; Schaid, Daniel J ; Johnson, P. Steven ; Flaum, Morris A. ; Buroker, Thomas R. ; Geeraerts, Louis H. ; Veeder, Michael H. ; Gesme, Dean H. ; Homburger, Henry A. / A randomized prospective assessment of recombinant leukocyte A human interferon with or without aspirin in advanced renal adenocarcinoma. In: Journal of Clinical Oncology. 1991 ; Vol. 9, No. 12. pp. 2104-2109.
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