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

E. T. Creagan, D. I. Twito, S. L. Johansson, D. J. Schaid, P. S. Johnson, M. A. Flaum, T. R. Buroker, L. H. Geeraerts, M. H. Veeder, D. H. Gesme, H. A. Homburger

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40 Scopus citations

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 x 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
DOIs
StatePublished - 1991

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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