A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Effect of Nystatin on the Development of Oral Irritation in Patients Receiving High-Dose Intravenous Interleukin-2

Galen A. Ohnmacht, Giao Q. Phan, Sharon A. Mavroukakis, Seth M. Steinberg, Yvonne R. Shea, Frank G. Witebsky, Lori S. McIntyre, Rose S. Goodwin, Paula M. Muehlbauer, Kathleen E. Morton, Linda J. Rogers-Freezer, Claudia A. Seipp, Steven A. Rosenberg, Francesco M. Marincola

Research output: Contribution to journalArticle

Abstract

Interleukin-2 (IL-2) has been used to treat patients with metastatic melanoma and renal cell cancer for nearly two decades, and much progress has been made in ameliorating its adverse effects. One bothersome adverse effect, oral pain or oral irritation, is usually treated with an oral antifungal antibiotic, nystatin. The authors performed a prospective, randomized, double-blind, placebo-controlled trial involving 64 patients to evaluate the effect of prophylactic administration of nystatin or placebo on the development of oral irritation in patients receiving high-dose intravenous IL-2. No difference was found between patients randomized to receive nystatin or placebo in their rates of development of oral irritation, the severity of IL-2 adverse effects, the duration of their treatment, the rate of development of positive studies for oral yeast, or their pattern of experiencing other adverse effects. Thus, patients who receive high-dose intravenous IL-2 should not be treated prophylactically with nystatin to prevent oral irritation, and clinicians should seek evidence of the presence of oral thrush before using antifungal agents to treat oral pain in these patients.

Original languageEnglish (US)
Pages (from-to)188-192
Number of pages5
JournalJournal of Immunotherapy
Volume24
Issue number2
DOIs
StatePublished - Jan 1 2001

Keywords

  • Interleukin-2
  • Nystatin
  • Oral irritation
  • Oral pain
  • Placebo
  • Prospective randomized trial
  • Thrush

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology
  • Pharmacology
  • Cancer Research

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    Ohnmacht, G. A., Phan, G. Q., Mavroukakis, S. A., Steinberg, S. M., Shea, Y. R., Witebsky, F. G., McIntyre, L. S., Goodwin, R. S., Muehlbauer, P. M., Morton, K. E., Rogers-Freezer, L. J., Seipp, C. A., Rosenberg, S. A., & Marincola, F. M. (2001). A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Effect of Nystatin on the Development of Oral Irritation in Patients Receiving High-Dose Intravenous Interleukin-2. Journal of Immunotherapy, 24(2), 188-192. https://doi.org/10.1097/00002371-200103000-00014