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Ohnmacht GA, Phan GQ, Mavroukakis SA, et al. 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. J Immunother (1991). 2001;24(2):188-192
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 : official journal of the Society for Biological Therapy, 24(2), 188-192.
Ohnmacht, Galen A., et al. "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 : official journal of the Society for Biological Therapy vol. 24,2 (2001): 188-192.
Ohnmacht GA, Phan GQ, Mavroukakis SA, Steinberg SM, Shea YR, Witebsky FG, McIntyre LS, Goodwin RS, Muehlbauer PM, Morton KE, Rogers-Freezer LJ, Seipp CA, Rosenberg SA, Marincola FM. 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. J Immunother (1991). 2001 Mar;24(2):188-192. PMID: 11449076.
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J Immunother (1991). 2001 Mar;24(2):188-192.

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 : official journal of the Society for Biological Therapy

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

Affiliations

  1. Surgery Branch, National Cancer Institute; Biostatistics and Data Management Section, Division of Clinical Sciences, National Cancer Institute; Clinical Pathology Department, Clinical Center; Clinical Center Nursing Department; and Department of Transfusion Medicine, Clinical Center, National Institutes of Health, Bethesda, Maryland, U.S.A.

PMID: 11449076

Abstract

SUMMARY: 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.

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