A prospective, randomized, double-blind, placebo-controlled trial evaluating the effect of nystatin on the development of oral irritation in patientsreceiving high-dose intravenous interleukin-2

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