Itraconazole versus amphotericin B plus nystatin in the prophylaxis of fungal infections in neutropenic cancer patients

The efficacy and safety of itraconazole oral solution and a combination of amphotericin B capsules plus nystatin oral suspension were compared in the prophylaxis of fungal infections in neutropenic patients. In an open, rando mized, multicentre trial, 144 patients received itraconazole oral solution 100 mg bd, and 133 patients received amphotericin B 500 mg tds plus nystati n 2 MU qds. Overall, 65% of itraconazole-treated patients were considered t o have had successful prophylaxis, compared with 53% in the polyene group. Proven deep fungal infections occurred in 5% of patients in each group. Few er patients receiving itraconazole than amphotericin plus nystatin had supe rficial infections (3 versus 8%; P = 0.066). This trend in favour of itraco nazole was seen in patients with profound neutropenia (neutrophil count <0. 1 x 10(9) cells/L at least once) or prolonged neutropenia (neutrophil count <1.0 x 10(9) cells/L for > 14 days). The median time to prophylactic failu re was longer in the itraconazole group (37 days) than in the polyene group (34 days). The number of patients with fungal colonization (nose, sputum, stool) changed more favourably from baseline to endpoint in the itraconazol e group than in the polyene group. Both treatments were safe and well toler ated; however, patients receiving amphotericin plus nystatin had a higher i ncidence of nausea and rash. In conclusion, itraconazole oral solution at d oses of 100 mg bd and oral amphotericin B plus nystatin have similar prophy lactic efficacy against fungal infections in neutropenic patients. On the b asis of reduced incidence of superficial fungal infections, fungal coloniza tion and specific adverse events, itraconazole may be the preferred treatme nt.