* CANCIDAS: 70 mg on Day 1, then 50 mg daily for the remainder of treatment (daily dose increased to 70 mg for 73 patients);

AmBisome: 3.0 mg/kg/day (daily dose increased to 5.0 mg/kg for 74 patients).

** Overall Response: estimated % difference adjusted for strata and expressed as CANCIDAS ¾ AmBisome (95.2% CI); Individual criteria presented above are not mutually exclusive. The percent difference calculated as CANCIDAS ¾ AmBisome.

The rate of successful treatment of documented baseline infections, a component of the primary endpoint, was not statistically different between treatment groups.

The response rates did not differ between treatment groups based on either of the stratification variables: risk category or prior antifungal prophylaxis.

In a Phase III randomized, double-blind study, patients with a proven diagnosis of invasive candidiasis received daily doses of CANCIDAS (50 mg/day following a 70-mg loading dose on Day 1) or amphotericin B deoxycholate (0.6 to 0.7 mg/kg/day for non neutropenic patients and 0.7 to 1.0 mg/kg/day for neutropenic patients). Patients were stratified by both neutropenic status and APACHE II score. Patients with Candida endocarditis, meningitis, or osteomyelitis were excluded from this study.

Patients who met the entry criteria and received one or more doses of IV study therapy were included in the primary (modified intention-to-treat [MITT]) analysis of response at the end of IV study therapy. A favorable response at this time point required both symptom/sign resolution/improvement and microbiological clearance of the Candida infection.

Two hundred thirty-nine patients were enrolled. Patient disposition is shown in Table 2.

TABLE 2

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