TABLE 15: Oropharyngeal Candidiasis Response Rates at 5 to 7 Days Post-Therapy in Patients with Oropharyngeal and Esophageal Candidiasis at Baseline   CANCIDAS Fluconazole % Difference*
(95% CI)
*
Calculated as CANCIDAS – fluconazole 
Day 5-7 post-treatment 40/56 (71.4%) 55/66 (83.3%) -11.9 (-26.8, 3.0)

As shown in Table 16, the oropharyngeal candidiasis relapse rates at the Day 14 and the Day 28 post-treatment visits were statistically significantly higher for CANCIDAS than for fluconazole.

TABLE 16: Oropharyngeal Candidiasis Relapse Rates at 14 and 28 Days Post-Therapy in Patients with Oropharyngeal and Esophageal Candidiasis at Baseline   CANCIDAS Fluconazole % Difference*
(95% CI)
*
Calculated as CANCIDAS – fluconazole 
Day 14 post-treatment
Day 28 post-treatment 17/40 (42.5%)
23/39 (59.0%) 7/53 (13.2%)
18/51 (35.3%) 29.3 (11.5, 47.1)
23.7 (3.4, 43.9)

The results from the two smaller dose-ranging studies corroborate the efficacy of CANCIDAS for esophageal candidiasis that was demonstrated in the larger study.

CANCIDAS was associated with favorable outcomes in 7 of 10 esophageal C. albicans infections refractory to at least 200 mg of fluconazole given for 7 days, although the in vitro susceptibility of the infecting isolates to fluconazole was not known.
14.4 Invasive Aspergillosis
Sixty-nine patients between the ages of 18 and 80 with invasive aspergillosis (IA) were enrolled in an open-label, noncomparative study to eva luate the safety, tolerability, and efficacy of CANCIDAS. Enrolled patients had previously been refractory to or intolerant of other antifungal therapy(ies). Refractory patients were classified as those who had disease progression or failed to improve despite therapy for at least 7 days with amphotericin B, lipid formulations of amphotericin B, itraconazole, or an investigational azole with reported activity against Aspergillus. Intolerance to previous therapy was defined as a doubling of creatinine (or creatinine ≥2.5 mg/dL while on therapy), other acute reactions, or infusion-related toxicity. To be included in the study, patients with pulmonary disease must have had definite (positive tissue histopathology or positive culture from tissue obtained by an invasive procedure) or probable (positive radiographic or computed tomography evidence with supporting culture from bronchoalveolar lavage or sputum, galactomannan enzyme-linked immunosorbent assay, and/or polymerase chain reaction) invasive aspergillosis. Patients with extrapulmonary disease had to have definite invasive aspergillosis. The definitions were modeled after the Mycoses Study Group Criteria [see References (15)]. Patients were administered a single 70-mg loading dose of CANCIDAS and subsequently dosed with 50 mg daily. The mean duration of therapy was 33.7 days, with a range of 1 to 162 days.

An independent expert panel eva luated patient data, including diagnosis of invasive aspergillosis, response and tolerability to previous antifungal therapy, treatment cours