* Patients received CANCIDAS 70 mg on Day 1, then 50 mg daily for the remainder of their treatment.

** Calculated as CANCIDAS ¾ amphotericin B

*** 95% CI for candidemia, 95.6% for all patients

† Modified intention-to-treat

†† Includes all patients who either developed a culture-confirmed recurrence of Candida infection or required antifungal therapy for the treatment of a proven or suspected Candida infection in the follow-up period.

†††Study defined as study treatment period and 6-8 week follow-up period.

In this study, the efficacy of CANCIDAS in patients with intra-abdominal abscesses, peritonitis and pleural space Candida infections was evaluated in 19 non-neutropenic patients. Two of these patients had concurrent candidemia. Candida was part of a polymicrobial infection that required adjunctive surgical drainage in 11 of these 19 patients. A favorable response was seen in 9 of 9 patients with peritonitis, 3 of 4 with abscesses (liver, parasplenic, and urinary bladder abscesses), 2 of 2 with pleural space infections, 1 of 2 with mixed peritoneal and pleural infection, 1 of 1 with mixed abdominal abscess and peritonitis, and 0 of 1 with Candida pneumonia.

Overall, across all sites of infection included in the study, the efficacy of CANCIDAS was comparable to that of amphotericin B for the primary endpoint.

In this study, the efficacy data for CANCIDAS in neutropenic patients with candidemia were limited. In a separate compassionate use study, 4 patients with hepatosplenic candidiasis received prolonged therapy with CANCIDAS following other long-term antifungal therapy; three of these patients had a favorable response.

The safety and efficacy of CANCIDAS in the treatment of esophageal candidiasis was evaluated in one large, controlled, noninferiority, clinical trial and two smaller dose response studies.

In all 3 studies, patients were required to have symptoms and microbiological documentation of esophageal candidiasis; most patients had advanced AIDS (with CD4 counts <50/mm³).

Of the 166 patients in the large study who had culture-confirmed esophageal candidiasis at baseline, 120 had Candida albicans and 2 had Candida tropicalis as the sole baseline pathogen whereas 44 had mixed baseline cultures containing C. albicans and one or more additional Candida species.

In the large, randomized, double-blind study comparing CANCIDAS 50 mg/day versus intravenous fluconazole 200 mg/day for the treatment of esophageal candidiasis, patients were treated foran average of 9 days (range 7-21 days). The primary endpoint was favorable overall response at 5 to 7 days following discontinuation of study therapy, which required both complete resolution of symptoms and significant endoscopic improvement. The definition of endoscopic response was based on severity of disease at baseline using a 4-grade scale and required at least a two-grade reduction from baseline endoscopic score or reduction to grade 0 for patients with a baseline score of 2 or less.

The proportion of patients with a favorable overall response for the primary endpoint was comparable for CANCIDAS and fluconazole as shown in Table 4.

* calculated as CANCIDAS ¾ fluconazole

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