Empirical Therapy for Presumed Fungal Infections in Patients With Febrile Neutropenia
In the largest empirical antifungal trial to date, CANCIDAS demonstrated efficacy comparable to AmBisome for first-line empirical therapy for presumed fungal infections in patients with febrile neutropenia.
Favorable response (modified intention-to-treat primary analysis).
Favorable overall response to therapy was defined as meeting all 5 secondary end points:
- Survival for 7 days posttreatment
- Prevention of breakthrough fungal infectiona for up to 7 days posttreatment
- Absence of premature discontinuation due to toxicity or lack of efficacy
- Resolution of fever during period of neutropenia
- Successful treatment of baseline fungal infectionb
Drug-related clinical adverse events with an incidence of ≥2% reported in patients treated with CANCIDAS (n=564) in the randomized, double-blind empirical therapy study were fever (CANCIDAS 17.0%, AmBisome 19.4%), chills (13.8%, 24.7%), rash (6.2%, 5.3%), headache (4.3%, 5.7%), hypokalemia (3.7%, 4.2%), nausea (3.5%, 11.3%), vomiting (3.5%, 8.6%), perspiration/diaphoresis (2.8%, 2.2%), diarrhea (2.7%, 2.4%), and dyspnea (2.0%, 4.2%).
Candidemia and Other Candida Infectionsc
A favorable response required both symptom or sign resolution or improvement and microbiologic clearance of the Candida infection.
In a double-blind, randomized clinical trial of patients with candidemia and other Candida infectionsc (n=224), CANCIDAS demonstrated efficacy comparable to amphotericin B. Non-albicans Candida species accounted for 61% of candidemia infections.d, 6
Drug-related clinical adverse events with an incidence of ≥2% reported in patients treated with CANCIDAS (n=114) in the randomized double-blind study of candidemia and other Candida infectionsc were fever (7.0%), chills (5.3%), phlebitis/thrombophlebitis (3.5%), vomiting (3.5%), and diarrhea (2.6%).
A similar number of patients in the treatment groups receiving CANCIDAS and amphotericin B completed the study (55.3% vs 55.2%, respectively), discontinued the study because of clinical adverse events (34.2% vs 34.4%), or discontinued study therapy due to clinical adverse events (26.3% vs 29.6%).
Invasive Aspergillosis
Favorable response=complete resolution (complete response) or clinically meaningful improvement (partial response) of all signs and symptoms and attributable radiographic findings.
In an open-label, noncomparative study in patients with definite or probable aspergillosise who were refractory to or intolerant of standard therapies, CANCIDAS demonstrated efficacy in salvage therapy. CANCIDAS has not been studied as initial therapy for invasive aspergillosis. CANCIDAS is contraindicated in patients with hypersensitivity to any component of this product.
Drug-related clinical adverse events with an incidence of ≥2% reported in patients treated with CANCIDAS (N=69) in the noncomparative aspergillosis study were flushing (2.9%), fever (2.9%), nausea (2.9%), vomiting (2.9%), and infused-vein complications (2.9%).
First-Line Efficacy in Patients With Esophageal Candidiasis
CANCIDAS 50 mg (n=81) demonstrated efficacy comparable to fluconazole 200 mg (n=94) as measured by the following:
- Overall response (81.5% vs 85.1%, respectively)
- Symptom response (90.1% vs 89.4%, respectively)
- Endoscopic response (85.2% vs 86.2%, respectively)
Drug-related clinical adverse events with an incidence of >2% reported in patients treated with CANCIDAS (n=83) in the randomized double-blind study of esophageal candidiasis were phlebitis/thrombophlebitis (15.7%), infused-vein complication (12.0%), nausea (6.0%), headache (6.0%), fever (3.6%), abdominal pain (3.6%), and diarrhea (3.6%).
References
- CANCIDAS is contraindicated in patients with hypersensitivity to any component of this product.
- Concomitant use of CANCIDAS with cyclosporine should be limited to patients for whom the potential benefit outweighs the potential risk of increased hepatic enzyme abnormalities. See the Warning in the Prescribing Information.
- Laboratory abnormalities in liver function tests have been seen in healthy volunteers and patients treated with CANCIDAS. In some patients with serious underlying conditions who were receiving multiple concomitant medications along with CANCIDAS, clinical hepatic abnormalities have also occurred. Isolated cases of significant hepatic dysfunction, hepatitis, or worsening hepatic failure have been reported in patients; a causal relationship to CANCIDAS has not been established. Patients who develop abnormal liver function tests during therapy with CANCIDAS should be monitored for evidence of worsening hepatic function and evaluated for risk/benefit of continuing therapy with CANCIDAS.
Before prescribing CANCIDAS, please read the Prescribing Information.
