Caspofungin Therapy in Documented Fungal Infections: Spanish Experience Before Licensure of the Drug

Cesar Sanz-Rodriguez, Jose M. Aguado, Jose M. Cisneros, Rosario Vivancos, Jorge Gonzalez-Esteban

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Background: The clinical utility of amphotericin B is often limited, with response rates of ~ 35% and significant side effects. Caspofungin has recently been approved by the FDA and EMEA for the treatment of invasive aspergillosis (IAI) in patients who are refractory to or intolerant of other antifungals. We examined the efficacy, safety and tolerability of caspofungin in the treatment of documented fungal infections. Methods: The use of caspofungin in 23 patients with invasive or superficial fungal infections treated between 1-Jun-2001 and 15-Jan-2002 (before licensure of the drug) was retrospectively reviewed. Patients received a loading dose of 70 mg followed by 50-mg daily. All treatments were approved by the Spanish Ministry of Health (Compassionate Use/Foreign Medication Programs) after a detailed review of the cases. Patients were refractory to (22 cases) or intolerant of (1 case) other antifungals. Results: The favorable response rate among patients with proven or probable IAI was 67% (8/12). When possible IAIs were also considered, the favorable response rate was 60% (9/15). The median length of therapy was 15 days (range, 3-54). In patients with esophageal or systemic candidosis the global response rate was 83% (5/6). One patient with a disseminated Fusarium infection did not respond to caspofungin combined with liposomal amphotericin B. Another patient with an invasive mold infection (species not identified) responded partially. Overall, the safety and tolerability profile was favorable; no treatment was discontinued due to caspofungin-related adverse events. Conclusions: Caspofungin was efficacious and generally well tolerated in the treatment of invasive and superficial infections caused by Aspergillus and Candida, and provided an alternative for those who failed to respond or became intolerant to other available antifungals.

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    • ICAAC 42nd