Abstract
BackgroundThis study is a pre-planned country-specific subanalysis of results in Germany from a multinational multicenter registry to prospectively assess real-world experience with caspofungin administered for treatment of proven or probable invasive aspergillosis (IA).MethodsData from patients treated with caspofungin for a single episode of IA were collected. Effectiveness was determined by the local investigator as favorable (complete or partial response) or unfavorable (stable disease, failure or death) at the end of caspofungin therapy. Descriptive statistics with binomial exact confidence intervals were employed.ResultsForty-two consecutive patients were identified in three German centers. Three patients (7%) had proven IA and 39/42 (93%) had probable IA (modified European Organization for Research and Treatment of Cancer/Mycosis Study Group (EORTC/MSG) criteria). Forty-one patients had pulmonary IA and one had tracheal IA. Caspofungin monotherapy was received by 36/42 patients (86%); of these, 26/36 (72%) received salvage therapy. A favorable response was observed in 29/42 patients (69%; 95% CI 53 to 82%); of these, 21/29 (72%) had a complete and 8/29 (28%) a partial response. Favorable response rate was 69% in patients with monotherapy (95% CI 52% to 84%; 25/36 patients), and 67% in patients receiving combination therapy (95% CI 22% to 96%; 4/6 patients). Favorable response rate in patients with first line therapy was 64% (95% CI 31% to 89%; 7/11 patients), and 73% in patients with second line therapy (95% CI 54% to 88%; 20/30 patients). No adverse events were reported. In total, 35/42 patients (83%; 95% CI 69 to 93%) survived seven days after completion of caspofungin therapy.ConclusionsThese real-life findings in Germany are consistent with the international findings from this registry and with findings from randomized studies.
Highlights
Invasive aspergillosis poses a major threat to patients with hematologic diseases and can greatly jeopardize the success of treatment of the underlying condition [1]
Caspofungin is the only echinocandin presently licensed in Europe for the treatment of invasive aspergillosis, being approved for the treatment of invasive aspergillosis in adult and pediatric patients who are refractory to or intolerant of, for example, amphotericin B and as empirical therapy for presumed fungal infections in febrile neutropenic adult or pediatric patients [6]
Inclusion criteria were informed consent by the patient, age at least 16 years, a diagnosis of proven or probable invasive aspergillosis, mono- or combination therapy with caspofungin, and non-participation in any clinical trial on antimycotic therapy sponsored by MSD or Merck & Co
Summary
Invasive aspergillosis poses a major threat to patients with hematologic diseases and can greatly jeopardize the success of treatment of the underlying condition [1]. Caspofungin is the only echinocandin presently licensed in Europe for the treatment of invasive aspergillosis, being approved for the treatment of invasive aspergillosis in adult and pediatric patients who are refractory to or intolerant of, for example, amphotericin B and as empirical therapy for presumed fungal infections (such as Candida or Aspergillus) in febrile neutropenic adult or pediatric patients [6]. As data from Germany on this disease have not previously been available, we present here the results of a pre-planned national subanalysis. This study is a pre-planned country-specific subanalysis of results in Germany from a multinational multicenter registry to prospectively assess real-world experience with caspofungin administered for treatment of proven or probable invasive aspergillosis (IA)
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