Invasive Candidiasis in Patients with Solid Tumors Treated with Anidulafungin: A Post Hoc Analysis of Efficacy and Safety of Six Pooled Studies

Francesco Giuseppe De Rosa, Alessandro Busca, Maria Rita Capparella, Jean Li Yan, Jalal A Aram, Francesco Giuseppe De Rosa, Alessandro Busca, Maria Rita Capparella, Jean Li Yan, Jalal A Aram

Abstract

Background: Solid tumors are a common predisposing factor for invasive candidiasis (IC) or candidemia due to IC.

Objectives: Post hoc analysis of patient-level efficacy and safety data from six studies of anidulafungin (with similar protocols/endpoints) in adults with IC/candidemia summarized by past or recent diagnosis of solid tumors.

Patients/methods: Patients received a single intravenous (IV) dose of anidulafungin 200 mg, followed by 100 mg once daily. After ≥ 5 to ≥ 10 days of IV treatment, switch to oral voriconazole/fluconazole was permitted in all but one study. Time of solid tumor diagnosis was defined as past, ≥ 6; and recent, < 6 months prior to study entry. Primary endpoint: global response of success (GRS) rate at the end of IV therapy (EOIVT). Secondary endpoints included the GRS rate at the end of all therapy (EOT), all-cause mortality, and safety.

Results: The GRS rate in the overall population was 73.4% at EOIVT and 65.5% at EOT. Past or recent solid tumor diagnosis did not affect GRS at EOIVT or EOT (past: 75.5% and 71.4%; recent: 72.2% and 62.2%, respectively). All-cause mortality was 14.4% on day 14 and 20.1% at day 28. Most treatment-emergent adverse events were mild/moderate in severity (81.6%).

Conclusions: Treatment of IC was effective regardless of the time of solid tumor diagnosis.

Trial registration: Data were pooled from six studies: NCT00496197 (first posted on ClinicalTrials.gov on July 4, 2007); NCT00548262 (first posted on ClinicalTrials.gov on October 23, 2007); NCT00537329 (first posted on ClinicalTrials.gov on October 1, 2007); NCT00689338 (first posted on ClinicalTrials.gov on June 3, 2008); NCT00806351 (first posted on ClinicalTrials.gov on December 10, 2008); NCT00805740 (first posted on ClinicalTrials.gov on December 10, 2008).

Conflict of interest statement

FDR has received speaker grants and participated in advisory boards for Angelini, Basilea, Biomereuix, BioTest, Correvio, Gilead Sciences, Hikma, MSD, Nordic Pharma, Sanofi Aventis, Pfizer Inc, and ThermoFisher. AB has received honoraria from Gilead Sciences, Jazz Pharmaceuticals, Merck, and Pfizer Inc; he has been speaker for Gilead Sciences, Merck, Novartis, and Pfizer Inc, and has served on Advisory Boards for Gilead Sciences and Pfizer Inc. JAA, JLY, and MRC are employees and shareholders of Pfizer Inc.

Figures

Fig. 1
Fig. 1
Anidulafungin global response success rates at EOIVT and EOT by the time of solid tumor diagnosis (mITT, N = 139). EOIVT end of intravenous treatment; EOT end of treatment; m months; ns not significant based on Fisher’s exact test. Past diagnosis of solid tumors, ≥ 6 months prior to study entry; recent diagnosis, < 6 months before study entry

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