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

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).

• Authors: Francesco Giuseppe De Rosa, Alessandro Busca, Maria Rita Capparella, Jean Li Yan, Jalal A Aram
• Journal: Clinical drug investigation (Clin Drug Investig) Vol. 41 Issue 6 Pg. 539-548 (Jun 2021) ISSN: 1179-1918 [Electronic] New Zealand
• PMID: 33891293 (Publication Type: Journal Article, Meta-Analysis)

Chemical References

• Antifungal Agents
• Fluconazole
• Anidulafungin
• Voriconazole

Topics

• Administration, Intravenous
• Anidulafungin (therapeutic use)
• Antifungal Agents (administration & dosage)
• Candidemia (chemically induced)
• Candidiasis, Invasive (drug therapy)
• Fluconazole (administration & dosage)
• Humans
• Neoplasms (complications)
• Treatment Outcome
• Voriconazole (therapeutic use)