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

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).

Patients with solid tumor cancers (cancer of internal organs) have increased risk of fungal infections that can spread in the body through the blood. Infection with Candida species, known as invasive candidiasis (IC) (Candida invades the body in places normally free from germs) or candidemia (Candida infection in the blood), can cause severe illness and/or death. Anidulafungin is an antifungal drug recommended to treat IC/candidemia. This post hoc analysis looked at how effective and safe anidulafungin was in adult patients with IC/candidemia with ‘recent’ or ‘past’ history of solid tumors. The analysis included patients diagnosed with cancer less than 6 months before (recent history) or more than 6 months before (past history) they first received anidulafungin. Patients received anidulafungin by injection (intravenously [IV]) into the veins and, for continued treatment, were able to take a different antifungal drug orally. Of 539 patients from six studies, 139 had confirmed IC/candidemia and a history of solid tumors. Approximately 7 out of 10 (72%) patients were cured or no longer had signs of Candida infection at the end of IV anidulafungin treatment. Results were similar in patients with past or recent diagnosis of solid tumors. Treatment side effects reported in approximately 8 out of 10 (82%) patients were mild-to-moderate in severity. This analysis suggests anidulafungin was well tolerated and effective at treating IC/candidemia in patients with solid tumors, whether diagnosed recently or in the past.