Empirical Versus Preemptive Antifungal Therapy

Summary

RATIONALE: Caspofungin acetate may be effective in treating fungal infections in patients with acute myeloid leukemia or myelodysplastic syndrome who are receiving treatment for their cancer. It is not yet known whether caspofungin acetate is more effective when treatment starts after development of a fever or after the infection is shown in laboratory test, chest x-ray, or CT scan. PURPOSE: This randomized phase III trial is studying the best time to start caspofungin acetate therapy in treating patients with acute myeloid leukemia or myelodysplastic syndrome that is newly diagnosed or in first relapse.

Timeline

Start

2012-03

Primary completion

2019-04-04

Completion

2019-04-04

Outcome

Met primary endpoint

paper At day 42, the OS was not inferior in arm B (96.7%; 95% confidence interval [CI], 93.8%-98.3%) PMID 35906831 ↗

Publications

• Maertens J, Lodewyck T, Donnelly JP, Chantepie S, Robin C, Blijlevens N, Turlure P, Selleslag D, Baron F, Aoun M, Heinz WJ, Bertz H, Racil Z, Vandercam B, Drgona L, Coiteux V, Llorente CC, Schaefer-Prokop C, Paesmans M, Ameye L, Meert L, Cheung KJ, Hepler DA, Loeffler J, Barnes R, Marchetti O, Verweij P, Lamoth F, Bochud PY, Schwarzinger M, Cordonnier C; Infectious Diseases Group and the Acute Leukemia Group of the European Organization for Research and Treatment of Cancer. Empiric vs Preemptive Antifungal Strategy in High-Risk Neutropenic Patients on Fluconazole Prophylaxis: A Randomized Trial of the European Organization for Research and Treatment of Cancer. Clin Infect Dis. 2023 Feb 18;76(4):674-682. doi: 10.1093/cid/ciac623.

Drugs

Indications