Vehreschild, J. J., Sieniawski, M., Reuter, S., Arenz, D., Reichert, D., Maertens, J., . . . Cornely, O. A. (2009). Efficacy of caspofungin and itraconazole as secondary antifungal prophylaxis: analysis of data from a multinational case registry. International Journal of Antimicrobial Agents, 34, 446–450.

To compare caspofungin and itraconazole as secondary prophylaxis in patients with hematological malignancies.

Physicians completed case report forms via the intranet for data collection and analysis.  Physicians did not follow any specific protocol, drug selection was based upon individual discretion and timing, and dosages of medications used varied. Outcomes were assessed at the end of neutropenia.

• Seventy-seven patients (64% male, 36% female) were included.
• Average age was 48.5 years (range 16–72).
• Seventy percent of patients did not undergo transplantation.  Most of the remaining patients underwent allogeneic stem cell transplantation.

• Multi-site  
• Inpatient 
• Germany

Patients were undergoing the active antitumor treatment phase of care.

This study was observational.

• European Organization for Research and Treatment of Cancer (EORTC)/Mycoses Study Group (MSG) criteria for diagnosis and assessment of first and breakthrough invasive fungal disease (IFD)
• Complete response (defined as a disappearance of all clinical, microbiological, and radiographic evidence of infection)
• Partial response (defined as >50% radiographic signs of infection).

Incidence of breakthrough IFD was similar in both groups of patients (31.9%–32.1%). There were no significant differences between groups in any other outcome measures.  Death attributable to IFD ranged from 3.6% to 4.3%. Aspergillosis was the most frequent infection, followed by candidiasis.  Overall mortality was 16%.
 

No differences were found in efficacy between these two medications; however, no conclusions could be drawn due to multiple study limitations and significant differences between patient groups in the sample.

• Small sample (<100)     
• Baseline sample/group differences of import   
• Risk of bias (no control group, no blinding, no random assignment, sample characteristics*) 
• Key sample group differences that could influence results*
• Measurement validity/reliability questionable*

*Substantial variability in patient characteristics that would influence findings, variability in methods of treatment, other measures used for infection prevention, etc.

This study provided no evidence to differentiate the efficacy between these two medications for secondary antifungal prophylaxis.