Song, A., Yang, D.L., Huang, Y., Jiang, E.L., Yan, Z.S., Wei, J.L., . . . Han, M.Z. (2010). Secondary antifungal prophylaxis in hematological malignancies in a tertiary medical center. International Journal of Hematology, 92, 725–731.

DOI Link

Study Purpose

The purpose of the study was to Investigate efficacy of secondary antifungal prophylaxis (SAP) .  

Intervention Characteristics/Basic Study Process

Primary antifungal prophylaxis was fluconazole 200 mg PO daily. Patients with documented IFI were treated with intensive antifungal therapy. Two of these had complete response prior to futher treatment of primary disease. Thirty-three patients received prophylaxis with voriconazole, 21 received itraconazole, two received micafungin, and one received amphotericin B. The antifungal prophylaxis continued through time of neutropenia and ended when eradication of residual diseases or initiation of salvage therapy due to failure of SAP.

Sample Characteristics

  • 57 patients were included.
  • 149 cycles of therapy
  • Ages ranged from 14-77 years
  • 56% were male, 44% were female
  • 21 patients had AML, 23 had ALL, 2 had NHL, and 1 patient had MDS-RAEB
  • 70% were in complete remission, 30% identified as uncontrolled disease.
  • Medical records for all patients hospitalized for more than two weeks were reviewed.
  • 57 patients who received 149 cycles of therapy were included.
     

Setting

  • Single site  
  • Inpatient stem cell transplantation center  
  • Tianjin, China
     

Phase of Care and Clinical Applications

Active treatment (i.e., chemotherapy or stem cell transplantation)

Study Design

Retrospective chart review

Measurement Instruments/Methods

  • Diagnosis of IFI was according to revised EORTC/MSG criteria: proven cases diagnosed according to pathologic or microbiological evidence.  Probably and possible cases documented by radiological and/or microbiological evidence.
  • Response to antifungal treatment graded according to criteria defined by complete response (CR), pratical response (PR), stable disease (SD), or progressive disease (PD).
  • Relapse defined as recurrence of fungal lesions in historical foci.
  • Breakthrough infection defined as emergence of fungal lesions in other than historical foci.

Results

Median follow-up 120 days (12–1,080) revealed 11 failures of SAP, representing 7.4 per 100 cycles of therapy and cumulative incidence of 24.5% at end of follow-up. Four experienced infection progression, three had infection recurrence, and the other four had breakthrough infection. Of the 11 failures, five occurred in the allo-HSCT and six during chemotherapy. High-dose steroids and neutropenia of more than 14 days were identified as risk factors for SAP failure.

Conclusions

SAP demonstrated high efficacy and can protect further chemotherapy and SCT. Two risk factors, high-dose steroids and neutropenia longer than 14 days, were identified as factors of prophylaxis failure and these patients were deemed to require special consideration.

Limitations

  • Small sample size
  • Retrospective study design
     

Nursing Implications

Based on small sample size and study design, evidence is weak in recommendation for practice.