Voriconazole versus itraconazole for antifungal prophylaxis in patients with graft-versus-host disease: A prospective randomized trial.
Yoshiki Hayashi, Yoshinobu Kanda, Hirohisa Nakamae et al.
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In 30 seconds
This randomized phase II selection trial compared 60 days of voriconazole (VRCZ) with itraconazole (ITCZ) prophylaxis in allogeneic HCT recipients with grade II–IV acute GVHD or chronic GVHD requiring systemic corticosteroids. Among 66 randomized patients, protocol-defined prophylaxis success was 88% with VRCZ and 94% with ITCZ (difference, - 6.1 percentage points; 95% confidence interval, - 20.0 to 7.7), and ITCZ was selected under the prespecified rule. Both regimens had high success, but the trial was not powered to establish comparative antifungal efficacy.
Key findings
- Protocol-defined prophylaxis success was 88% with VRCZ and 94% with ITCZ (difference, - 6.1 percentage points; 95% confidence interval, - 20.0 to 7.7).
- No protocol-defined IFI occurred with VRCZ; ITCZ was associated with one probable and one possible IFI.
- Grade 3/4 adverse events occurred in 27% with VRCZ and 21% with ITCZ.
Why it matters
Patients with GVHD requiring systemic corticosteroids are at increased risk of invasive fungal infection after allogeneic HCT. This trial provides comparative feasibility and safety data for two azole prophylaxis regimens in this population. The high protocol-defined success rates are informative, but the study’s selection design and limited power mean the results do not establish that one drug is more effective.
What to keep in mind
The phase II selection trial was not powered to establish comparative antifungal efficacy.