Success rate and risk factors for failure of empirical antifungal therapy with itraconazole in patients with hematological malignancies: a multicenter, prospective, open-label, observational study in Korea

Soo-Jeong Kim, June-Won Cheong, Yoo Hong Min, Young Jin Choi, Dong-Gun Lee, Je-Hwan Lee, Deok-Hwan Yang, Sang Min Lee, Sung-Hyun Kim, Yang Soo Kim, Jae-Yong Kwak, Jinny Park, Jin Young Kim, Hoon-Gu Kim, Byung Soo Kim, Hun-Mo Ryoo, Jun Ho Jang, Min Kyoung Kim, Hye Jin Kang, In Sung Cho, Yeung Chul Mun, Deog-Yeon Jo, Ho Young Kim, Byeong-Bae Park, Jin Seok Kim, Soo-Jeong Kim, June-Won Cheong, Yoo Hong Min, Young Jin Choi, Dong-Gun Lee, Je-Hwan Lee, Deok-Hwan Yang, Sang Min Lee, Sung-Hyun Kim, Yang Soo Kim, Jae-Yong Kwak, Jinny Park, Jin Young Kim, Hoon-Gu Kim, Byung Soo Kim, Hun-Mo Ryoo, Jun Ho Jang, Min Kyoung Kim, Hye Jin Kang, In Sung Cho, Yeung Chul Mun, Deog-Yeon Jo, Ho Young Kim, Byeong-Bae Park, Jin Seok Kim

Abstract

We assessed the success rate of empirical antifungal therapy with itraconazole and evaluated risk factors for predicting the failure of empirical antifungal therapy. A multicenter, prospective, observational study was performed in patients with hematological malignancies who had neutropenic fever and received empirical antifungal therapy with itraconazole at 22 centers. A total of 391 patients who had abnormal findings on chest imaging tests (31.0%) or a positive result of enzyme immunoassay for serum galactomannan (17.6%) showed a 56.5% overall success rate. Positive galactomannan tests before the initiation of the empirical antifungal therapy (P=0.026, hazard ratio [HR], 2.28; 95% confidence interval [CI], 1.10-4.69) and abnormal findings on the chest imaging tests before initiation of the empirical antifungal therapy (P=0.022, HR, 2.03; 95% CI, 1.11-3.71) were significantly associated with poor outcomes for the empirical antifungal therapy. Eight patients (2.0%) had premature discontinuation of itraconazole therapy due to toxicity. It is suggested that positive galactomannan tests and abnormal findings on the chest imaging tests at the time of initiation of the empirical antifungal therapy are risk factors for predicting the failure of the empirical antifungal therapy with itraconazole. (Clinical Trial Registration on National Cancer Institute website, NCT01060462).

Keywords: Empirical Antifungal Therapy; Galactomannan Test; Hematological Malignancy; Itraconazole.

Conflict of interest statement

The authors declare that they have no competing interests.

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