Abstract

Background: Invasive fungal infection (IFI) is common in neutropenic patients with acute myelogenous leukemia (AML) or myelodysplastic syndrome (MDS). Posaconazole is a broad-spectrum triazole antifungal drug with efficacy in prevention of IFI; however, it has not been previously studied as prophylaxis in a Chinese population. Methods: This multicenter, randomized study in China enrolled AML and MDS patients with persistent chemotherapy-induced neutropenia. Prophylaxis with posaconazole or fluconazole was administered for a maximum of 12 weeks, or until patients recovered from neutropenia and achieved complete remission or an IFI occurred. The primary endpoint was incidence of proven, probable, or possible IFI during treatment. Clinical failure rate, all-cause mortality and time to first systemic antifungal treatment were secondary endpoints. Results: Patients were randomized to receive posaconazole (n = 129) or fluconazole (n = 123); 117 patients in each group were included in the statistical analysis. The incidence of proven, probable or possible IFI was 9.4% (11/117) and 22.2% (26/117) in the posaconazole and fluconazole groups, respectively (p = 0.0114). The clinical failure rate was numerically lower in the posaconazole group (37/117 (31.6%; 95%CI: 23.3 – 40.9)) than in the fluconazole group (49/117 (41.88%; 95% CI: 32.8 – 51.4)) (p = 0.168). Patients receiving posaconazole had a later onset of first systematic antifungal treatment than those receiving fluconazole (p = 0.0139). The most common important adverse events were liver function abnormalities (11 patients (8.8%) on posaconazole and 6 (5.0%) on fluconazole (p = 0.221)). Conclusions: Posaconazole demonstrates efficacy as prophylaxis against IFI in high-risk neutropenic Chinese patients and is well tolerated during long-term use (ClinicalTrials. gov number, NCT00811928).

Author Details

Authors

• Yang Shen¹
• Xiao-Jun Huang²
• Jian-Xiang Wang³
• Jie Jin⁴
• Jian-Da Hu⁵
• Kang Yu⁶
• De-Pei Wu⁷
• Shu-Jie Wang⁸
• Li Yu⁹
• Xie-Qun Chen¹⁰
• Ting Liu¹¹
• Ying-Ming Liang¹²
• Fang-Ping Chen¹³
• Yan Li¹⁴
• Zhi-Xiang Shen¹

Departments

• ¹ Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai,
• ² People Hospital of Beijing University, West City District, Beijing,
• ³ Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin,
• ⁴ First Affiliated Hospital of Zhejiang University, Hangzhou, Zhangjiang,
• ⁵ Fujian Medical University Union Hospital, Gulou, Fuzhou, Fujian,
• ⁶ Wenzhou Medical College, Lucheng, Wenzhou, Zhejiang,
• ⁷ First Affiliated Hospital of Suzhou University, Suzhou, Jiangsu,
• ⁸ Beijing Union Medical College Hospital,
• ⁹ General Hospital of the Chinese People’s Liberation Army, Haidian District, Beijing,
• ¹ 
• ⁰ Xijing Hospital, Xi’an, Shaanxi,
• ¹ 
• ¹ Huaxi Hospital, Chengdu, Sichuan Province,
• ¹ 
• ² Tangdu Hospital, Xi’an, Shaanxi,
• ¹ 
• ³ Xiangya Hospital, Changsha, Hunan, and
• ¹ 
• ⁴ First Affiliated Hospital of China Medical University, Shenyang, Liaoning Province, China

Address

Yang Shen
Rui Jin Hospital
Shanghai Jiao Tong University School of Medicine
Shanghai, China
Email: [email protected]

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