Efficacy and safety of micafungin in empiric and D-index-guided early antifungal therapy for febrile neutropenia; A subgroup analysis of the CEDMIC trial. (November 2020)

• Record Type: Journal Article
• Authors: Kimura, Shun-ichi; Kanda, Yoshinobu; Iino, Masaki; Fukuda, Takahiro; Sakaida, Emiko; Oyake, Tatsuo; Yamaguchi, Hiroki; Fujiwara, Shin-ichiro; Jo, Yumi; Okamoto, Akinao; Fujita, Hiroyuki; Takamatsu, Yasushi; Saburi, Yoshio; Matsumura, Itaru; Yamanouchi, Jun; Shiratori, Souichi; Gotoh, Moritaka; Nakamura, Shingen; Tamura, Kazuo
• Is Part Of: International journal of infectious diseases. Volume 100(2020)
• Page Start: 292
• Page End: 297
• Publication Date: 2020-11
• Subjects: Neutropenia -- D-index -- D-index-guided early antifungal therapy -- Empirical antifungal therapy -- Micafungin; Communicable diseases -- Periodicals; Communicable Diseases -- Periodicals; Communicable diseases; Periodicals; Electronic journals; 616.9
• DOI: 10.1016/j.ijid.2020.08.081
• Languages: English
• ISSNs: 1201-9712

Abstract

Highlights: Micafungin is often used for empirical antifungal therapy (EAT) in Japan. D-index-guided early antifungal therapy (DET) and EAT were compared in CEDMIC trial. Efficacy of micafungin was evaluated in this subgroup analysis of CEMDIC trial. The efficacy of micafungin was 69% in the DET group and 80% in the EAT group. There was comparable efficacy between DET and EAT in high-risk treatment (69% vs 78%, P = 0.30). Abstract: Objectives: The D-index is defined as the area over the neutrophil curve during neutropenia. The CEDMIC trial confirmed the noninferiority of D-index-guided early antifungal therapy (DET) using micafungin to empirical antifungal therapy (EAT). In this study, we evaluated the efficacy and safety of micafungin in these settings. Methods: From the CEDMIC trial, we extracted 67 and 113 patients who received micafungin in the DET and EAT groups, respectively. Treatment success was defined as the fulfilment of all components of a five-part composite end point. Fever resolution was evaluated at seven days after the completion of therapy. Results: The proportion of high-risk treatments including induction chemotherapy for acute leukemia and allogeneic hematopoietic stem cell transplantation was significantly higher in the DET group than in the EAT group (82.1% vs. 52.2%). The efficacy of micafungin was 68.7% (95%CI: 56.2–79.4) and 79.6% (71.0–86.6) in the DET and EAT groups, respectively. When we focused on high-risk treatments, the efficacy was 69.1% (55.2–80.9%) and 78.0% (65.3–87.7%), respectively ( P = 0.30). There was no significant difference in any of the 5 components between the two groups. Conclusions: The efficacy of micafungin in patients undergoing high-risk treatment was not strongly impaired in DET compared to that in EAT.