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

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.

• Authors: Shun-Ichi Kimura, Yoshinobu Kanda, Masaki Iino, Takahiro Fukuda, Emiko Sakaida, Tatsuo Oyake, Hiroki Yamaguchi, Shin-Ichiro Fujiwara, Yumi Jo, Akinao Okamoto, Hiroyuki Fujita, Yasushi Takamatsu, Yoshio Saburi, Itaru Matsumura, Jun Yamanouchi, Souichi Shiratori, Moritaka Gotoh, Shingen Nakamura, Kazuo Tamura, Japan Febrile Neutropenia Study Group
• Journal: International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases (Int J Infect Dis) Vol. 100 Pg. 292-297 (Nov 2020) ISSN: 1878-3511 [Electronic] Canada
• PMID: 32891738 (Publication Type: Journal Article, Randomized Controlled Trial)
• Copyright: Copyright © 2020 The Authors. Published by Elsevier Ltd.. All rights reserved.

Chemical References

• Antifungal Agents
• Micafungin

Topics

• Adult
• Aged
• Antifungal Agents (adverse effects, therapeutic use)
• Febrile Neutropenia (drug therapy, immunology)
• Female
• Humans
• Male
• Micafungin (adverse effects, therapeutic use)
• Middle Aged
• Neutrophils (chemistry, drug effects)
• Treatment Outcome
• Young Adult