A multicenter phase 2 study of empirical low-dose liposomal amphotericin B in patients with refractory febrile neutropenia. Miyao K., Sawa M., Kurata M., Suzuki R., Sakemura R., Sakai T., Kato T., Sahashi S., Tsushita N., Ozawa Y., Tsuzuki M., Kohno A., Adachi T., Watanabe K., Ohbayashi K., Inagaki Y., Atsuta Y., & Emi N. 2017.
A multicenter phase 2 study of empirical low-dose liposomal amphotericin B in patients with refractory febrile neutropenia [link]Paper  abstract   bibtex   
Invasive fungal infection (IFI) is a major life-threatening problem encountered by patients with hematological malignancies receiving intensive chemotherapy. Empirical antifungal agents are therefore important. Despite the availability of antifungal agents for such situations, the optimal agents and administration methods remain unclear. We conducted a prospective phase 2 study of empirical 1 mg/kg/day liposomal amphotericin B (L-AMB) in 80 patients receiving intensive chemotherapy for hematological malignancies. All enrolled patients were high-risk and had recurrent prolonged febrile neutropenia despite having received broad-spectrum antibacterial therapy for at least 72 hours. Fifty-three patients (66.3 %) achieved the primary endpoint of successful treatment, thus exceeding the predefined threshold success rate. No patients developed IFI. The treatment completion rate was 73.8 %, and only two cases ceased treatment because of adverse events. The most frequent events were reversible electrolyte abnormalities. We consider low-dose L-AMB to provide comparable efficacy and improved safety and cost-effectiveness when compared with other empirical antifungal therapies. Additional large-scale randomized studies are needed to determine the clinical usefulness of L-AMB relative to other empirical antifungal therapies. Copyright © 2016, The Japanese Society of Hematology.
@misc{miyao_k._multicenter_2017,
	title = {A multicenter phase 2 study of empirical low-dose liposomal amphotericin {B} in patients with refractory febrile neutropenia},
	url = {http://www.springer.com/west/home?SGWID=4-102-70-173744104-0&changeHeader=true},
	abstract = {Invasive fungal infection (IFI) is a major life-threatening problem encountered by patients with hematological malignancies receiving intensive chemotherapy. Empirical antifungal agents are therefore important. Despite the availability of antifungal agents for such situations, the optimal agents and administration methods remain unclear. We conducted a prospective phase 2 study of empirical 1 mg/kg/day liposomal amphotericin B (L-AMB) in 80 patients receiving intensive chemotherapy for hematological malignancies. All enrolled patients were high-risk and had recurrent prolonged febrile neutropenia despite having received broad-spectrum antibacterial therapy for at least 72 hours. Fifty-three patients (66.3 \%) achieved the primary endpoint of successful treatment, thus exceeding the predefined threshold success rate. No patients developed IFI. The treatment completion rate was 73.8 \%, and only two cases ceased treatment because of adverse events. The most frequent events were reversible electrolyte abnormalities. We consider low-dose L-AMB to provide comparable efficacy and improved safety and cost-effectiveness when compared with other empirical antifungal therapies. Additional large-scale randomized studies are needed to determine the clinical usefulness of L-AMB relative to other empirical antifungal therapies. Copyright © 2016, The Japanese Society of Hematology.},
	journal = {International Journal of Hematology},
	author = {{Miyao K.} and {Sawa M.} and {Kurata M.} and {Suzuki R.} and {Sakemura R.} and {Sakai T.} and {Kato T.} and {Sahashi S.} and {Tsushita N.} and {Ozawa Y.} and {Tsuzuki M.} and {Kohno A.} and {Adachi T.} and {Watanabe K.} and {Ohbayashi K.} and {Inagaki Y.} and {Atsuta Y.} and {Emi N.}},
	year = {2017},
	keywords = {*amphotericin B lipid complex, *amphotericin B lipid complex/ae [Adverse Drug Reaction], *amphotericin B lipid complex/ct [Clinical Trial], *amphotericin B lipid complex/do [Drug Dose], *amphotericin B lipid complex/dt [Drug Therapy], *amphotericin B lipid complex/iv [Intravenous Drug Administration], *antifungal therapy, *febrile neutropenia, *febrile neutropenia/dt [Drug Therapy], *hematologic malignancy, *recurrent disease/dt [Drug Therapy], Pharmacokinetics, aciclovir, acute lymphoblastic leukemia/dt [Drug Therapy], acute myeloblastic leukemia/dt [Drug Therapy], adolescent, adult, adverse drug reaction, adverse drug reaction/si [Side Effect], aged, antibiotic therapy, antifungal therapy, antineoplastic agent/dt [Drug Therapy], article, cancer chemotherapy, chronic myeloid leukemia/dt [Drug Therapy], congenital malformation, controlled clinical trial, controlled study, cost effectiveness analysis, drug dose increase, drug efficacy, drug safety, drug therapy, electrolyte, febrile neutropenia/dt [Drug Therapy], female, high risk patient, human, infection prevention, intensive care, low drug dose, lymphoma/dt [Drug Therapy], major clinical study, male, multicenter study, multiple myeloma/dt [Drug Therapy], phase 2 clinical trial, prospective study, randomized controlled trial, recurrent disease/dt [Drug Therapy], safety, side effect, systemic mycosis/dt [Drug Therapy], treatment duration}
}
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