Open-label, randomized comparison of itraconazole versus caspofungin for prophylaxis in patients with hematologic malignancies

Gloria N. Mattiuzzi, Gladys Alvarado, Francis J. Giles, Luis Ostrosky-Zeichner, Jorge Cortes, Susan O'Brien, Srdan Verstovsek, Stefan Faderl, Xian Zhou, Issam I. Raad, B. Nebiyou Bekele, G. J. Leitz, Ivonne Lopez-Roman, Elihu H. Estey

Research output: Contribution to journalArticle

Abstract

Invasive fungal infection remains the most common cause of infectious death in acute leukemia. In this open-label, randomized study, we compared the efficacy and safety of caspofungin with that of intravenous itraconazole for antifungal prophylaxis in patients undergoing induction chemotherapy for acute myelogenous leukemia or myelodysplastic syndrome. Of 200 patients, 192 were evaluable for efficacy (86 for itraconazole, 106 for caspofungin). Duration of prophylaxis (median, 21 days [range, 1 to 38 days]), demographics, and prognostic factors were similar in both groups. Ninety-nine patients completed antifungal prophylaxis without developing fungal infection (44 [51%] with itraconazole, 55 [52%] with caspofungin). Twelve patients developed documented invasive fungal infections, five in the itraconazole group (four with candidemia and one with Aspergillus pneumonia), and seven in the caspofungin group (two with candidemia, two with disseminated trichosporon species, two with Aspergillus pneumonia, and one with disseminated Fusarium spp). Two patients in the itraconazole group and four in the caspofungin group died of fungal infection (P = 0.57). Grade 3 to 4 adverse event rates were comparable between groups; the most common event in both was reversible hyperbilirubinemia. No evidence of cardiovascular toxicity from intravenous itraconazole was noted among patients older than 60. In conclusion, intravenous itraconazole and caspofungin provided similar protection against invasive fungal infection during induction chemotherapy, and both drugs were well tolerated.

Original languageEnglish (US)
Pages (from-to)143-147
Number of pages5
JournalAntimicrobial Agents and Chemotherapy
Volume50
Issue number1
DOIs
StatePublished - Jan 1 2006
Externally publishedYes

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caspofungin
Itraconazole
Hematologic Neoplasms
Candidemia
Induction Chemotherapy
Mycoses
Aspergillus
Pneumonia
Trichosporon
Hyperbilirubinemia
Myelodysplastic Syndromes
Fusarium
Acute Myeloid Leukemia
Cause of Death
Leukemia
Demography

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)
  • Infectious Diseases

Cite this

Open-label, randomized comparison of itraconazole versus caspofungin for prophylaxis in patients with hematologic malignancies. / Mattiuzzi, Gloria N.; Alvarado, Gladys; Giles, Francis J.; Ostrosky-Zeichner, Luis; Cortes, Jorge; O'Brien, Susan; Verstovsek, Srdan; Faderl, Stefan; Zhou, Xian; Raad, Issam I.; Bekele, B. Nebiyou; Leitz, G. J.; Lopez-Roman, Ivonne; Estey, Elihu H.

In: Antimicrobial Agents and Chemotherapy, Vol. 50, No. 1, 01.01.2006, p. 143-147.

Research output: Contribution to journalArticle

Mattiuzzi, GN, Alvarado, G, Giles, FJ, Ostrosky-Zeichner, L, Cortes, J, O'Brien, S, Verstovsek, S, Faderl, S, Zhou, X, Raad, II, Bekele, BN, Leitz, GJ, Lopez-Roman, I & Estey, EH 2006, 'Open-label, randomized comparison of itraconazole versus caspofungin for prophylaxis in patients with hematologic malignancies', Antimicrobial Agents and Chemotherapy, vol. 50, no. 1, pp. 143-147. https://doi.org/10.1128/AAC.50.1.143-147.2006
Mattiuzzi, Gloria N. ; Alvarado, Gladys ; Giles, Francis J. ; Ostrosky-Zeichner, Luis ; Cortes, Jorge ; O'Brien, Susan ; Verstovsek, Srdan ; Faderl, Stefan ; Zhou, Xian ; Raad, Issam I. ; Bekele, B. Nebiyou ; Leitz, G. J. ; Lopez-Roman, Ivonne ; Estey, Elihu H. / Open-label, randomized comparison of itraconazole versus caspofungin for prophylaxis in patients with hematologic malignancies. In: Antimicrobial Agents and Chemotherapy. 2006 ; Vol. 50, No. 1. pp. 143-147.
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abstract = "Invasive fungal infection remains the most common cause of infectious death in acute leukemia. In this open-label, randomized study, we compared the efficacy and safety of caspofungin with that of intravenous itraconazole for antifungal prophylaxis in patients undergoing induction chemotherapy for acute myelogenous leukemia or myelodysplastic syndrome. Of 200 patients, 192 were evaluable for efficacy (86 for itraconazole, 106 for caspofungin). Duration of prophylaxis (median, 21 days [range, 1 to 38 days]), demographics, and prognostic factors were similar in both groups. Ninety-nine patients completed antifungal prophylaxis without developing fungal infection (44 [51{\%}] with itraconazole, 55 [52{\%}] with caspofungin). Twelve patients developed documented invasive fungal infections, five in the itraconazole group (four with candidemia and one with Aspergillus pneumonia), and seven in the caspofungin group (two with candidemia, two with disseminated trichosporon species, two with Aspergillus pneumonia, and one with disseminated Fusarium spp). Two patients in the itraconazole group and four in the caspofungin group died of fungal infection (P = 0.57). Grade 3 to 4 adverse event rates were comparable between groups; the most common event in both was reversible hyperbilirubinemia. No evidence of cardiovascular toxicity from intravenous itraconazole was noted among patients older than 60. In conclusion, intravenous itraconazole and caspofungin provided similar protection against invasive fungal infection during induction chemotherapy, and both drugs were well tolerated.",
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AU - Ostrosky-Zeichner, Luis

AU - Cortes, Jorge

AU - O'Brien, Susan

AU - Verstovsek, Srdan

AU - Faderl, Stefan

AU - Zhou, Xian

AU - Raad, Issam I.

AU - Bekele, B. Nebiyou

AU - Leitz, G. J.

AU - Lopez-Roman, Ivonne

AU - Estey, Elihu H.

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