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Antimicrobial Agents and Chemotherapy, January 2006, p. 143-147, Vol. 50, No. 1
0066-4804/06/$08.00+0     doi:10.1128/AAC.50.1.143-147.2006
Copyright © 2006, American Society for Microbiology. All Rights Reserved.

Open-Label, Randomized Comparison of Itraconazole versus Caspofungin for Prophylaxis in Patients with Hematologic Malignancies

Gloria N. Mattiuzzi,1* Gladys Alvarado,1 Francis J. Giles,1 Luis Ostrosky-Zeichner,2 Jorge Cortes,1 Susan O'Brien,1 Srdan Verstovsek,1 Stefan Faderl,1 Xian Zhou,3 Issam I. Raad,4,5 B. Nebiyou Bekele,3 G. J. Leitz,6 Ivonne Lopez-Roman,1 and Elihu H. Estey1

Departments of Leukemia,1 Biostatistics and Applied Mathematics,3 Infectious Disease,4 Infectious Disease-Infection Control, The University of Texas M. D. Anderson Cancer Center,5 Laboratory of Mycology Research, Division of Infectious Diseases, Department of Internal Medicine, and Center for the Study of Emerging and Re-emerging Pathogens, The University of Texas Houston Medical School, Houston, Texas,2 Ortho Biotech Products, L.P., Bridgewater, New Jersey6

Received 17 May 2005/ Returned for modification 10 June 2005/ Accepted 30 October 2005

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.

* Corresponding author. Mailing address: Department of Leukemia, Unit 428, The University of Texas M. D. Anderson Cancer Center, 1515 Holcombe Blvd., Houston, TX 77030. Phone: (713) 745-2723. Fax: (713) 745-4612. E-mail: gmattiuz{at}mdanderson.org.

Antimicrobial Agents and Chemotherapy, January 2006, p. 143-147, Vol. 50, No. 1
0066-4804/06/$08.00+0     doi:10.1128/AAC.50.1.143-147.2006
Copyright © 2006, American Society for Microbiology. All Rights Reserved.



This article has been cited by other articles:

  • Michallet, M., Ito, J. I. (2009). Approaches to the Management of Invasive Fungal Infections in Hematologic Malignancy and Hematopoietic Cell Transplantation. JCO 27: 3398-3409 [Abstract] [Full Text]  
  • Cornely, O. A., Bohme, A., Buchheidt, D., Einsele, H., Heinz, W. J., Karthaus, M., Krause, S. W., Kruger, W., Maschmeyer, G., Penack, O., Ritter, J., Ruhnke, M., Sandherr, M., Sieniawski, M., Vehreschild, J.-J., Wolf, H.-H., Ullmann, A. J. (2009). Primary prophylaxis of invasive fungal infections in patients with hematologic malignancies. Recommendations of the Infectious Diseases Working Party of the German Society for Haematology and Oncology. haematol 94: 113-122 [Abstract] [Full Text]  
  • Kishel, J. J, Sivik, J. (2008). Breakthrough invasive fungal infection in an immunocompromised host while on posaconazole prophylaxis: an omission in patient counseling and follow-up. J Oncol Pharm Pract 14: 189-193 [Abstract]  
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