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Intravenous and Oral Itraconazole versus Intravenous and Oral Fluconazole for Long-Term Antifungal Prophylaxis in Allogeneic Hematopoietic Stem-Cell Transplant Recipients: A Multicenter, Randomized Trial

Drew J. Winston, MD; Richard T. Maziarz, MD; Pranatharthi H. Chandrasekar, MD; Hillard M. Lazarus, MD; Mitchell Goldman, MD; Jeffrey L. Blumer, PhD, MD; Gerhard J. Leitz, MD, PhD; and Mary C. Territo, MD
[+] Article and Author Information

From UCLA Medical Center, Los Angeles, California; Oregon Health and Sciences University, Portland, Oregon; Harper University Hospital, Wayne State University, Detroit, Michigan; Ireland Cancer Center, University Hospitals of Cleveland, Cleveland, Ohio; Indiana University Hospital, Indianapolis, Indiana; and Ortho Biotech, Raritan, New Jersey.


Acknowledgments: The authors thank Ann Gogesch, RN, UCLA Medical Center, Los Angeles, California, and Mary Steigelman, RN, Harper University Hospital, Detroit, Michigan, for their valuable assistance during the study. They also thank Dr. Ronghua Yang, Larry Broach, and Katie Harding for performing data and statistical analyses and Katharine Fry for preparing the manuscript.

Grant Support: By Janssen Research Foundation, Titusville, New Jersey.

Potential Financial Conflicts of Interest:Employment: G.J. Leitz (Ortho Biotech); Consultancies: J.L. Blumer (Pfizer); Honoraria: D.J. Winston (Ortho Biotech and Pfizer), P.H. Chandrasekar (Pfizer), J.L. Blumer (Pfizer); Grants received: D.J. Winston (Janssen Research Foundation, Ortho Biotech, and Pfizer), P.H. Chandrasekar (Pfizer), M. Goldman (Janssen Research Foundation).

Requests for Single Reprints: Drew J. Winston, MD, Department of Medicine, UCLA Medical Center, Room 42-121 CHS, 10833 Le Conte Avenue, Los Angeles, CA 90095; e-mail, dwinston@mednet.ucla.edu.

Current Author Addresses: Dr. Winston: Department of Medicine, UCLA Medical Center, Room 42-121 CHS, 10833 Le Conte Avenue, Los Angeles, CA 90095.

Dr. Maziarz: Oregon Health and Sciences University, 3181 Southwest Sam Jackson Park Road, Portland, OR 97232.

Dr. Chandrasekar: Harper University Hospital, 4 Brush Center, 3990 John R, Detroit, MI 48201.

Dr. Lazarus: Ireland Cancer Center, University Hospitals of Cleveland, 11100 Euclid Avenue, Cleveland, OH 44106.

Dr. Goldman: Wishard Memorial Hospital, 430 OPW, 1001 West Tenth Street, Indianapolis, IN 46202.

Dr. Blumer: Rainbow Babies and Children's Hospital, 11100 Euclid Avenue, Cleveland, OH 44106.

Dr. Leitz: Ortho Biotech, 430 Route 22 East, Bridgewater, NJ 08807.

Dr. Territo: Department of Medicine, UCLA Medical Center, Room 42-121 CHS, 10833 Le Conte Avenue, Los Angeles, CA 90095.

Author Contributions: Conception and design: D.J. Winston.

Analysis and interpretation of the data: D.J. Winston, G.J. Leitz.

Drafting of the article: D.J. Winston.

Critical revision of the article for important intellectual content: D.J. Winston, R.T. Maziarz, P.H. Chandrasekar, H.M. Lazarus, M. Goldman, J.L. Blumer.

Final approval of the article: D.J. Winston, R.T. Maziarz, P.H. Chandrasekar, M.C. Territo.

Provision of study materials or patients: R.T. Maziarz, P.H. Chandrasekar, H.M. Lazarus, M. Goldman, J.L. Blumer, M.C. Territo.

Obtaining of funding: D.J. Winston.

Administrative, technical, or logistic support: G.J. Leitz.

Collection and assembly of the data: D.J. Winston.


Ann Intern Med. 2003;138(9):705-713. doi:10.7326/0003-4819-138-9-200305060-00006
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In our study, itraconazole was more effective than fluconazole in preventing invasive fungal infection after allogeneic hematopoietic stem-cell transplantation (Table 2, Figure 2). Patients receiving prophylactic itraconazole had fewer invasive fungal infections caused by C. glabrata, C. krusei, and Aspergillus species (Table 3). This reduction in infection is consistent with itraconazole's greater in vitro activity for Aspergillus and some fluconazole-resistant Candida species (1718). Of note, of the 10 fungal isolates causing invasive infection that were available for in vitro susceptibility testing, 8 were resistant to fluconazole and only 1 was resistant to itraconazole. A study of neutropenic patients also showed that oral itraconazole solution provided greater protection than fluconazole against fatal aspergillosis (20).

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Figures

Grahic Jump Location
Figure 2.
Time to development of proven invasive fungal infection in all patients.P

Survival distributions of time to development of proven invasive fungal infection in itraconazole and fluconazole recipients were derived by using Kaplan–Meier product-limit estimates. For the difference in time of onset of proven invasive fungal infection between itraconazole and fluconazole recipients, = 0.01.

Grahic Jump Location
Grahic Jump Location
Figure 3.
Time to development of proven invasive fungal infection in patients with acute graft-versus-host disease (grades 2 to 4).P

Survival distributions of time to development of proven invasive fungal infection in itraconazole and fluconazole recipients were derived by using Kaplan–Meier product-limit estimates. For the difference in time of onset of proven invasive fungal infection between itraconazole and fluconazole recipients, = 0.08.

Grahic Jump Location

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Summary for Patients

Preventing Fungal Infections in Patients with Stem-Cell Transplants

The summary below is from the full report titled “Intravenous and Oral Itraconazole versus Intravenous and Oral Fluconazole for Long-Term Antifungal Prophylaxis in Allogeneic Hematopoietic Stem-Cell Transplant Recipients. A Multicenter, Randomized Trial.” It is in the 6 May 2003 issue of Annals of Internal Medicine (volume 138, pages 705-713). The authors are D.J. Winston, R.T. Maziarz, P.H. Chandrasekar, H.M. Lazarus, M. Goldman, J.L. Blumer, G.J. Leitz, and M.C. Territo.

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