A safety and feasibility study comparing an intermittent high dose with a daily standard dose of liposomal amphotericin B for persistent neutropenic fever

Journal of Medical Microbiology

Volumn 58, Issue 11, 2009, Pages 1474-1485

  Ellis, Michael ^a   Bernsen, Roos ^a   Ali Zadeh, Hussein ^a,b   Kristensen, Jörgen ^a,b   Hedström, Ulla ^a,c   Poughias, Lazaros ^d   Bresnik, Mark ^e   Al Essa, Awad ^a   Stevens, David A ^f  

^a UNITED ARAB EMIRATES UNIVERSITY   (United Arab Emirates)

^b Tawam Johns Hopkins Hospital   (United Arab Emirates)

^c AL AIN HOSPITAL   (United Arab Emirates)

^d International Medical Affairs   (United Kingdom)

^e GILEAD SCIENCES   (United States)

^f SANTA CLARA VALLEY MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AMPHOTERICIN B LIPID COMPLEX; BETA GLUCAN; CREATININE;

ADOLESCENT; ADULT; ARTICLE; CHILL; CLINICAL ARTICLE; COMORBIDITY; CONTROLLED STUDY; CREATININE BLOOD LEVEL; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG INTERMITTENT THERAPY; DRUG SAFETY; FEBRILE NEUTROPENIA; FEMALE; HUMAN; HYPOKALEMIA; MALE; MYCOSIS; NEPHROTOXICITY; PRIORITY JOURNAL; RIGOR; SIDE EFFECT;

ADOLESCENT; ADULT; AMPHOTERICIN B; ANTIBIOTIC PROPHYLAXIS; ANTIFUNGAL AGENTS; DRUG ADMINISTRATION SCHEDULE; FEASIBILITY STUDIES; FEMALE; FEVER; HUMANS; KIDNEY; LIVER; MALE; MIDDLE AGED; MYCOSES; NEUTROPENIA; TREATMENT OUTCOME; YOUNG ADULT;

EID: 70350517282     PISSN: 00222615     EISSN: None     Source Type: Journal    
DOI: 10.1099/jmm.0.012401-0     Document Type: Article

References (64)

1. Adler-Moore, J. & Proffitt, R. T. (2003). Effect of tissue penetration on AmBisome efficacy. Curr Opin Investig Drugs 4, 179-185. (Pubitemid 36383014)
2. Adler-Moore, J. P. & Proffitt, R. T. (2008). Amphotericin B lipid preparations: what are the differences? Clin Microbiol Infect 14 (Suppl. 4), 25-36.
3. Adler-Moore, J. P., Olson, J. A. & Proffitt, R. T. (2004). Alternative dosing regimens of liposomal amphotericin B (AmBisome) effective in treating murine systemic candidiasis. J Antimicrob Chemother 54, 1096-1102.
4. Bates, D. W., Su, L., Yu, D. T., Chertow, G. M., Seger, D. L., Gomes, D. R., Dasbach, E. J. & Platt, R. (2001). Mortality and costs associated with amphotericin B therapy. Clin Infect Dis 32, 686-693.
5. Bekersky, I., Fielding, R. M., Dressler, D. E., Lee, J. W., Buell, D. N. & Walsh, T. J. (2002). Pharmacokinetics, excretion, and mass balance of liposomal amphotericin B (AmBisome) and amphotericin B deoxycholate in humans. Antimicrob Agents Chemother 46, 828-833. (Pubitemid 34157670)
6. Camp, M. J., Wingard, J. R., Gilmore, C. E., Lin, L. S., Dix, S. P., Davidson, T. G. & Geller, R. B. (1998). Efficacy of low dose dopamine in preventing amphotericin B nephrotoxicity in bone marrow transplant patients and leukemia patients. Antimicrob Agents Chemother 42, 3103-3106.
7. Clark, A. D., McKendrick, S., Tansey, P. J., Franklin, I. M. & Chopra, R. (1998). A comparative analysis of lipid-complexed and liposomal amphotericin B preparations in haematological oncology. Br J Haematol 103, 198-204.
8. Coiffier, B., Lepage, E., Briere, J., Herbrecht, R., Tilly, H., Bouabdallah, R., Morel, P., Van Den Neste, E., Salles, G. & other authors (2002). CHOP chemotherapy plus rituximab compared with CHOP alone in elderly patients with diffuse large-B-cell lymphoma. N Engl J Med 346, 235-242.
9. Collette, N., Van der Auwera, P., Meunier, F., Lambert, C., Sculier, J. P. & Coune, A. (1991). Tissue distribution and bioactivity of amphotericin B administered in liposomes to cancer patients. J Antimicrob Chemother 27, 535-548.
10. Cordonnier, C., Mohty, M., Faucher, C., Vey, N., Pautas, C., Robin, M., Mahi, L. & Ribaud, P. (2005). Safety of a weekly administration of 10 mg/kg of liposomal amphotericin B for antifungal prophylaxis in allogeneic stem-cell transplant and acute leukemia patients. In American Society of Hematology 47th Annual Meeting, 10-13 December 2005, Atlanta, GA, USA, abstract 5346.
11. Cornely, O. A., Maertens, J., Bresnik, M., Ebrahimi, R., Ullmann, A. J., Bouza, E., Heussel, C. P., Lortholary, O., Rieger, C. & other authors (2007). Liposomal amphotericin B as initial therapy for invasive mold infection: a randomized trial comparing a high-loading dose regimen with standard dosing (AmBiload Trial). Clin Infect Dis 44, 1289-1297.
12. Coukell, A. J. & Brogden, R. N. (1998). Liposomal amphotericin B: therapeutic use in the management of fungal infections and visceral leishmaniasis. Drugs 55, 585-612. (Pubitemid 28162079)
13. Demartini, G., Lequaglie, C., Brega Messone, P. P., Scaglione, F. & Fraschini, F. (2005). Penetration of amphotericin B in human lung tissue after single liposomal amphotericin B (AmBisome) infusion. J Chemother 17, 82-85. (Pubitemid 40463762)
14. De Pauw, B., Walsh, T. J., Donnelly, J. P., Stevens, D. A., Edwards, J. E., Calandra, T., Pappas, P. G., Maertens, J., Lortholary, O. & other authors (2008). Revised definitions of invasive fungal disease from the European Organisation for Research and Treatment of Cancer/ Invasive Fungal Infections Cooperative Group and the National Institute of Allergy and Infectious Diseases Mycoses Study Group (EORTC/MSG) Consensus Group. Clin Infect Dis 46, 1813-1821.
15. Deray, G. (2002). Amphotericin B nephrotoxicity. J Antimicrob Chemother 49 (Suppl. 1), 37-41.
16. El-Cheikh, J., Faucher, C., Furst, S., Duran, S., Berger, P., Vey, N., Stoppa, A. M., Bouabdallah, R. & other authors (2007). High dose weekly liposomal amphotericin B antifungal prophylaxis following reduced intensity conditioning allogeneic stem cell transplantation. Bone Marrow Transplant 39, 301-306.
17. Ellis, M. (2002). Invasive fungal infections: evolving challenges for diagnosis and therapeutics. Mol Immunol 38, 947-957. (Pubitemid 34496954)
18. Ellis, M. (2004). Preventing microbial translocation in haematological malignancy. Br J Haematol 125, 282-293.
19. Ellis, M. (2008). New dosing strategies for liposomal amphotericin B in high-risk patients. Clin Microbiol Infect 14 (Suppl. 4), 55-64.
20. Ellis, M. E., al-Hokail, A., Clink, H., Padmos, A., Ernst, P., Spence, D. G., Tharpe, W. N. & Hillier, V. F. (1992). Double blind randomized study of the effect of infusion rates on toxicity of amphotericin B. Antimicrob Agents Chemother 36, 172-179.
21. Ellis, M., Shamoon, A., Gorka, W., Zwaan, F. & al-Ramadi, B. (2001). Severe hepatic injury associated with lipid formulations of amphotericin B. Clin Infect Dis 32, E87-E89.
22. Ellis, M., Hedstrom, U., al-Ramadi, B., Alizadeh, H., Kristensen, J., Kshirsagar, S., Blaschke, T., Stevens, D., Klingspor, L. & Poughias, L. (2007). Pharmacokinetics, efficacy of 3mg/kg/day vs 10mg/kg day 1, 5 mg/kg days 3 and 6 liposomal amphotericin B (Ambisome) in febrile neutropenia. In 8th Congress of the European Association for Clinical Pharmacology and Therapeutics, 29 August-1 September 2007, Amsterdam, the Netherlands, abstract P257.
23. Ellis, M., al-Ramadi, B., Finkelman, M., Hedstrom, U., Kristensen, J., Ali-Zadeh, H. & Klingspor, L. (2008). Assessment of the clinical utility of serial β-D-glucan concentrations in patients with persistent neutropenic fever. J Med Microbiol 57, 287-295.
24. EORTC IATCG (1989). Empiric antifungal therapy in febrile granulocytopenic patients. Am J Med 86, 668-672. (Pubitemid 19149347)
25. Eriksson, U., Seifert, B. & Scaffner, A. (2001). Comparison of effects of amphotericin B deoxycholate infused over 4 or 24 hours: randomized controlled trial. BMJ 322, 579-582. (Pubitemid 32234532)
26. Farag, S. S., Ruppert, A. S., Mrozek, K., Mayer, R. J., Stone, R. M., Carroll, A. J., Powell, B. L., Moore, J. O., Pettanati, M. J. & other authors (2005). Outcome of induction and post-remission therapy in younger adults with acute myeloid leukemia with normal karyotype: a cancer and leukemia group study. J Clin Oncol 23, 482-493.
27. Fleiss, J., Levin, B. & Paik, M. (2003). Statistical Methods for Rates and Proportions, 3rd edn. New York: Wiley Interscience.
28. Francis, P., Lee, J. W., Hoffman, A., Peter, J., Francesconi, A., Bacher, J., Shelhamer, J., Pizzo, P. A. & Walsh, T. J. (1994). Efficacy of unilamellar liposomal amphotericin B in treatment of pulmonary aspergillosis in persistently granulocytopenic rabbits: the potential role of brochoalveolar D-mannitol and serum galactomannan as markers of infection. J Infect Dis 169, 356-368. (Pubitemid 24979072)
29. Garbino, J. & Adam, A. (2006). Use of high-dose liposomal amphotericin B: efficacy and tolerance. Acta Biomed 77 (Suppl. 4), 19-22.
30. Garcia, A., Adler-Moore, J. & Proffitt, R. (2000). Single-dose AmBisome (liposomal amphotericin B) as prophylaxis for murine systemic candidiasis and histoplasmosis. Antimicrob Agents Chemother 44, 2327-2332. (Pubitemid 30650875)
31. Garey, K. W., Rege, M., Pai, M. P., Mingo, D. E., Suda, K. J., Turpin, R. S. & Bearden, D. T. (2006). Time to initiation of fluconazole therapy impacts mortality in patients with candidemia: a multiinstitutional study. Clin Infect Dis 43, 25-31. (Pubitemid 43939072)
32. Goldberg, E., Gafter-Gvili, A., Robenshtok, E., Leibovici, L. & Paul, M. (2008). Empirical antifungal therapy for patients with neutropenia and persistent fever: systematic review and meta-analysis. Eur J Cancer 44, 2192-2203.
33. Greene, R. E., Schlamm, H. T., Oestmann, J. W., Stark, P., Durand, C., Lortholary, O., Wingard, J. R., Herbrecht, R., Ribaud, P. & other authors (2007). Imaging findings in acute invasive pulmonary aspergillosis: clinical significance of the halo sign. Clin Infect Dis 44, 373-379. (Pubitemid 46147619)
34. Gubbins, P. O., Penzak, S. R., Ploston, S., McConnell, S. A. & Anaissie, A. (2002). Characterizing and predicting amphotericin B-associated nephrotoxicity in bone marrow or peripheral blood stem cell transplant recipients. Pharmacotherapy 22, 961-971. (Pubitemid 34831291)
35. Hughes, W. T., Armstrong, D., Bodey, G. P., Bow, E. J., Brown, A. E., Calandra, T., Feld, R., Pizzo, P. A., Rolston, K. V. I. & other authors (2002). 2002 guidelines for the use of antimicrobial agents in neutropenic patients with cancer. Clin Infect Dis 34, 730-751. (Pubitemid 34194843)
36. Kelsey, S. M., Goldman, J. M., McCann, S., Newland, A. C., Scarffe, J. H., Oppenheim, B. A. & Mufti, G. J. (1999). Liposomal amphotericin B (AmBisome) in the prophylaxis of fungal infections in neutropenic patients: a randomized, double-blind placebo-controlled study. Bone Marrow Transplant 23, 163-168. (Pubitemid 29048218)
37. Klastersky, J. (2004). Antifungal therapy in patients with fever and neutropenia - more rational and less empirical? N Engl J Med 351, 1445-1447.
38. Lanternier, F. & Lortholary, O. (2008). Liposomal amphotericin B: what is its role in 2008? Clin Microbiol Infect 14 (Suppl. 4), 71-83.
39. Leenders, A. C., Daenen, S., Jansen, R. L., Hop, W. C., Lowenberg, B., Wijermans, P. W., Cornelissen, J., Herbrecht, R. & other authors (1998). Liposomal amphotericin B compared with amphotericin B deoxycholate in the treatment of documented and suspected neutropenia-associated invasive fungal infections. Br J Haematol 103, 205-212.
40. Marr, K. A. (2008). Primary antifungal prophylaxis in hematopoietic stem cell transplant recipients: clinical implications of recent studies. Curr Opin Infect Dis 21, 409-414.
41. Masiá Canuto, M. M. & Gutiérrez Rodero, F. (2002). Antifungal drug resistance to azoles and polyenes. Lancet Infect Dis 2, 550-563.
42. MRC WPLA (2006). Medical Research Council Acute Lymphoblastic Leukemia Trial XII (UKALL XII), version 4.1, February 2006. Joint Trial with Eastern Cooperative Group (ECOG) - E2993. Protocol for adults with ALL. Modified for intrathecal therapy and Philadelphia Positive ALL, July 2002. Revised May 2005, February 2006. http:// www.ctsu.ox.ac.uk/projects/leuk/ukall2003
43. Mehta, P., Vinks, A., Filipovitch, A., Vaughan, G., Fearing, D., Sper, C. & Davies, S. (2006). High dose weekly AmBisome antifungal prophylaxis in pediatric patients undergoing hematopoietic stem cell transplantation: a pharmacokinetic study. Biol Blood Marrow Transplant 12, 235-240. (Pubitemid 43138018)
44. Meunier, F., Prentice, H. G. & Ringden, O. (1991). Liposomal amphotericin B (AmBisome): safety data from a phase II/III clinical trial. J Antimicrob Chemother 28 (Suppl. B), 83-91.
45. Mills, W., Chopra, R., Linch, D. C. & Goldstone, A. H. (1994). Liposomal amphotericin B in the treatment of fungal infections in neutropenic patients: a single centre experience of 133 episodes in 116 patients. Br J Haematol 86, 754-760. (Pubitemid 24194431)
46. Moen, M. D., Lyseng-Williamson, K. A. & Scott, L. J. (2009). Liposomal amphotericin B: a review of its use as empirical therapy in febrile neutropenia and in the treatment of invasive fungal infections. Drugs 69, 361-392.
47. NCI (1998). Common Toxicity Criteria, version 2.0. Bethesda, MD: National Cancer Institute. http://ctep.cancer.gov/protocolDevelopment/ electronic-applications/docs/ctcv20-4-30-992.pdf.
48. Olson, J. A., Adler-Moore, J., Schwartz, J., Jensen, G. & Proffitt, R. (2006). Comparative efficacies, toxicities, and tissue concentrations of amphotericin B lipid formulations in a murine aspergillosis model. Antimicrob Agents Chemother 50, 2122-2131. (Pubitemid 43807534)
49. Ostrosky-Zeichner, L., Marr, K. A., Rex, J. H. & Cohen, S. H. (2003). Amphotericin B: time for a new 'gold standard'. Clin Infect Dis 37, 415-425.
50. Patterson, T. F., Kirkpatrick, W. R., White, M., Hiemenz, J. W., Wingard, J. R., Dupont, B., Rinaldi, M. G., Stevens, D. A. & Graybill, J. R., for the Aspergillus Study Group (2000). Invasive aspergillosis: disease spectrum, treatment practices, and outcomes. Medicine (Baltimore) 79, 250-260. (Pubitemid 30616973)
51. Penack, O., Schartz, S., Martus, P., Reinwald, M., Schmidt-Hieber, M., Thiel, E. & Blau, I. W. (2006). Low dose liposomal amphotericin B in the prevention of invasive fungal infections in patients with prolonged neutropenia: results from a randomized single center trial. Ann Oncol 17, 1306-1312. (Pubitemid 44288223)
52. Prentice, H. G., Hann, I. M., Herbrecht, R., Aoun, M., Kvaloy, S., Catovsky, D., Pinkerton, C. R., Schey, S. A., Jacobs, F. & other authors (1997). A randomized comparison of liposomal versus conventional amphotericin B for the treatment of pyrexia of unknown origin in neutropenic patients. Br J Haematol 98, 711-718.
53. Saliba, F. & Dupont, B. (2008). Renal impairment and amphotericin B formulations in patients with invasive fungal infections. Med Mycol 46, 97-112.
54. Smith, P. J., Olson, J. A., Constable, D., Schwartz, J., Proffitt, R. T. & Adler-Moore, J. (2007). Effects of dosing regimen on accumulation, retention and prophylactic efficacy of liposomal amphotericin B. J Antimicrob Chemother 59, 941-951. (Pubitemid 47073366)
55. Sobel, J. D. (2006). Design of clinical trials of empiric antifungal therapy in patients with persistent febrile neutropenia: considerations and critiques. Pharmacotherapy 26, 47S-54S.
56. Takemoto, K., Yamamoto, Y., Ueda, Y., Sumita, Y., Yoshida, K. & Niki, Y. (2006a). Comparative study on the efficacy of AmBisome and Fungizone in a mouse model of pulmonary aspergillosis. J Antimicrob Chemother 57, 724-731.
57. Takemoto, K., Yamamoto, Y. & Ueda, Y. (2006b). Evaluation of antifungal pharmacodynamic characteristics of AmBisome against Candida albicans. Microbiol Immunol 50, 579-586. (Pubitemid 44285284)
58. 14C]cholesterol-AmBisome following a single intravenous administration to rats. Drug Metab Dispos 29, 681-685.
59. Vogelsinger, H., Weiler, S., Djanani, A., Kountchev, J., Bellmann- Weiler, R., Wiedermann, C. J. & Bellmann, R. (2006). Amphotericin B distribution in autopsy material after treatment with liposomal amphotericin B and amphotericin B colloidal dispersion. J Antimicrob Chemother 57, 1153-1160. (Pubitemid 44644419)
60. Walsh, T. J., Finberg, R. W., Arndt, C., Hiemenz, J., Schwartz, C., Bodensteiner, D., Pappas, P., Seibel, N., Greenberg, R. N. & other authors (1999). Liposomal amphotericin B for empirical therapy in patients with persisting fever and neutropenia. N Engl J Med 340, 764-771.
61. Walsh, T. J., Goodman, J. L., Pappas, P., Bekersky, I., Buell, D. N., Roden, M., Barrett, J. & Anaissie, A. J. (2001). Safety, tolerance and pharmacokinetics of high-dose liposomal amphotericin B (AmBisome) in patients infected with Aspergillus species and other filamentous fungi: maximum tolerated dose study. Antimicrob Agents Chemother 45, 3487-3496. (Pubitemid 33107867)
62. Walsh, T. J., Pappas, P., Winston, D. J., Lazarus, H. M., Petersen, F., Raffalli, J., Yanovich, S., Stiff, P., Greenberg, R. & other authors (2002). Voriconazole compared with liposomal amphotericin B for empirical antifungal therapy in patients with neutropenia and persistent fever. N Engl J Med 346, 225-234.
63. Walsh, T. J., Teppler, H., Donowitz, G. R., Maertens, J. A., Baden, L. R., Dmoszynska, A., Cornely, O. A., Bourque, M. R., Lupinacci, R. J. & other authors (2004). Caspofungin versus liposomal amphotericin B for empirical antifungal therapy in patients with persistent fever and neutropenia. N Engl J Med 351, 1391-1402.
64. Wingard, J. R., White, M. H., Anaissie, E., Raffalli, J., Goodman, J., Arrieta, A. L. & Amph/ABLC Collaborative Study Group (2000). A randomized double-blind comparative trial evaluating the safety of liposomal amphotericin B versus amphotericin B lipid complex in the empirical treatment of febrile neutropenia. Clin Infect Dis 31, 1155-1163.