Randomized comparison of safety and pharmacokinetics of caspofungin, liposomal amphotericin B, and the combination of both in allogeneic hematopoietic stem cell recipients

Antimicrobial Agents and Chemotherapy

Volumn 54, Issue 10, 2010, Pages 4143-4149

  Groll, Andreas H ^a   Silling, Gerda ^a   Young, Charlotte ^a   Schwerdtfeger, Rainer ^b   Ostermann, Helmut ^c   Heinz, Werner J ^d   Gerss, Joachim ^a   Kolve, Hedwig ^a   Lanvers Kaminsky, Claudia ^a   Pinheiro, João Paulo Vieira ^e   Gammelin, Sibylle ^a   Cornely, Oliver A ^f   Wuerthwein, Gudrun ^a  

^a UNIVERSITY HOSPITAL MÜNSTER   (Germany)

^b DEUTSCHE KLINIK FÜR DIAGNOSTIK   (Germany)

^c LUDWIG MAXIMILIANS UNIVERSITY   (Germany)

^d UNIVERSITY HOSPITAL WÜRZBURG   (Germany)

^e BIELEFELD UNIVERSITY   (Germany)

^f UNIVERSITY OF COLOGNE   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

AMPHOTERICIN B LIPID COMPLEX; BILIRUBIN; CASPOFUNGIN; CREATININE;

ABDOMINAL PAIN; ACIDOSIS; ACUTE GRANULOCYTIC LEUKEMIA; ACUTE LYMPHOCYTIC LEUKEMIA; ADULT; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ALKALINE PHOSPHATASE BLOOD LEVEL; ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION; AMYLASE BLOOD LEVEL; APLASTIC ANEMIA; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BACKACHE; BILIRUBIN BLOOD LEVEL; CHILL; CHRONIC LYMPHATIC LEUKEMIA; CHRONIC MYELOID LEUKEMIA; CLINICAL ASSESSMENT; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CONVALESCENCE; CREATININE BLOOD LEVEL; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG DOSE REGIMEN; DRUG EXPOSURE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPNEA; FEMALE; FEVER; GRAFT FAILURE; GRAFT RECIPIENT; GRAFT VERSUS HOST REACTION; GRANULOCYTOPENIA; HEADACHE; HLA MATCHING; HUMAN; HYPERSENSITIVITY; HYPOKALEMIA; HYPOMAGNESEMIA; IMMUNOCOMPROMISED PATIENT; LOADING DRUG DOSE; MAJOR CLINICAL STUDY; MALE; MAXIMUM PLASMA CONCENTRATION; MONOTHERAPY; MULTICENTER STUDY; MYALGIA; MYELODYSPLASTIC SYNDROME; NAUSEA; NONHODGKIN LYMPHOMA; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RASH; RIGOR; SIDE EFFECT; SURVIVAL; SYSTEMIC MYCOSIS; THORAX PAIN; TRIACYLGLYCEROL LIPASE BLOOD LEVEL; UREMIA; URTICARIA; VOMITING;

ADOLESCENT; ADULT; AGRANULOCYTOSIS; AMPHOTERICIN B; ANTIFUNGAL AGENTS; CHILD; CHILD, PRESCHOOL; DRUG THERAPY, COMBINATION; ECHINOCANDINS; FEMALE; HEMATOPOIETIC STEM CELL TRANSPLANTATION; HUMANS; MALE; MIDDLE AGED; MYCOSES; TRANSPLANTATION, HOMOLOGOUS; TREATMENT OUTCOME; YOUNG ADULT;

EID: 77957346246     PISSN: 00664804     EISSN: 10986596     Source Type: Journal    
DOI: 10.1128/AAC.00425-10     Document Type: Article

References (51)

1. Aliff, T. B., P. G. Maslak, J. G. Jurcic, M. L. Heaney, K. N. Cathcart, K. A. Sepkowitz, and M. A. Weiss. 2003. Refractory Aspergillus pneumonia in patients with acute leukemia: successful therapy with combination caspofungin and liposomal amphotericin. Cancer 97:1025-1032.
2. Ascioglu, S., J. H. Rex, B. de Pauw, J. E. Bennett, J. Bille, F. Crokaert, D. W. Denning, J. P. Donnelly, J. E. Edwards, Z. Erjavec, D. Fiere, O. Lortholary, J. Maertens, J. F. Meis, T. F. Patterson, J. Ritter, D. Selleslag, P. M. Shah, D. A. Stevens, T. J. Walsh, Invasive Fungal Infections Cooperative Group of the European Organization for Research and Treatment of Cancer, and Mycoses Study Group of the National Institute of Allergy and Infectious Diseases.. 2002. Defining opportunistic invasive fungal infections in immunocompromised patients with cancer and hematopoietic stem cell transplants: an international consensus. Clin. Infect. Dis. 34:7-14.
3. Barchiesi, F., E. Spreghini, A. W. Fothergill, D. Arzeni, G. Greganti, D. Giannini, M. G. Rinaldi, and G. Scalise. 2005. Caspofungin in combination with amphotericin B against Candida glabrata. Antimicrob. Agents Chemother. 49:2546-2549.
4. Barchiesi, F., E. Spreghini, S. Tomassetti, D. Giannini, and G. Scalise. 2007. Caspofungin in combination with amphotericin B against Candida parapsilosis. Antimicrob. Agents Chemother. 51:941-945.
5. Bartizal, K., C. J. Gill, G. K. Abruzzo, A. M. Flattery, L. Kong, P. M. Scott, J. G. Smith, C. E. Leighton, A. Bouffard, J. F. Dropinski, and J. Balkovec. 1997. In vitro preclinical evaluation studies with the echinocandin antifungal MK-0991 (L-743,872). Antimicrob. Agents Chemother. 41:2326-2332.
6. Bekersky, I., R. M. Fielding, D. E. Dressler, J. W. Lee, D. N. Buell, and T. J. Walsh. 2002. Pharmacokinetics, excretion, and mass balance of liposomal amphotericin B (AmBisome) and amphotericin B deoxycholate in humans. Antimicrob. Agents Chemother. 46:828-833.
7. Benjamin, D. K. Jr., T. Driscoll, N. L. Seibel, C. E. Gonzalez, M. M. Roden, R. Kilaru, K. Clark, J. A. Dowell, J. Schranz, and T. J. Walsh. 2006. Safety and pharmacokinetics of intravenous anidulafungin in children with neutropenia at high risk for invasive fungal infections. Antimicrob. Agents Chemother. 50:632-638.
8. Bow, E. J. 2009. Invasive fungal infection in haematopoietic stem cell transplant recipients: epidemiology from the transplant physician's viewpoint. Mycopathologia 168:283-297.
9. Caillot, D., A. Thiébaut, R. Herbrecht, S. de Botton, A. Pigneux, F. Bernard, J. Larché, F. Monchecourt, S. Alfandari, and L. Mahi. 2007. Liposomal amphotericin B in combination with caspofungin for invasive aspergillosis in patients with hematologic malignancies: a randomized pilot study (Combistrat trial). Cancer 110:2740-2746. (Pubitemid 350250344)
10. Clemons, K. V., M. Espiritu, R. Parmar, and D. A. Stevens. 2005. Comparative efficacies of conventional amphotericin B, liposomal amphotericin B (AmBisome), caspofungin, micafungin, and voriconazole alone and in combination against experimental murine central nervous system aspergillosis. Antimicrob. Agents Chemother. 49:4867-4875.
11. Cordonnier, C., C. Pautas, S. Maury, A. Vekhoff, H. Farhat, F. Suarez, N. Dhédin, F. Isnard, L. Ades, F. Kuhnowski, F. Foulet, M. Kuentz, P. Maison, S. Bretagne, and M. Schwarzinger. 2009. Empirical versus preemptive antifungal therapy for high-risk, febrile, neutropenic patients: a randomized, controlled trial. Clin. Infect. Dis. 2009 48:1042-1051.
12. Cornely, O. A., J. Maertens, M. Bresnik, R. Ebrahimi, A. J. Ullmann, E. Bouza, C. P. Heussel, O. Lortholary, C. Rieger, A. Boehme, M. Aoun, H. A. Horst, A. Thiebaut, M. Ruhnke, D. Reichert, N. Vianelli, S. W. Krause, E. Olavarria, R. Herbrecht, and the AmBiLoad Trial Study Group. 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.
13. Cornely, O. A., J. Maertens, D. J. Winston, J. Perfect, A. J. Ullmann, T. J. Walsh, D. Helfgott, J. Holowiecki, D. Stockelberg, Y. T. Goh, M. Petrini, C. Hardalo, R. Suresh, and D. Angulo-Gonzalez. 2007. Posaconazole vs. fluconazole or itraconazole prophylaxis in patients with neutropenia. N. Engl. J. Med. 356:348-359.
14. European Organization for Research and Treatment of Cancer (EORTC). 1989. Empiric antifungal therapy in febrile granulocytopenic patients. EORTC International Antimicrobial Therapy Cooperative Group. Am. J. Med. 86:668-672.
15. Groll, A. H., and A. Tragiannidis. 2009. Recent advances in antifungal prevention and treatment. Semin. Hematol. 46:212-229.
16. Groll, A. H., and T. J. Walsh. 2001. Caspofungin: pharmacology, safety and therapeutic potential in superficial and invasive fungal infections. Expert Opin. Invest. Drugs. 10:1545-1558.
17. Groll, A. H., A. Attarbaschi, F. R. Schuster, N. Herzog, L. Grigull, M. N. Dworzak, K. Beutel, H. J. Laws, and T. Lehrnbecher. 2006. Treatment with caspofungin in immunocompromised paediatric patients: a multicentre survey. J. Antimicrob. Chemother. 57:527-535.
18. Groll, A. H., S. C. Piscitelli, and T. J. Walsh. 1998. Clinical pharmacology of systemic antifungal agents: a comprehensive review of agents in clinical use, current investigational compounds, and putative targets for antifungal drug development. Adv. Pharmacol. 44:343-500.
19. Hossain, M. A., G. H. Reyes, L. A. Long, P. K. Mukherjee, and M. A. Ghannoum. 2003. Efficacy of caspofungin combined with amphotericin B against azole-resistant Candida albicans. J. Antimicrob. Chemother. 51:1427-1429.
20. Ibrahim, A. S., T. Gebremariam, Y. Fu, J. E. Edwards, and B. Spellberg. 2008. Combination echinocandin-polyene treatment of murine mucormycosis. Antimicrob. Agents Chemother. 52:1556-1558.
21. Kontoyiannis, D. P., R. Hachem, R. E. Lewis, G. A. Rivero, H. A. Torres, J. Thornby, R. Champlin, H. Kantarjian, G. P. Bodey, and I. I. Raad. 2003. Efficacy and toxicity of caspofungin in combination with liposomal amphotericin B as primary or salvage treatment of invasive aspergillosis in patients with hematologic malignancies. Cancer 98:292-299.
22. Kuse, E. R., P. Chetchotisakd, C. A. da Cunha, M. Ruhnke, C. Barrios, D. Raghunadharao, J. S. Sekhon, A. Freire, V. Ramasubramanian, I. Demeyer, M. Nucci, A. Leelarasamee, F. Jacobs, J. Decruyenaere, D. Pittet, A. J. Ullmann, L. Ostrosky-Zeichner, O. Lortholary, S. Koblinger, H. Diekmann-Berndt, O. A. Cornely, and the Micafungin Invasive Candidiasis Working Group. 2007. Micafungin versus liposomal amphotericin B for candidaemia and invasive candidosis: a phase III randomised double-blind trial. Lancet 369:1519-1527.
23. Lewis, R. E., and D. P. Kontoyiannis. 2001. Rationale for combinations antifungal therapy. Pharmacotherapy 21:149S-164S.
24. Maertens, J., A. Glasmacher, R. Herbrecht, A. Thiebaut, C. Cordonnier, B. H. Segal, J. Killar, A. Taylor, N. Kartsonis, T. F. Patterson, M. Aoun, D. Caillot, C. Sable, and the Caspofungin Combination Therapy Study Group. 2006. Multicenter, noncomparative study of caspofungin in combination with other antifungals as salvage therapy in adults with invasive aspergillosis. Cancer 107:2888-2897.
25. Maertens, J., I. Raad, G. Petrikkos, M. Boogaerts, D. Selleslag, F. B. Petersen, C. A. Sable, N. A. Kartsonis, A. Ngai, A. Taylor, T. F. Patterson, D. W. Denning, T. J. Walsh, and the Caspofungin Salvage Aspergillosis Study Group. 2004. Efficacy and safety of caspofungin for treatment of invasive aspergillosis in patients refractory to or intolerant of conventional antifungal therapy. Clin. Infect. Dis. 39:1563-1571.
26. Maertens, J., K. Theunissen, G. Verhoef, J. Verschakelen, K. Lagrou, E. Verbeken, A. Wilmer, J. Verhaegen, M. Boogaerts, and J. Van Eldere. 2005. Galactomannan and computed tomography-based preemptive antifungal therapy in neutropenic patients at high risk for invasive fungal infection: a prospective feasibility study. Clin. Infect. Dis. 41:1242-1250.
27. Marr, K. A., R. Hachem, G. Papanicolaou, J. Somani, J. M. Arduino, C. J. Lipka, A. L. Ngai, N. Kartsonis, J. Chodakewitz, and C. Sable. 2004. Retrospective study of the hepatic safety profile of patients concomitantly treated with caspofungin and cyclosporin A. Transpl. Infect. Dis. 6:110-116.
28. Mora-Duarte, J., R. Betts, C. Rotstein, A. L. Colombo, L. Thompson-Moya, J. Smietana, R. Lupinacci, C. Sable, N. Kartsonis, J. Perfect, and the Caspofungin Invasive Candidiasis Study Group. 2002. Comparison of caspofungin and amphotericin B for invasive candidiasis. N. Engl. J. Med. 347:2020-2029.
29. Morrissey, C. O., M. A. Slavin, M. A. O'Reilly, J. R. Daffy, J. F. Seymour, A. P. Schwarer, and J. Szer. 2007. Caspofungin as salvage monotherapy for invasive aspergillosis in patients with haematological malignancies or following allogeneic stem cell transplantation: efficacy and concomitant cyclosporin A. Mycoses 50(Suppl. 1):24-37.
30. Olson, J. A., J. P. Adler-Moore, P. J. Smith, and R. T. Proffitt. 2005. Treatment of Candida glabrata infection in immunosuppressed mice by using a combination of liposomal amphotericin B with caspofungin or micafungin. Antimicrob. Agents Chemother. 49:4895-4902.
31. Ostrosky-Zeichner, L. 2008. Combination antifungal therapy: a critical review of the evidence. Clin. Microbiol. Infect. 14(Suppl. 4):65-70.
32. Pappas, P. G., C. M. Rotstein, R. F. Betts, M. Nucci, D. Talwar, J. J. De Waele, J. A. Vazquez, B. F. Dupont, D. L. Horn, L. Ostrosky-Zeichner, A. C. Reboli, B. Suh, R. Digumarti, C. Wu, L. L. Kovanda, L. J. Arnold, and D. N. Buell. 2007. Micafungin versus caspofungin for treatment of candidemia and other forms of invasive candidiasis. Clin. Infect. Dis. 45:883-893. (Erratum, 47:302, 2008.)
33. Pizzo, P. A., K. J. Robichaud, F. A. Gill, and F. G. Witebsky. 1982. Empiric antibiotic and antifungal therapy for cancer patients with prolonged fever and granulocytopenia. Am. J. Med. 72:101-111.
34. Reed, C., R. Bryant, A. S. Ibrahim, J. E. Edwards, S. G. Filler, R. Goldberg, and B. Spellberg. 2008. Combination polyene-caspofungin treatment of rhino-orbital-cerebral mucormycosis. Clin. Infect. Dis. 47:364-371.
35. Sanz-Rodriguez, C., M. Lopez-Duarte, M. Jurado, J. Lopez, R. Arranz, J. M. Cisneros, M. L. Martino, P. J. Garcia-Sanchez, P. Morales, T. Olivé, M. Rovira, and C. Solano. 2004. Safety of the concomitant use of caspofungin and cyclosporin A in patients with invasive fungal infections. Bone Marrow Transplant. 34:13-20. (Pubitemid 39022952)
36. Segal, B. H., N. G. Almyroudis, M. Battiwalla, R. Herbrecht, J. R. Perfect, T. J. Walsh, and J. R. Wingard. 2007. Prevention and early treatment of invasive fungal infection in patients with cancer and neutropenia and in stem cell transplant recipients in the era of newer broad-spectrum antifungal agents and diagnostic adjuncts. Clin. Infect. Dis. 44:402-409.
37. Seibel, N. L., C. Schwartz, A. Arrieta, P. Flynn, A. Shad, E. Albano, J. Keirns, W. M. Lau, D. P. Facklam, D. N. Buell, and T. J. Walsh. 2005. Safety, tolerability, and pharmacokinetics of Micafungin (FK463) in febrile neutropenic pediatric patients. Antimicrob. Agents Chemother. 49:3317-3324.
38. Sionov, E., S. Mendlovic, and F. Segal. 2006. Efficacy of amphotericin B or amphotericin B-intralipid in combination with caspofungin against experimental aspergillosis. J. Infect. 53:131-139. (Pubitemid 44028669)
39. Spellberg, B., T. J. Walsh, D. P. Kontoyiannis, J. E. Edwards, and A. S. Ibrahim. 2009. Recent advances in the management of mucormycosis: from bench to bedside. Clin. Infect. Dis. 48:1743-1751.
40. Stone, J. A., S. D. Holland, P. J. Wickersham, A. Sterrett, M. Schwartz, C. Bonfiglio, M. Hesney, G. A. Winchell, P. J. Deutsch, H. Greenberg, T. L. Hunt, and S. A. Waldman. 2002. Single- and multiple-dose pharmacokinetics of caspofungin in healthy men. Antimicrob. Agents Chemother. 46:739-745.
41. Trenschel, R., M. Ditschkowski, A. H. Elmaagacli, M. Koldehoff, H. Ottinger, N. Steckel, M. Hlinka, R. Peceny, P. M. Rath, H. Dermoumi, and D. W. Beelen. 2005. Caspofungin as second-line therapy for fever of unknown origin or invasive fungal infection following allogeneic stem cell transplantation. Bone Marrow Transplant. 35:583-586.
42. Ullmann, A. J., O. A. Cornely, A. Burchardt, R. Hachem, D. P. Kontoyiannis, K. Töpelt, R. Courtney, D. Wexler, G. Krishna, M. Martinho, G. Corcoran, and I. Raad. 2006. Pharmacokinetics, safety, and efficacy of posaconazole in patients with persistent febrile neutropenia or refractory invasive fungal infection. Antimicrob. Agents Chemother. 50:658-666.
43. Walsh, T. J., R. W. Finberg, C. Arndt, J. Hiemenz, C. Schwartz, D. Bodensteiner, P. Pappas, N. Seibel, R. N. Greenberg, S. Dummer, M. Schuster, and J. S. Holcenberg. 1999. Liposomal amphotericin B for empirical therapy in patients with persistent fever and neutropenia. National Institute of Allergy and Infectious Diseases Mycoses Study Group. N. Engl. J. Med. 340:764-771.
44. Walsh, T. J., V. Yeldandi, M. McEvoy, C. Gonzalez, S. Chanock, A. Freifeld, N. L. Seibel, P. O. Whitcomb, P. Jarosinski, G. Boswell, I. Bekersky, A. Alak, D. Buell, J. Barret, and W. Wilson. 1998. Safety, tolerance, and pharmacokinetics of a small unilamellar liposomal formulation of amphotericin B (AmBisome) in neutropenic patients. Antimicrob. Agents Chemother. 42:2391-2398.
45. Walsh, T. J., H. Teppler, G. R. Donowitz, J. A. Maertens, L. R. Baden, A. Dmoszynska, O. A. Cornely, M. R. Bourque, R. J. Lupinacci, C. A. Sable, and B. E. dePauw. 2004. Caspofungin versus liposomal amphotericin B for empirical antifungal therapy in patients with persistent fever and neutropenia. N. Engl. J. Med. 351:1391-1402.
46. Walsh, T. J., P. C. Adamson, N. H. Seibel, P. M. Flynn, M. N. Neely, C. Schwartz, A. Shad, S. L. Kaplan, M. M. Roden, J. A. Stone, A. Miller, S. K. Bradshaw, S. X. Li, C. A. Sable, and N. A. Kartsonis. 2005. Pharmacokinetics, safety, and tolerability of caspofungin in children and adolescents. Antimicrob. Agents Chemother. 49:4536-4545.
47. Wasan, K. M., O. Sivak, M. Rosland, V. Risovic, and K. Bartlett. 2007. Assessing the antifungal activity, pharmacokinetics, and tissue distribution of amphotericin B following the administration of Abelcet and AmBisome in combination with caspofungin to rats infected with Aspergillus fumigatus. J. Pharm. Sci. 96:1737-1747.
48. Wheat, L. J. 2003. Combination therapy for aspergillosis: is it needed, and which combination? J. Infect. Dis. 187:1831-1833.
49. Wilson, D. T., R. H. Drew, and J. R. Perfect. 2009. Antifungal therapy for invasive fungal diseases in allogeneic stem cell transplant recipients: an update. Mycopathologia 168:313-327.
50. Wirk, B., and J. R. Wingard. 2008. Combination antifungal therapy: from bench to bedside. Curr. Fungal Infect. Rep. 2:43-48.
51. Wuerthwein, G., C. Young, C. Lanvers-Kaminsky, G. Silling, G. Hempel, J. Boos, and A. H. Groll. 2009. Population pharmacokinetics of liposomal amphotericin B, caspofungin and the combination of both in allogeneic hematopoietic stem cell recipients, abstr. A1-591′ Abstr. 49th Intersci. Conf. Antimicrob. Agents Chemother. American Society for Microbiology, Washington, DC.