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Voriconazol versus anfotericina B o fluconazol en pacientes oncológicos con neutropenia

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References

Referencias de los estudios incluidos en esta revisión

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Herbrecht 2002 {published and unpublished data}

Herbrecht R, Denning DW, Patterson TF, Bennett JE, Greene RE, Oestmann JW et al. Voriconazole versus amphothericin B for primary therapy of invasive aspergillosis. The New England Journal of Medicine 2002;347:408-15. CENTRAL

Walsh 2002 {published and unpublished data}

Walsh TJ, Pappas P, Winston DJ, Lazarus HM, Petersen F, Rafalli J et al. Voriconazole compared with liposomal amphothericin B for empirical antifungal therapy in patients with neutropenia and persistent fever. The New England Journal of Medicine 2002;346:225-34. CENTRAL

Wingard 2010 {published data only}

Wingard JR, Carter SL, Walsh TJ et al. Randomized, double-blind trial of fluconazole versus voriconazole for prevention of invasive fungal infection after allogeneic hematopoietic cell transplantation. Blood 2010;116:5111-8. CENTRAL

Referencias de los estudios excluidos de esta revisión

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Ally 2001 {published data only}

Ally R, Schürmann D, Kreisel W, Carosi G, Aguirrebengoa K, Dupont B et al. A randomized, double-blind, double-dummy, multicenter trial of voriconazole and fluconazole in the treatment of esophageal candidiasis in immunocompromised patients. Clinical Infectious Diseases 2001;33:1447-54. CENTRAL

Referencias de los estudios en espera de evaluación

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Mandhaniya 2011 {published data only}10.1097/MPH.0b013e3182331bc7

Mandhaniya S, Swaroop C, Thulkar S, Vishnubhatla S, Kabra SK, Xess I, Bakhshi S. Oral voriconazole versus intravenous low dose amphotericin B for primary antifungal prophylaxis in pediatric acute leukemia induction: a prospective, randomized, clinical study. Journal of Pediatric Hematology/Oncology December 2011;33(8):e333-41. CENTRAL

Referencias adicionales

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Blot 2002

Blot F, Ede C, Nitenberg GM. Voriconazole versus amphotericin B for invasive aspergillosis. The New England Journal of Medicine 2002;347:2080-1.

Edwards 1997

Edwards JE, Bodey GB, Bowden RA, Büchner T, de Pauw BE, Filler SG et al. International conference for the development of a consensus on the management and prevention of severe candidal infections. Clinical Infectious Diseases 1997;25:43-59.

Espinel‐Ingroff 2001

Espinel-Ingrof A. In vitro fungicidal activities of voriconazole, itraconazole, and amphotericin B against opportunistic moniliaceous and dematiaceous fungi. Journal of Clinical Microbiology 2001;39:954-8.

Girmenia 2011

Girmenia C et al. Voriconazole prophylaxis and the risk of invasive fungal infection after allogeneic HCT. (E-letter) Blood 4 Feb, 2011.

Gøtzsche 2002a

Gøtzsche PC, Johansen HK. Nystatin prophylaxis and treatment in severely immunodepressed patients. Cochrane Database of Systematic Reviews 2002, Issue 4. Art.No.: CD002003. DOI: 10.1002/14651858.CD002033. [DOI: 10.1002/14651858]

Gøtzsche 2002b

Gøtzsche PC, Johansen HK. Routine versus selective antifungal administration for control of fungal infections in patients with cancer. Cochrane Database of Systematic Reviews 2002, Issue 2. Art.No.: CD000026. DOI: 10.1002/14651858.CD000026. [DOI: 10.1002/14651858]

Hughes 2002

Hughes W, Armstrong D, Bodey G, Bow E, Brown A, Calandra T. Lipid formulations of amphothericin B for empirical treatment of fever and neutropenia (reply). Clinical Infectious Diseases 2002;35:897-8.

Imhof 2004

Imhof A, Arunmozhi B, Fredricks DN, Englund JA, Marr KA. Breakthrough fungal infections in stem cell transplant recipients receiving voriconazole. Clinical Infectious Diseases 2004;39:743-6.

Johansen 2000

Johansen HK, Gøtzsche PC. Amphotericin B lipid soluble formulations versus amphotericin B in cancer patients with neutropenia. Cochrane Database of Systematic Reviews 2000, Issue 3. Art. No.: CD000969. DOI: 10.1002/14651858.CD000969. [DOI: 10.1002/14651858]

Johansen 2002

Johansen HK, Gøtzsche PC. Amphothericin B versus fluconazole for controlling fungal infections in neutropenic cancer patients. Cochrane Database of Systematic Reviews 2002, Issue 2. Art. No.: CD000239. DOI: 10.1002/14651858.CD000239. [DOI: 10.1002/14651858]

Karthaus 2002

Karthaus M. Voriconazole versus amphotericin B for invasive aspergillosis. The New England Journal of Medicine 2002;347:2080-1.

Pearson 2003

Pearson MM, Rogers PD, Cleary JD, Chapman SW. Voriconazole: A new triazole antifungal agent. The Annals of Pharmacotherapy 2003;37:420-32.

Powers 2002

Powers JH, Dixon CA, Goldberger MJ. Voriconazole versus liposomal amphotericin B in patients with neutropenia and persistent fever. The New England Journal of Medicine 2002;346:289-90.

Richardson 1998

Richardson MD, Kokki MH. Antifungal therapy in "bone marrow failure". British Journal of Haematology 1998;100:619-28.

Ringdén 1991

Ringdén O, Meunier F, Tollemar J, Ricci P, Tura S, Kuse E et al. Efficacy of amphothericin B encapsulated in liposomes (AmBisome) in the treatment of invasive fungal infections in immunocompromised patients. Journal of Antimicrobial Chemotherapy 1991;28:73-82.

Verfaillie 1991

Verfaillie C, Weisdorf D, Haake R, Hostetter M, Ramsay N, McGlave P. Candida infections in bone marrow transplant recipients. Bone Marrow Transplantation 1991;8:177-84.

Walsh 1990

Walsh TJ. Role of surveillance cultures in prevention and treatment of fungal infections. Journal of the National Cancer Institute. Monographs 1990;9:43-5.

Walsh 2004

Walsh TJ, Teppler H, Donowitz GR, Maertens JA, Baden LR, Dmoszynska A. Caspofungin versus liposomal amphothericin B for empirical antifungal therapy in patients with persistent fever and neutropenia. The New England Journal of Medicine 2004;351:1391-402.

Characteristics of studies

Characteristics of included studies [ordered by study ID]

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Herbrecht 2002

Study characteristics

Methods

Allocation concealment: Central randomisation, minimisation with four stratification factors
Blinding of study: No

Participants

391 patients randomised
Excluded: 50 patients excluded from the voriconazole group and 52 patients from the amphothericin B group

Interventions

Voriconazole: Intravenous loading dose of 6 mg/kg twice within the first 24 hours, maintenance dose of 4 mg/kg twice daily for at least seven days, followed by 200 mg orally twice daily
Amphothericin B deoxycholate: 1 to 1.5 mg/kg/day intravenously

Outcomes

Total mortality
Invasive fungal infections
Use of escape drugs
Nephrotoxicity
Other adverse events

Notes

Follow‐up period (days): 84
Support: Pfizer

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Low risk

A ‐ Adequate

Blinding (performance bias and detection bias)
All outcomes

High risk
Walsh 2002

Study characteristics

Methods

Allocation concealment: computer‐generated randomization with two per block design, 1:1 ratio
Blinding of study: No

Participants

871 patients randomised
Excluded: 34
Mainly leukaemia, but also other cancer patients and patients receiving bone marrow transplantation

Interventions

Voriconazole: Intravenous loading dose of 6 mg/kg twice within the first 24 hours, maintenance dose of 3 mg/kg twice daily, or 200 mg orally twice daily after at least 3 days of intravenous therapy
Liposomal amphotericin B: 3 mg/kg/day intravenously

Outcomes

Total mortality
Invasive fungal infections
Use of escape drugs
Nephrotoxicity
Other adverse events

Notes

Follow‐up period (days): Median of 7 days in both groups. Non‐inferiority trial with composite endpoint
Support: Pfizer

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

High risk

C ‐ Inadequate

Blinding (performance bias and detection bias)
All outcomes

High risk
Wingard 2010

Study characteristics

Methods

Randomization in a 1:1 ratio in permuted blocks (size not stated).

Participants

600 patients with leukaemia or other haematopoietic disorders receiving

allogeneic haematopoietic stem cell transplantation treated prophylactically with either voriconazole or fluconazole.

Interventions

Voriconazole: 200 mg orally twice daily for 100 days.

Fluconazole 400 mg once daily for 100 days.

Outcomes

Primary outcome: Fungal free survival at 180 days

Secondary outcomes: incidence of invasive fungal infections. Time to invasive fungal infections. Six month and 1 year relapse free survival. Overall survival. Time to and duration of empiric antifungal therapy. Frequency of adverse events. Incidence of acute or chronic graft‐versus‐host disease

Notes

The follow‐up period was 180 days and 1 year

Supported by a grant from the National Institutes of Health and an "unrestricted educational grant" from Pfizer

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

1:1 permutated blocks, unclear if allocation concealment was obtained

Blinding (performance bias and detection bias)
All outcomes

Low risk

The clinician, patient and the data review board were blinded

Characteristics of excluded studies [ordered by study ID]

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Study

Reason for exclusion

Ally 2001

All patients had oesophageal candidiasis, which is not an invasive fungal infection according to our inclusion criteria; in addition, 94% of the patients had AIDS